Major Depressive Disorder
Conditions
Keywords
MDD, neuromodulation, transcranial photobiomodulation
Brief summary
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).
Detailed description
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.
Interventions
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).
DEVICESham
Transcranial Photobiomodulator delivers sham irradiance dose of 0 mW/cm2.
Sponsors
National Institute of Mental Health (NIMH)
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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: 1. Meeting diagnostic criteria for Major Depressive Disorder (MDD) in the past two weeks, at the DSM-5 Mini-International Neuropsychiatric Interview (MINI) 2. Inventory for Depressive Symptomatology Clinician-rated (IDS-C) total score ≥23 at screening 3. Depression symptoms are the primary target of treatment or treatment-seeking. * 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
* Unwilling or unable to comply with study requirements * Participants who are judged to be at serious and imminent suicidal (C-SSRS≥4) or homicide risk, or currently in crisis such that inpatient hospitalization or other crisis management should take priority * History of any or psychotic or bipolar disorder * Alcohol or substance use disorder, post-traumatic stress disorder, obsessive-compulsive disorder and eating disorders within the preceding 12 months * History of dementia, traumatic brain injury (TBI), or neurological disorders affecting the brain, including any history of stroke or seizure disorders requiring treatment in the last 5 years (even if controlled with medications) * Cognitive impairment significant as determined by the Montreal Cognitive Assessment (MOCA) \<22 * History of antisocial personality disorder, or any clinically significant personality trait that would, in the investigator's judgment, preclude safe study participation or impair ability to remain adherent with the treatment protocol. * History of significant treatment non-adherence or situations where the subjects are unlikely to adhere to treatment, in the opinion of the investigator * Pregnant (as confirmed by pregnancy test at screen) or nursing. * Currently undergoing device-based treatment for depression or taking medications for depression other than SSRIs or SNRIs. * Treatment resistance with failure to respond to more than two adequate treatments with FDA-approved antidepressant medications during current episode of major depressive disorder. * History of ECT in the last 12 months; lifetime history of VNS; lifetime treatment resistance to any FDA-approved device-based treatment for major depressive disorder; device-based interventions for depression will need to be discontinued at least 8 weeks prior to screen. * Serious, unstable medical illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, hematologic disease; defined as any medical illness which is not well-controlled with standard-of-care medications * Clinically significant abnormal findings of laboratory parameters including urine toxicology screen for drugs of abuse or at physical examination * Clinical or laboratory evidence of uncontrolled hypothyroidism; if maintained on thyroid medication must be euthyroid for at least 1 month before screening. * Past intolerance or hypersensivity to t-PBM. * Significant skin conditions on the subject's scalp that are found in the area of the procedure sites. * Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment. * Any type of implants in the head, whose functioning might be affected by t-PBM. * Failure to meet standard MRI safety requirements as determined by the MRI Safety Checklist.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During High-Irradiance t-PBM | 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7 | 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. |
| Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Middle-Irradiance t-PBM | 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7 | 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. |
| Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Low-Irradiance t-PBM | 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7 | 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. |
| Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Sham Treatment | 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Columbia Suicide Severity Rating Scale (C-SSRS) Suicide Ideation Score | Baseline, Follow-up (Week 8) | 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. |
| Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Prior to First Treatment | Baseline | 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 |
| Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following High-Irradiance t-PBM | Immediately Post-Intervention, up to Week 7 in total | 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 |
| Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Middle-Irradiance t-PBM | Immediately Post-Intervention, up to Week 7 in total | 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 |
| Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Low-Irradiance t-PBM | Immediately Post-Intervention, up to Week 7 in total | 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 |
| Change in Brain Temperature During High-Irradiance t-PBM | Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7 | 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. |
| t-PBM Self-Report Questionnaire (TSRQ) Score Following High-Irradiance t-PBM | Immediately Post-Intervention, up to Week 7 in total | 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. |
| t-PBM Self-Report Questionnaire (TSRQ) Score Following Middle-Irradiance t-PBM | Immediately Post-Intervention, up to Week 7 in total | 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. |
| t-PBM Self-Report Questionnaire (TSRQ) Score Following Low-Irradiance t-PBM | Immediately Post-Intervention, up to Week 7 in total | 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. |
| t-PBM Self-Report Questionnaire (TSRQ) Score Following Sham Treatment | Immediately Post-Intervention, up to Week 7 in total | 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. |
| Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Sham Treatment | Immediately Post-Intervention, up to Week 7 in total | 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 |
| Change in Brain Temperature During Middle-Irradiance t-PBM | Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7 | 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. |
| Change in Brain Temperature During Low-Irradiance t-PBM | Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7 | 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. |
| Change in Brain Temperature During Sham Treatment | Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7 | 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. |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Population All participants from whom baseline characteristics were collected. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Baseline Assessments | Early Termination | 3 |
| Baseline Assessments | Screen Failure | 21 |
Baseline characteristics
| Characteristic | Overall Study Population |
|---|---|
| Age, Continuous | 37.08 years STANDARD_DEVIATION 15.65 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 26 | 0 / 28 | 0 / 29 |
| other Total, other adverse events | 6 / 27 | 7 / 26 | 8 / 28 | 6 / 29 |
| serious Total, serious adverse events | 0 / 27 | 0 / 26 | 0 / 28 | 0 / 29 |
Outcome results
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.
