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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61MH122647-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will compare the effect of three transcranial photobiomodulation (t-PBM) doses (high, middle, and low irradiance) to sham t-PBM on PFC CBF as assessed with fMRI (BOLD) in this multi-center, phase I, double-blinded, dose-ranging, controlled, crossover study of 30 subjects with MDD. All eligible participants will undergo four sessions of t-PBM during fMRI so that they experience irradiances of 50, 300 and 700 mW/cm2 as well as sham. The order of dose administration will be randomized and t-PBM will be administered with the LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0).
The purpose of this research study is to determine if application of near infrared energy to the forehead can change blood flow in the brains of people with depression. Near infrared energy is like light but is not visible to the human eye. This research study will compare near infrared exposure with a placebo or sham procedure. The sham procedure will look and feel just like the near infrared procedure but won't include near infrared exposure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with MDD | Experimental | Participants will undergo 4 Transcranial Photobiomodulation (t-PBM) treatment visits and receive 1 irradiance dose per visit. The order of dose administration is randomized so patients receive each irradiance dose (50 mW/cm2; 300 mW/cm2; 770 mW/cm2), as well as a sham dose (0 mW/cm2), once over the 4 treatment visits. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Photobiomodulator | Device | Delivers laser-generated Near-Infrared Radiation (NIR) to forehead at 3 doses of irradiance - High (770 mW/cm2), Middle (300 mW/cm2), and Low (50 mW/cm2). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During High-Irradiance t-PBM | CBF is measured as Blood Oxygen Level Dependent (BOLD) signal on functional magnetic resonance imaging (fMRI). BOLD signal reflects changes in regional CBF that delineate regional activity. A positive BOLD signal marks an increase in regional blood flow, while a negative BOLD signal marks a decrease in regional blood flow. A positive percent change indicates that blood flow increased in the region of interest between scans, a negative percent change indicates blood flow decreased between scans. Approximately 60 minutes of fMRI data are recorded in the left and right dorsolateral prefrontal cortical regions of interest at each transcranial photobiomodulation (t-PBM) treatment visit, including: approximately 20 minutes prior to t-PBM administration, approximately 20 minutes coinciding with t-PBM administration, and approximately 20 minutes following t-PBM administration. | 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7 |
| Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Middle-Irradiance t-PBM | CBF is measured as Blood Oxygen Level Dependent (BOLD) signal on functional magnetic resonance imaging (fMRI). BOLD signal reflects changes in regional CBF that delineate regional activity. A positive BOLD signal marks an increase in regional blood flow, while a negative BOLD signal marks a decrease in regional blood flow. A positive percent change indicates that blood flow increased in the region of interest between scans, a negative percent change indicates blood flow decreased between scans. Approximately 60 minutes of fMRI data are recorded in the left and right dorsolateral prefrontal cortical regions of interest at each transcranial photobiomodulation (t-PBM) treatment visit, including: approximately 20 minutes prior to t-PBM administration, approximately 20 minutes coinciding with t-PBM administration, and approximately 20 minutes following t-PBM administration. | 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7 |
| Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Low-Irradiance t-PBM | CBF is measured as Blood Oxygen Level Dependent (BOLD) signal on functional magnetic resonance imaging (fMRI). BOLD signal reflects changes in regional CBF that delineate regional activity. A positive BOLD signal marks an increase in regional blood flow, while a negative BOLD signal marks a decrease in regional blood flow. A positive percent change indicates that blood flow increased in the region of interest between scans, a negative percent change indicates blood flow decreased between scans. Approximately 60 minutes of fMRI data are recorded in the left and right dorsolateral prefrontal cortical regions of interest at each transcranial photobiomodulation (t-PBM) treatment visit, including: approximately 20 minutes prior to t-PBM administration, approximately 20 minutes coinciding with t-PBM administration, and approximately 20 minutes following t-PBM administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brain Temperature During High-Irradiance t-PBM | Changes computed using data recorded with magnetic resonance (MR) thermometry scans taken immediately before and after the 20-minute transcranial photobiomodulation (t-PBM) treatment administration. | Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7 |
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Inclusion Criteria:
Participants must be able to give written informed consent and follow study procedures
Participants must have major depressive disorder; all the following conditions need to be met to ensure presence of significant depression symptoms:
Women of child-bearing potential must agree to use adequate contraception
Participants taking medications or psychotherapy approved for the treatment of major depressive disorder will need to be stable for at least 8 weeks prior to screen
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Iosifescu, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Charlestown | Massachusetts | 02129 | United States | ||
| New York University |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data and upon reasonable request. Requests should be directed to Dr. Kate Collins, PhD (email: Kate.Collins@nki.rfmh.org). To gain access, data requestors will need to sign a data access agreement.
