| Primary | Digit Span Forwards | Repeat a series of numbers, exactly as spoken, in the same order. Starts with 2 digits and continues to 7 digits in a row. Participant is given 2 attempts at each level. If 0/2 attempts are correct for a given level, testing is discontinued. Scoring: 2 points both trials per set; 1 point 1 trial; 0 points failed both trials Forwards; measures Attention/Executive Function with a min score of 0 and a max score of 14; higher score = better outcome | | Posted | | Mean | Standard Deviation | units on a scale | | within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
| | | Title | Denominators | Categories |
|---|
| T1 [within 1-2 weeks before LED treatment series] | - ParticipantsOG00025
- ParticipantsOG00123
| |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANOVA | Adjusted for baseline scores; co-variate adjustments did not affect any of the results | <0.01 | without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10 | Mean Difference (Final Values) | -0.55 | Standard Error of the Mean | 0.33 | 2-Sided | | | | | | | | Superiority | | |
|
| Primary | Digit Span Backwards | Repeat a series of numbers, in reverse order. Starts with 2 digits and continues to 7 digits in a row. Participant is given 2 attempts at each level. If 0/2 attempts are correct for a given level, the test is discontinued. Scoring: 2 points both trials correct for each set; 1point 1 trial correct; 0 points no trials Backwards; measures Attention/Executive Function with a min score of 0 and a max score of 14; higher score = better outcome | | Posted | | Mean | Standard Deviation | units on a scale | | within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Primary | Digit Span Total Forward + Backwards | Total (Forwards+Backwards); measures Attention/Executive Function; working memory with a min score of 0 and a max score of 28; higher score = better outcome | | Posted | | Mean | Standard Deviation | units on a scale | | within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Primary | Trails Condition 2 | Delis-Kaplan Executive Function (DKEFS) Trails 2; Number Sequencing; measures Attention/Executive Function Reaction Time with lower = better outcome Connect the numbers in consecutive order from 1 to 16, as quickly as possible. | | Posted | | Mean | Standard Deviation | seconds | | within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Primary | Trails Condition 4 | Delis-Kaplan Executive Function (DEKFS) Trails 4; Number-Letter Switching; measures Attention/Executive Function Reaction Time lower is better Connect numbers and letters, alternating between numbers and letters. (1-A-2-B...) as quickly as possible. Ends at P. | | Posted | | Mean | Standard Deviation | seconds | | within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Primary | Stroop Inhibition (Trial 3) | Color-Word Interference Test Trial 3; measures Attention/Executive Function; inhibition Reaction Time lower = better outcome Name the color ink each word is printed in for a series of words, as quickly as possible. | | Posted | | Mean | Standard Deviation | seconds | | Within 1-2 weeks before LED treatment series, within 1 week and 1 month after LED treatment series | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Primary | Stroop Inhibition/Switching | Color-Word Interference Test Trial 4 (Inhibition/Switching); measures Attention/Executive Function Reaction Time lower = better outcome Participants must sometimes name the color ink in which the word (color) is printed or, if there is a box around the word, they must read the word. | | Posted | | Mean | Standard Deviation | seconds | | Within 1-2 weeks before LED treatment series, within 1 week and 1 month after LED treatment series | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Primary | California Verbal Learning Test -II (CVLT-II) Total Trials 1-5 | CVLT-II Total Trials 1-5, measures Learning/Memory over 5 consecutive trials; with a min score of 0 and a max score of 80; higher score = better outcome Participant must immediately recall words from a 16 word list A read aloud by the examiner. The same list is presented for each of the 5 trials. Total across 5 trials is scored. | | Posted | | Mean | Standard Deviation | units on a scale | | within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Primary | CVLT-II, Short Delay Free Recall | California Verbal Learning Test -II, Short Delay Free Recall, measures Memory; with min score of 0 and a max score of 16; higher score = better outcome A second list B is presented for one trial of recall before asking participants to recall items from the first list A. Number of items recalled from list A is scored. | | Posted | | Mean | Standard Deviation | units on a scale | | within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Primary | CVLT-II, Short Delay Cued Recall | California Verbal Learning Test -II, Short Delay Cued Recall, measures Learning/Memory; with a min score of 0 and a max score of 16; higher score = better outcome Participants are now asked to recall items from list A again, but are given cues by category. (4 categories, 4 items each). Total is score across all 4 categories. | | Posted | | Mean | Standard Deviation | units on a scale | | within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Primary | CVLT-II Long Delay Free Recall | California Verbal Learning Test- II, Long Delay (20 min) Free Recall, measures Memory with a min score of 0 and a max score of 16; higher score = better outcome After a 20 minute delay (other tasks run during this delay), participant is asked to recall items from List A. Total is number of words recalled. | | Posted | | Mean | Standard Deviation | units on a scale | | within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Primary | CVLT-II Long Delay Cued Recall | California Verbal Learning Test- II, Long Delay (20 min) Cued Recall measures Memory; with a min score of 0 and a max score of 16; higher score = better outcome After 20 minute delay participant is given cues (4 categories) and asked to recall the words within each category. Total number of items recalled across all categories. | | Posted | | Mean | Standard Deviation | units on a scale | | within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Primary | Conner's Continuous Performance Test II (CPT) False Alarms | CPT; False Alarms (Administered on laptop computer) measures Selective and Sustained Attention percent errors; lower = better outcome Participant presses space bar when an X appears on screen. False alarms is number of errors made (responding to non-targets), reported as percentage. | | Posted | | Mean | Standard Deviation | percent errors | | within 1 week before LED treatment series, within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Primary | CPT Correct Detections, Reaction Time (RT) | Conner's Continuous Performance Test II; Mean Correct Detections, Reaction Time, (Administered on laptop computer) measures Selective and Sustained Attention; shorter = better outcome Participant must press the space bar when they see an X. Reaction Time for correct responses only. | | Posted | | Mean | Standard Deviation | seconds | | within 1 week before LED treatment series, within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Primary | Conner's Continuous Performance Test II (CPT), D' | Conner's Continuous Performance Test II (CPT); D' (sensitivity index) (Administered on laptop computer) measures Selective and Sustained Attention; ability to detect the signal (x) within noise; values range -2 to 2; higher value better Value d' is a measure of the difference between the signal (X) and noise (non-target letters) distributions, assessing the participant's discriminative power. | | Posted | | Mean | Standard Deviation | difference between distributions | | within 1 week before LED treatment series, within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Primary | Rey Osterrieth Complex Figure Test (ROCFT); Immediate Recall | ROCFT; Immediate Recall measures Visuospatial memory with min 0 and max 36; higher score better outcome Participant is presented with a figure. They are asked to copy the figure. Then they are immediately asked to recall and draw the figure. Figure is scored on 18 units; up to 2 points per unit Scoring based on accuracy and placement of figure parts: A score of 0, 0.5 recognizable and incorrectly placed, 1 accurate or correctly placed or 2 both accurate and correctly placed; 0 is given if part is omitted or unrecognizable. | | Posted | | Mean | Standard Deviation | units on a scale | | within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | |
|
| Primary | ROCFT, Delayed Recall | Rey Osterrieth Complex Figure Test (ROCFT); Delayed (20-min) Recall measures Visuospatial memory with min 0 and max 36; higher = better outcome Participant is asked to draw the figure from memory after a 20 minute delay (other tasks completed during this time). Figure has 18 units; Scoring is based on accuracy and placement: 0 if unrecognizable or omitted, .5 recognizable, 1 either accurate or correctly placed or 2 both accurate and correctly placed, per unit. | | Posted | | Mean | Standard Deviation | units on a scale | | within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Secondary | Beck Depression Inventory (BDI) | BDI; 21 item Questionnaire; Mood. With min 0 and max 63; 0-13 minimal; 14-19 mild, 20-29 moderate, 30-63 severe; lower scores = better outcome Score per item: 1-3 | | Posted | | Mean | Standard Deviation | units on a scale | | within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Secondary | PCL-Civilian Survey | Post Traumatic Stress Disorder 17-item, symptom questionnaire; higher scores indicates greater endorsement of symptoms with min 17 and max 85; Reliable decrease 5-10; Clinically meaningful decrease 10-20 points (Monson et al., 2008); Lower scores = better outcome Score ranges from 1-5 for each item. | | Posted | | Mean | Standard Deviation | units on a scale | | within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Secondary | Visual Analog Pain Rating | Visual Analog Pain Rating Scale (VAS); Current Pain Rating scale of 1-10; lower score = better outcome *must be lower than 7 at entry into study for study inclusion Participant rates current level of pain (includes body, muscular, headache etc) by marking a line on a continuous scale from 1-10. | | Posted | | Mean | Standard Deviation | units on a scale | | within 1-2 weeks of LED