Time frame: 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t-PBM at High Irradiance | Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During High-Irradiance t-PBM | 1.12 Percent change in raw frontal BOLD | Standard Deviation 25.07 |
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.
Time frame: 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t-PBM at High Irradiance | Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Low-Irradiance t-PBM | -43.51 Percent change in raw frontal BOLD | Standard Deviation 25.2 |
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.
Time frame: 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t-PBM at High Irradiance | Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Middle-Irradiance t-PBM | 100.36 Percent change in raw frontal BOLD | Standard Deviation 70.72 |
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.
Time frame: 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t-PBM at High Irradiance | Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Sham Treatment | 1.99 Percent change in raw frontal BOLD | Standard Deviation 30.65 |
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.
Time frame: Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t-PBM at High Irradiance | Change in Brain Temperature During High-Irradiance t-PBM | -0.38 Change in degrees (Celsius) | Standard Deviation 0.91 |
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.
Time frame: Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t-PBM at High Irradiance | Change in Brain Temperature During Low-Irradiance t-PBM | -0.1 Change in degrees (Celsius) | Standard Deviation 0.81 |
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.
Time frame: Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t-PBM at High Irradiance | Change in Brain Temperature During Middle-Irradiance t-PBM | -0.4 Change in degrees (Celsius) | Standard Deviation 0.86 |
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.
Time frame: Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t-PBM at High Irradiance | Change in Brain Temperature During Sham Treatment | -0.33 Change in degrees (Celsius) | Standard Deviation 0.49 |
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.
Time frame: Baseline, Follow-up (Week 8)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t-PBM at High Irradiance | Change in Columbia Suicide Severity Rating Scale (C-SSRS) Suicide Ideation Score | 0.07 score on a scale | Standard Deviation 0.83 |
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
Time frame: Immediately Post-Intervention, up to Week 7 in total
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t-PBM at High Irradiance | Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following High-Irradiance t-PBM | 21.19 score on a scale | Standard Deviation 12.04 |
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
Time frame: Immediately Post-Intervention, up to Week 7 in total
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t-PBM at High Irradiance | Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Low-Irradiance t-PBM | 20.96 score on a scale | Standard Deviation 12.06 |
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
Time frame: Immediately Post-Intervention, up to Week 7 in total
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t-PBM at High Irradiance | Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Middle-Irradiance t-PBM | 20.1 score on a scale | Standard Deviation 13.04 |
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
Time frame: Immediately Post-Intervention, up to Week 7 in total
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t-PBM at High Irradiance | Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Sham Treatment | 23.69 score on a scale | Standard Deviation 11.43 |
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
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t-PBM at High Irradiance | Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Prior to First Treatment | 27.81 score on a scale | Standard Deviation 11.26 |
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.
Time frame: Immediately Post-Intervention, up to Week 7 in total
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t-PBM at High Irradiance | t-PBM Self-Report Questionnaire (TSRQ) Score Following High-Irradiance t-PBM | 4.42 score on a scale | Standard Deviation 1.41 |
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.
Time frame: Immediately Post-Intervention, up to Week 7 in total
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t-PBM at High Irradiance | t-PBM Self-Report Questionnaire (TSRQ) Score Following Low-Irradiance t-PBM | 4.08 score on a scale | Standard Deviation 1.6 |
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.
Time frame: Immediately Post-Intervention, up to Week 7 in total
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t-PBM at High Irradiance | t-PBM Self-Report Questionnaire (TSRQ) Score Following Middle-Irradiance t-PBM | 4.46 score on a scale | Standard Deviation 1.58 |
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.
Time frame: Immediately Post-Intervention, up to Week 7 in total
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t-PBM at High Irradiance | t-PBM Self-Report Questionnaire (TSRQ) Score Following Sham Treatment | 3.77 score on a scale | Standard Deviation 1.58 |