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The cross-over study enrolled 55 participants. The 31 participants who met study criteria were assigned to receive 4 irradiance dose levels of t-PBM in random order across 4 t-PBM sessions (1 dose per session, doses assigned in random order: t-PBM at High Irradiance, t-PBM at Middle Irradiance, t-PBM at Low Irradiance, and Sham).
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With MDD | Participants underwent 4 Transcranial Photobiomodulation (t-PBM) treatment visits and received 1 irradiance dose per visit. The order of dose administration is randomized so patients receive each irradiance dose (50 mW/cm2; 300 mW/cm2; 770 mW/cm2), as well as a sham dose (0 mW/cm2), once over the 4 treatment visits. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Assessments |
|
| |||||||||||||||||||||
| Randomized Cross-Over |
|
Baseline characteristic information was collected from 30 of the 31 participants who completed the baseline period and were assigned to treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Population | All participants from whom baseline characteristics were collected. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During High-Irradiance t-PBM | CBF is measured as Blood Oxygen Level Dependent (BOLD) signal on functional magnetic resonance imaging (fMRI). BOLD signal reflects changes in regional CBF that delineate regional activity. A positive BOLD signal marks an increase in regional blood flow, while a negative BOLD signal marks a decrease in regional blood flow. A positive percent change indicates that blood flow increased in the region of interest between scans, a negative percent change indicates blood flow decreased between scans. Approximately 60 minutes of fMRI data are recorded in the left and right dorsolateral prefrontal cortical regions of interest at each transcranial photobiomodulation (t-PBM) treatment visit, including: approximately 20 minutes prior to t-PBM administration, approximately 20 minutes coinciding with t-PBM administration, and approximately 20 minutes following t-PBM administration. | Posted | Mean | Standard Deviation | Percent change in raw frontal BOLD | 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7 |
|
4 weeks
systematic assessment (study MD monitored for AEs at every post-intervention visit)
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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 | t-PBM at High Irradiance | At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Warm Skin (forehead) | Skin and subcutaneous tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dan Iosifescu, MD | NYU Langone Health | 646-754-5156 | Dan.Iosifescu@nyulangone.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2021 | Apr 7, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 28, 2022 | Jul 1, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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|
| Sham | Device | Transcranial Photobiomodulator delivers sham irradiance dose of 0 mW/cm2. |
|
| 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7 |
| Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Sham Treatment | CBF is measured as Blood Oxygen Level Dependent (BOLD) signal on functional magnetic resonance imaging (fMRI). BOLD signal reflects changes in regional CBF that delineate regional activity. A positive BOLD signal marks an increase in regional blood flow, while a negative BOLD signal marks a decrease in regional blood flow. A positive percent change indicates that blood flow increased in the region of interest between scans, a negative percent change indicates blood flow decreased between scans. Approximately 60 minutes of fMRI data are recorded in the left and right dorsolateral prefrontal cortical regions of interest at each transcranial photobiomodulation (t-PBM) treatment visit, including: approximately 20 minutes prior to t-PBM administration, approximately 20 minutes coinciding with t-PBM administration, and approximately 20 minutes following t-PBM administration. | 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7 |
| Change in Brain Temperature During Middle-Irradiance t-PBM |
Changes computed using data recorded with magnetic resonance (MR) thermometry scans taken immediately before and after the 20-minute transcranial photobiomodulation (t-PBM) treatment administration. |
| Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7 |
| Change in Brain Temperature During Low-Irradiance t-PBM | Changes computed using data recorded with magnetic resonance (MR) thermometry scans taken immediately before and after the 20-minute transcranial photobiomodulation (t-PBM) treatment administration. | Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7 |
| Change in Brain Temperature During Sham Treatment | Changes computed using data recorded with magnetic resonance (MR) thermometry scans taken immediately before and after the 20-minute transcranial photobiomodulation (t-PBM) treatment administration. | Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7 |
| Change in Columbia Suicide Severity Rating Scale (C-SSRS) Suicide Ideation Score | C-SSRS systematically tracks suicidal ideation and behavior. The total score range is 0 (no ideation is present) to 5 (active suicidal ideation with specific plan and intent). The higher the score, the greater one's suicidal ideation. Any score greater than 0 is important and may indicate the need for mental health intervention. | Baseline, Follow-up (Week 8) |
| Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Prior to First Treatment | 55-item self-assessment measuring severity levels of side effects. Participants rank each item on a 4-point Likert scale ranging from 0-3, where: 0 = None; 1 = Mild; 2 = Moderate; and 3 = Severe. The total score is the sum of responses. Scores range from 0 to 165; higher scores indicate greater severity of side effects | Baseline |
| Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following High-Irradiance t-PBM | 55-item self-assessment measuring severity levels of side effects. Participants rank each item on a 4-point Likert scale ranging from 0-3, where: 0 = None; 1 = Mild; 2 = Moderate; and 3 = Severe. The total score is the sum of responses. Scores range from 0 to 165; higher scores indicate greater severity of side effects | Immediately Post-Intervention, up to Week 7 in total |
| Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Middle-Irradiance t-PBM | 55-item self-assessment measuring severity levels of side effects. Participants rank each item on a 4-point Likert scale ranging from 0-3, where: 0 = None; 1 = Mild; 2 = Moderate; and 3 = Severe. The total score is the sum of responses. Scores range from 0 to 165; higher scores indicate greater severity of side effects | Immediately Post-Intervention, up to Week 7 in total |
| Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Low-Irradiance t-PBM | 55-item self-assessment measuring severity levels of side effects. Participants rank each item on a 4-point Likert scale ranging from 0-3, where: 0 = None; 1 = Mild; 2 = Moderate; and 3 = Severe. The total score is the sum of responses. Scores range from 0 to 165; higher scores indicate greater severity of side effects | Immediately Post-Intervention, up to Week 7 in total |
| Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Sham Treatment | 55-item self-assessment measuring severity levels of side effects. Participants rank each item on a 4-point Likert scale ranging from 0-3, where: 0 = None; 1 = Mild; 2 = Moderate; and 3 = Severe. The total score is the sum of responses. Scores range from 0 to 165; higher scores indicate greater severity of side effects | Immediately Post-Intervention, up to Week 7 in total |
| t-PBM Self-Report Questionnaire (TSRQ) Score Following High-Irradiance t-PBM | 3-item self-report assessment of potential inconveniences and discomforts from the transcranial photobiomodulation (t-PBM). Participants rank each item on various Likert scales. The total score is the sum of responses. Total score ranges from 3-18; higher scores indicate greater perceived inconveniences and discomforts associated with t-PBM use. | Immediately Post-Intervention, up to Week 7 in total |
| t-PBM Self-Report Questionnaire (TSRQ) Score Following Middle-Irradiance t-PBM | 3-item self-report assessment of potential inconveniences and discomforts from the transcranial photobiomodulation (t-PBM). Participants rank each item on various Likert scales. The total score is the sum of responses. Total score ranges from 3-18; higher scores indicate greater perceived inconveniences and discomforts associated with t-PBM use. | Immediately Post-Intervention, up to Week 7 in total |
| t-PBM Self-Report Questionnaire (TSRQ) Score Following Low-Irradiance t-PBM | 3-item self-report assessment of potential inconveniences and discomforts from the transcranial photobiomodulation (t-PBM). Participants rank each item on various Likert scales. The total score is the sum of responses. Total score ranges from 3-18; higher scores indicate greater perceived inconveniences and discomforts associated with t-PBM use. | Immediately Post-Intervention, up to Week 7 in total |
| t-PBM Self-Report Questionnaire (TSRQ) Score Following Sham Treatment | 3-item self-report assessment of potential inconveniences and discomforts from the transcranial photobiomodulation (t-PBM). Participants rank each item on various Likert scales. The total score is the sum of responses. Total score ranges from 3-18; higher scores indicate greater perceived inconveniences and discomforts associated with t-PBM use. | Immediately Post-Intervention, up to Week 7 in total |
| New York |
| New York |
| 10016 |
| United States |
| Nathan Kline Institute | Orangeburg | New York | 10962 | United States |
| Received t-PBM at Low Irradiance |
|
| Received t-PBM at Sham Irradiance |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | t-PBM at High Irradiance | At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2). |
|
|
| Primary | Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Middle-Irradiance t-PBM | CBF is measured as Blood Oxygen Level Dependent (BOLD) signal on functional magnetic resonance imaging (fMRI). BOLD signal reflects changes in regional CBF that delineate regional activity. A positive BOLD signal marks an increase in regional blood flow, while a negative BOLD signal marks a decrease in regional blood flow. A positive percent change indicates that blood flow increased in the region of interest between scans, a negative percent change indicates blood flow decreased between scans. Approximately 60 minutes of fMRI data are recorded in the left and right dorsolateral prefrontal cortical regions of interest at each transcranial photobiomodulation (t-PBM) treatment visit, including: approximately 20 minutes prior to t-PBM administration, approximately 20 minutes coinciding with t-PBM administration, and approximately 20 minutes following t-PBM administration. | Posted | Mean | Standard Deviation | Percent change in raw frontal BOLD | 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7 |