treatment, within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Secondary | Short Form McGill Pain Questionnaire | Short Form McGill Pain Questionnaire; Pain Rating (for the last 30 days) with min 0 and max 45; lower = better outcome Participant rates 15 types of pain (None = 0, mild = 1, moderate = 2, severe = 3). Totaled for all types of pain. | | Posted | | Mean | Standard Deviation | units on a scale | | within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Secondary | Pittsburgh Sleep Quality Index (PSQI) | Global Sleep Score with min score of 0 and max score of 27; lower score = better outcome 9 item questionnaire- make up 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction) with a min of 0 and max of 3 per component. Global score is total of the 7 component scores. | | Posted | | Mean | Standard Deviation | units on a scale | | 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Secondary | Karolinska Sleepiness Scale | Measure of Sleepiness; Participant indicates current level of sleepiness on a scale of 0 extremely alert to 10 extremely sleepy; lower score = better outcome | | Posted | | Mean | Standard Deviation | score on a scale | | 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Secondary | Short Form-36V Plus (PCS) | 36 Question General Health Survey/Questionnaire for Veterans; Physical Composite Score (PCS) measures endorsement of physical health symptoms related to physical problems which affect 7-areas (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health); Z-Score; lower = better outcome. | | Posted | | Mean | Standard Deviation | Z-Score | | within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Secondary | Short Form-36V Plus (MCS) | 36 Question General Health Survey/Questionnaire for Veterans; Mental Composite Score (MCS) measures endorsement of mental health symptoms which affect 7-areas (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health); Z-Score; lower score is better (based on scoring of the Veterans RAND 36 item Health Survey (SV-36) formerly Veterans SF-36. | | Posted | | Mean | Standard Deviation | Z-Score | | within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Secondary | Multidimensional Fatigue Inventory (MFI), General Score | Measures General Fatigue Levels; lower = better; General Fatigue Subscale = sum of items numbers 1, 5, 12 and 16 (max = 5, min =0 for each item) Max possible sum is 20. | | Posted | | Mean | Standard Deviation | units on a scale | | 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Secondary | Multidimensional Fatigue Inventory, Physical Score | Physical Score Subscale Measures Physical Fatigue Levels; lower = better outcome; sum of items numbers 2, 8, 14 and 20 (max = 5, min =0 for each item) | | Posted | | Mean | Standard Deviation | units on a scale | | 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Secondary | Multidimensional Fatigue Inventory, Reduced Activity Score | Reduced Activity Subscale measures fatigue levels during activity; lower = better outcome; sum of items numbers 3, 6, 10 and 17 (max = 5, min =0 for each item) Max possible sum is 20. | | Posted | | Mean | Standard Deviation | units on a scale | | 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Secondary | Multidimensional Fatigue Inventory, Reduced Motivation Activity | Reduced Motor Activity subscale measures if fatigue affects motivation levels; lower score = better outcome; sum of items numbers 4, 9, 15, and 18 (max = 5, min =0 for each item) Max possible sum is 20. | | Posted | | Mean | Standard Deviation | units on a scale | | 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|
| Secondary | Multidimensional Fatigue Inventory, Mental Fatigue | Mental Fatigue subscale measures mental fatigue levels; lower = better outcome; sum of items numbers 7, 11, 13 and 19 (max = 5, min =0 for each item) Max possible sum is 20. | | Posted | | Mean | Standard Deviation | units on a scale | | 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment | | | | ID | Title | Description |
|---|
| OG000 | Real LED Treatment Series | Participants in this group receive a series of 15 real LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices: Transcranial NIR, 830nm LED Helmet and two LED intranasal nose clips (633 nm, and 810 nm), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR 870nm LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. LEDs are FDA-cleared, non-significant risk. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. | | OG001 | Sham LED Treatment Series | Participants in this group first receive a series of 15 sham LED treatments (2 days/wk for 7.5 weeks) with the helmet and intranasal devices containing sham LEDs (no photons were emitted): Transcranial NIR, 830nm LED Helmet and two intranasal nose clips (sham LEDs), 28-minute treatment, 2 days/ week, 7.5 weeks, at least 48 hours between treatments. Additionally, two NIR sham LED cluster heads were placed over the L and R ears during the last 4 minutes of the treatment session. These participants were offered an optional Second Real Series of identical 15 real LED treatments. Both the participant and treater wore goggles that block red wavelength (from the red intranasal). Real and Sham LED devices look and feel identical. |
|