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The purpose of the study is to investigate whether transcranial, high-intensity LED placed on the scalp can improve working memory in people who have sustained a concussion with lingering effects or a mild brain injury.
This is a four month, outpatient, single center study investigating whether transcranial, high intensity LED applied outside the skull can improve frontal lobe executive function and working memory in participants with chronic, mild Traumatic Brain Injury (TBI), with or without mild posttraumatic stress disorder (PTSD), due to closed head injury.
Participants will sign the Informed Consent Form(ICF) before Neuropsychological Screening test are administered. If the participant's neuropsychological screening test scores meet the Inclusion/Exclusion criteria and the participant meets the other Inclusion/Exclusion criteria, then he/she will be tested again on the tests that are part of the Neuropsychological Outcome Measures, the week before the Transcranial LED treatments, and during the week after the last LED treatment and again at one and two months after the last LED treatment. Treatment with Transcranial LED will be for 6 weeks. Participants will be treated three times per week: Monday, Wednesday and Friday. A total of 18 Transcranial LED treatments will be administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial LED Treatment | Experimental | All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MedX Health Phototherapy (light therapy) | Device | The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each. |
| Measure | Description | Time Frame |
|---|---|---|
| Stroop Test for Executive Function - Trial 3 - Inhibition | Stroop Test for Executive Function - Trial 3 (D-KEFS) - Inhibition measures executive function, inhibition that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes. | Baseline and 1-Week, 1-month and 2-months after final LED Treatment |
| Stroop Test for Executive Function - Trial 4 Inhibition Switching | Stroop Test for Executive Function - Trial 4 (D-KEFS) Inhibition Switching that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes. | Baseline and 1-Week, 1-Month and 2-Months after the Final LED Treatment |
| California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5 | California Verbal Learning Test-II (CVLT-II) Total, Trials 1 - 5 measures word recall on trials 1-5 that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes. | Baseline and 1-Week, 1-Month and 2-Months after Final LED Treatment |
| California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall | California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall measures word recall after a 20 minute delay that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes. | Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment |
| Controlled Oral Word Association Test (FAS) | Controlled Oral Word Association Test (FAS) measures verbal fluency that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes. | Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ross D Zafonte, DO | Spaulding Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21172691 | Result | Hashmi JT, Huang YY, Osmani BZ, Sharma SK, Naeser MA, Hamblin MR. Role of low-level laser therapy in neurorehabilitation. PM R. 2010 Dec;2(12 Suppl 2):S292-305. doi: 10.1016/j.pmrj.2010.10.013. | |
| 21182447 | Result | Naeser MA, Saltmarche A, Krengel MH, Hamblin MR, Knight JA. Improved cognitive function after transcranial, light-emitting diode treatments in chronic, traumatic brain injury: two case reports. Photomed Laser Surg. 2011 May;29(5):351-8. doi: 10.1089/pho.2010.2814. Epub 2010 Dec 23. |
| Label | URL |
|---|---|
| Department of Physical Medicine and Rehabilitation at Spaulding Hospital - Research | View source |
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22 study subjects signed the consent but only 11 completed the study. The 11 that did not completed the study either did not meet the inclusion criteria at Screening or were lost to follow-up after they screened for the study.
Recruitment for the study began in April 2010. Potential subjects were recruited through several different methods - Spaulding Rehabilitation Hospital outpatient clinic, advertisements in local area newspapers, Brain Injury Association of MA and other area organizations that provide services to TBI survivors, flyers, on-line and social media.
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| ID | Title | Description |
|---|---|---|
| FG000 | Transcranial LED Treatment | Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation
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| ID | Title | Description |
|---|---|---|
| BG000 | Transcranial LED Treatment | All study subjects received LED treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy. Each session was 30 minutes in duration. Neuropsychological testing was administered at the following time points: within 1 week of the first LED treatment and within 1 week, 1 month & 2 months following the last LED treatment. The neuropsychological testing included: 1)Stroop test, 2) California Verbal Learning Test-II (CVLT- II), Short Delay Free & Cued Recall, Long Delay Free & Cued Recall, 3) Delis-Kaplan Executive Function (D-KEF) -Trails Test, 4) Controlled Oral Word Association Test (FAS), & 5) Digit Span, Forwards & Backwards. The following tests were not analyzed due to collinearity with other measures (r > .8): Short Delay Free & Cued Recall, Long Delay Cued Recall, & Delis-Kaplan Executive Function (D-KEF) -Trails Test. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Stroop Test for Executive Function - Trial 3 - Inhibition | Stroop Test for Executive Function - Trial 3 (D-KEFS) - Inhibition measures executive function, inhibition that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes. | All participants enrolled in the Transcranial LED Treatment Group | Posted | Mean | Standard Deviation | # of SD units | Baseline and 1-Week, 1-month and 2-months after final LED Treatment |
|
Over a period of 2 years 11 participants were studied with no adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transcranial LED Treatment | Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light and laser). Each session was 30 minutes in duration. |
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Small sample size & Open Protocol
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ross D. Zafonte, DO | Spaulding Rehabilitation Hospital | 617-952-5227 | rzafonte@partners.org |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Digit Span, Forwards and Backwards | Digit Span, Forwards and Backwards measures short-term auditory memory and working memory that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes. | Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Time Post TBI | This calculates the time elapsed since injury | Mean | Standard Deviation | years post TBI |
|
| Years of Education | Numbers of years of education | Mean | Standard Deviation | Years of Education |
|
| Units | Counts |
|---|
| Participants |
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|
|
| Primary | Stroop Test for Executive Function - Trial 4 Inhibition Switching | Stroop Test for Executive Function - Trial 4 (D-KEFS) Inhibition Switching that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes. | All participants enrolled in Transcranial LED Treatment Group | Posted | Mean | Standard Deviation | # of SD Units | Baseline and 1-Week, 1-Month and 2-Months after the Final LED Treatment |
|
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| Primary | California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5 | California Verbal Learning Test-II (CVLT-II) Total, Trials 1 - 5 measures word recall on trials 1-5 that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes. | All participants enrolled in Real Intervention Group | Posted | Mean | Standard Deviation | # of SD Units | Baseline and 1-Week, 1-Month and 2-Months after Final LED Treatment |
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| Primary | California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall | California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall measures word recall after a 20 minute delay that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes. | All participants enrolled in Transcranial LED Treatment Group | Posted | Mean | Standard Deviation | # of SD Units | Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment |
|
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| Primary | Controlled Oral Word Association Test (FAS) | Controlled Oral Word Association Test (FAS) measures verbal fluency that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes. | All participants enrolled in the Transcranial LED Treatment Group | Posted | Mean | Standard Deviation | # of SD units | Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment |
|
|
|
| Primary | Digit Span, Forwards and Backwards | Digit Span, Forwards and Backwards measures short-term auditory memory and working memory that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes. | All participants enrolled in the Transcranial LED Treatment Group | Posted | Mean | Standard Deviation | # of SD units | Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment |
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| 0 |
| 11 |
| 0 |
| 11 |
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D016489 | Head Injuries, Closed |
| D014949 | Wounds, Nonpenetrating |
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