|
|
|
| Primary | Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Low-Irradiance t-PBM | CBF is measured as Blood Oxygen Level Dependent (BOLD) signal on functional magnetic resonance imaging (fMRI). BOLD signal reflects changes in regional CBF that delineate regional activity. A positive BOLD signal marks an increase in regional blood flow, while a negative BOLD signal marks a decrease in regional blood flow. A positive percent change indicates that blood flow increased in the region of interest between scans, a negative percent change indicates blood flow decreased between scans. Approximately 60 minutes of fMRI data are recorded in the left and right dorsolateral prefrontal cortical regions of interest at each transcranial photobiomodulation (t-PBM) treatment visit, including: approximately 20 minutes prior to t-PBM administration, approximately 20 minutes coinciding with t-PBM administration, and approximately 20 minutes following t-PBM administration. | Posted | Mean | Standard Deviation | Percent change in raw frontal BOLD | 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7 |
|
|
|
| Primary | Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Sham Treatment | CBF is measured as Blood Oxygen Level Dependent (BOLD) signal on functional magnetic resonance imaging (fMRI). BOLD signal reflects changes in regional CBF that delineate regional activity. A positive BOLD signal marks an increase in regional blood flow, while a negative BOLD signal marks a decrease in regional blood flow. A positive percent change indicates that blood flow increased in the region of interest between scans, a negative percent change indicates blood flow decreased between scans. Approximately 60 minutes of fMRI data are recorded in the left and right dorsolateral prefrontal cortical regions of interest at each transcranial photobiomodulation (t-PBM) treatment visit, including: approximately 20 minutes prior to t-PBM administration, approximately 20 minutes coinciding with t-PBM administration, and approximately 20 minutes following t-PBM administration. | Posted | Mean | Standard Deviation | Percent change in raw frontal BOLD | 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7 |
|
|
|
| Secondary | Change in Brain Temperature During High-Irradiance t-PBM | Changes computed using data recorded with magnetic resonance (MR) thermometry scans taken immediately before and after the 20-minute transcranial photobiomodulation (t-PBM) treatment administration. | Posted | Mean | Standard Deviation | Change in degrees (Celsius) | Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7 |
|
|
|
| Secondary | Change in Brain Temperature During Middle-Irradiance t-PBM | Changes computed using data recorded with magnetic resonance (MR) thermometry scans taken immediately before and after the 20-minute transcranial photobiomodulation (t-PBM) treatment administration. | Posted | Mean | Standard Deviation | Change in degrees (Celsius) | Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7 |
|
|
|
| Secondary | Change in Brain Temperature During Low-Irradiance t-PBM | Changes computed using data recorded with magnetic resonance (MR) thermometry scans taken immediately before and after the 20-minute transcranial photobiomodulation (t-PBM) treatment administration. | Posted | Mean | Standard Deviation | Change in degrees (Celsius) | Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7 |
|
|
|
| Secondary | Change in Brain Temperature During Sham Treatment | Changes computed using data recorded with magnetic resonance (MR) thermometry scans taken immediately before and after the 20-minute transcranial photobiomodulation (t-PBM) treatment administration. | Posted | Mean | Standard Deviation | Change in degrees (Celsius) | Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7 |
|
|
|
| Secondary | Change in Columbia Suicide Severity Rating Scale (C-SSRS) Suicide Ideation Score | C-SSRS systematically tracks suicidal ideation and behavior. The total score range is 0 (no ideation is present) to 5 (active suicidal ideation with specific plan and intent). The higher the score, the greater one's suicidal ideation. Any score greater than 0 is important and may indicate the need for mental health intervention. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Follow-up (Week 8) |
|
|
|
| Secondary | Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Prior to First Treatment | 55-item self-assessment measuring severity levels of side effects. Participants rank each item on a 4-point Likert scale ranging from 0-3, where: 0 = None; 1 = Mild; 2 = Moderate; and 3 = Severe. The total score is the sum of responses. Scores range from 0 to 165; higher scores indicate greater severity of side effects | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following High-Irradiance t-PBM | 55-item self-assessment measuring severity levels of side effects. Participants rank each item on a 4-point Likert scale ranging from 0-3, where: 0 = None; 1 = Mild; 2 = Moderate; and 3 = Severe. The total score is the sum of responses. Scores range from 0 to 165; higher scores indicate greater severity of side effects | Posted | Mean | Standard Deviation | score on a scale | Immediately Post-Intervention, up to Week 7 in total |
|
|
|
| Secondary | Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Middle-Irradiance t-PBM | 55-item self-assessment measuring severity levels of side effects. Participants rank each item on a 4-point Likert scale ranging from 0-3, where: 0 = None; 1 = Mild; 2 = Moderate; and 3 = Severe. The total score is the sum of responses. Scores range from 0 to 165; higher scores indicate greater severity of side effects | Posted | Mean | Standard Deviation | score on a scale | Immediately Post-Intervention, up to Week 7 in total |
|
|
|
| Secondary | Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Low-Irradiance t-PBM | 55-item self-assessment measuring severity levels of side effects. Participants rank each item on a 4-point Likert scale ranging from 0-3, where: 0 = None; 1 = Mild; 2 = Moderate; and 3 = Severe. The total score is the sum of responses. Scores range from 0 to 165; higher scores indicate greater severity of side effects | Posted | Mean | Standard Deviation | score on a scale | Immediately Post-Intervention, up to Week 7 in total |
|
|
|
| Secondary | Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Sham Treatment | 55-item self-assessment measuring severity levels of side effects. Participants rank each item on a 4-point Likert scale ranging from 0-3, where: 0 = None; 1 = Mild; 2 = Moderate; and 3 = Severe. The total score is the sum of responses. Scores range from 0 to 165; higher scores indicate greater severity of side effects | Posted | Mean | Standard Deviation | score on a scale | Immediately Post-Intervention, up to Week 7 in total |
|
|
|
| Secondary | t-PBM Self-Report Questionnaire (TSRQ) Score Following High-Irradiance t-PBM | 3-item self-report assessment of potential inconveniences and discomforts from the transcranial photobiomodulation (t-PBM). Participants rank each item on various Likert scales. The total score is the sum of responses. Total score ranges from 3-18; higher scores indicate greater perceived inconveniences and discomforts associated with t-PBM use. | Posted | Mean | Standard Deviation | score on a scale | Immediately Post-Intervention, up to Week 7 in total |
|
|
|
| Secondary | t-PBM Self-Report Questionnaire (TSRQ) Score Following Middle-Irradiance t-PBM | 3-item self-report assessment of potential inconveniences and discomforts from the transcranial photobiomodulation (t-PBM). Participants rank each item on various Likert scales. The total score is the sum of responses. Total score ranges from 3-18; higher scores indicate greater perceived inconveniences and discomforts associated with t-PBM use. | Posted | Mean | Standard Deviation | score on a scale | Immediately Post-Intervention, up to Week 7 in total |
|
|
|
| Secondary | t-PBM Self-Report Questionnaire (TSRQ) Score Following Low-Irradiance t-PBM | 3-item self-report assessment of potential inconveniences and discomforts from the transcranial photobiomodulation (t-PBM). Participants rank each item on various Likert scales. The total score is the sum of responses. Total score ranges from 3-18; higher scores indicate greater perceived inconveniences and discomforts associated with t-PBM use. | Posted | Mean | Standard Deviation | score on a scale | Immediately Post-Intervention, up to Week 7 in total |
|
|
|
| Secondary | t-PBM Self-Report Questionnaire (TSRQ) Score Following Sham Treatment | 3-item self-report assessment of potential inconveniences and discomforts from the transcranial photobiomodulation (t-PBM). Participants rank each item on various Likert scales. The total score is the sum of responses. Total score ranges from 3-18; higher scores indicate greater perceived inconveniences and discomforts associated with t-PBM use. | Posted | Mean | Standard Deviation | score on a scale | Immediately Post-Intervention, up to Week 7 in total |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 6 |
| 27 |
| EG001 | t-PBM at Medium Irradiance | At 1 of the 4 t-PBM sessions, participants were administered t-PBM at medium irradiance (500 mW/cm2). | 0 | 26 | 0 | 26 | 7 | 26 |
| EG002 | t-PBM at Low Irradiance | At 1 of the 4 t-PBM sessions, participants were administered t-PBM at low irradiance (50 mW/cm2). | 0 | 28 | 0 | 28 | 8 | 28 |
| EG003 | Sham | At 1 of the 4 t-PBM sessions, participants were administered t-PBM at sham irradiance (0 mW/cm2). | 0 | 29 | 0 | 29 | 6 | 29 |
| Headache | Nervous system disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Skin Pressure (forehead) | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Claustrophobia | Psychiatric disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Nightmares | Psychiatric disorders | Systematic Assessment |
|
| Eye Irritation | Eye disorders | Systematic Assessment |
|
| Confusion | Psychiatric disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided