Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT04366258
Status:
COMPLETED
Last Update Posted:
2023-06-05
First Post:
2020-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Dan.Iosifescu@nyulangone.org', 'phone': '646-754-5156', 'title': 'Dan Iosifescu, MD', 'organization': 'NYU Langone Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'description': 'systematic assessment (study MD monitored for AEs at every post-intervention visit)', 'eventGroups': [{'id': 'EG000', 'title': 't-PBM at High Irradiance', 'description': 'At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2).', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 6, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 't-PBM at Medium Irradiance', 'description': 'At 1 of the 4 t-PBM sessions, participants were administered t-PBM at medium irradiance (500 mW/cm2).', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 7, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 't-PBM at Low Irradiance', 'description': 'At 1 of the 4 t-PBM sessions, participants were administered t-PBM at low irradiance (50 mW/cm2).', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 8, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Sham', 'description': 'At 1 of the 4 t-PBM sessions, participants were administered t-PBM at sham irradiance (0 mW/cm2).', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 6, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Warm Skin (forehead)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Pressure (forehead)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Claustrophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nightmares', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During High-Irradiance t-PBM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 't-PBM at High Irradiance', 'description': 'At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.12', 'spread': '25.07', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7', 'description': '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.\n\nApproximately 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.', 'unitOfMeasure': 'Percent change in raw frontal BOLD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Middle-Irradiance t-PBM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 't-PBM at Medium Irradiance', 'description': 'At 1 of the 4 t-PBM sessions, participants were administered t-PBM at medium irradiance (500 mW/cm2).'}], 'classes': [{'categories': [{'measurements': [{'value': '100.36', 'spread': '70.72', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7', 'description': '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.\n\nApproximately 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.', 'unitOfMeasure': 'Percent change in raw frontal BOLD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Low-Irradiance t-PBM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 't-PBM at Low Irradiance', 'description': 'At 1 of the 4 t-PBM sessions, participants were administered t-PBM at low irradiance (50 mW/cm2).'}], 'classes': [{'categories': [{'measurements': [{'value': '-43.51', 'spread': '25.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7', 'description': '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.\n\nApproximately 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.', 'unitOfMeasure': 'Percent change in raw frontal BOLD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Sham Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham', 'description': 'At 1 of the 4 t-PBM sessions, participants were administered t-PBM at sham irradiance (0 mW/cm2).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.99', 'spread': '30.65', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7', 'description': '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.\n\nApproximately 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.', 'unitOfMeasure': 'Percent change in raw frontal BOLD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Brain Temperature During High-Irradiance t-PBM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 't-PBM at High Irradiance', 'description': 'At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.91', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7', 'description': '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.', 'unitOfMeasure': 'Change in degrees (Celsius)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Brain Temperature During Middle-Irradiance t-PBM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 't-PBM at Medium Irradiance', 'description': 'At 1 of the 4 t-PBM sessions, participants were administered t-PBM at medium irradiance (500 mW/cm2).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.86', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7', 'description': '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.', 'unitOfMeasure': 'Change in degrees (Celsius)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Brain Temperature During Low-Irradiance t-PBM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 't-PBM at Low Irradiance', 'description': 'At 1 of the 4 t-PBM sessions, participants were administered t-PBM at low irradiance (50 mW/cm2).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.81', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7', 'description': '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.', 'unitOfMeasure': 'Change in degrees (Celsius)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Brain Temperature During Sham Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham', 'description': 'At 1 of the 4 t-PBM sessions, participants were administered t-PBM at sham irradiance (0 mW/cm2).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.49', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7', 'description': '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.', 'unitOfMeasure': 'Change in degrees (Celsius)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Columbia Suicide Severity Rating Scale (C-SSRS) Suicide Ideation Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study Population', 'description': 'A total of 55 participants were enrolled in the trial; of whom 31 were assigned to receive 4 different irradiance dose levels of t-PBM across 4 t-PBM sessions (1 dose per session, doses assigned in random order: 5 mW/cm20 \\[Low Irradiance\\], 300 mW/cm2 \\[Medium Irradiance\\], ≥700 mW/cm2 \\[High Irradiance\\], and 0 mW/cm2 \\[Sham\\]). These 31 participants were assigned to each of the 4 arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.07', 'spread': '0.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-up (Week 8)', 'description': "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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Prior to First Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study Population', 'description': 'A total of 55 participants were enrolled in the trial; of whom 31 were assigned to receive 4 different irradiance dose levels of t-PBM across 4 t-PBM sessions (1 dose per session, doses assigned in random order: 5 mW/cm20 \\[Low Irradiance\\], 300 mW/cm2 \\[Medium Irradiance\\], ≥700 mW/cm2 \\[High Irradiance\\], and 0 mW/cm2 \\[Sham\\]). These 31 participants were assigned to each of the 4 arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.81', 'spread': '11.26', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': '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', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following High-Irradiance t-PBM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 't-PBM at High Irradiance', 'description': 'At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2).'}], 'classes': [{'categories': [{'measurements': [{'value': '21.19', 'spread': '12.04', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately Post-Intervention, up to Week 7 in total', 'description': '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', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Middle-Irradiance t-PBM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 't-PBM at Medium Irradiance', 'description': 'At 1 of the 4 t-PBM sessions, participants were administered t-PBM at medium irradiance (500 mW/cm2).'}], 'classes': [{'categories': [{'measurements': [{'value': '20.1', 'spread': '13.04', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately Post-Intervention, up to Week 7 in total', 'description': '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', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Low-Irradiance t-PBM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 't-PBM at Low Irradiance', 'description': 'At 1 of the 4 t-PBM sessions, participants were administered t-PBM at low irradiance (50 mW/cm2).'}], 'classes': [{'categories': [{'measurements': [{'value': '20.96', 'spread': '12.06', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately Post-Intervention, up to Week 7 in total', 'description': '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', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Sham Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham', 'description': 'At 1 of the 4 t-PBM sessions, participants were administered t-PBM at sham irradiance (0 mW/cm2).'}], 'classes': [{'categories': [{'measurements': [{'value': '23.69', 'spread': '11.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately Post-Intervention, up to Week 7 in total', 'description': '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', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 't-PBM Self-Report Questionnaire (TSRQ) Score Following High-Irradiance t-PBM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 't-PBM at High Irradiance', 'description': 'At 1 of the 4 t-PBM sessions, participants were administered t-PBM at high irradiance (at least 700 mW/cm2).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.42', 'spread': '1.41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately Post-Intervention, up to Week 7 in total', 'description': '3-item self-report assessment of potential inconveniences and discomforts from the transcranial photobiomodulation (t-PBM). Participants rank each item on various Likert scales.\n\nThe 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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 't-PBM Self-Report Questionnaire (TSRQ) Score Following Middle-Irradiance t-PBM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 't-PBM at Medium Irradiance', 'description': 'At 1 of the 4 t-PBM sessions, participants were administered t-PBM at medium irradiance (500 mW/cm2).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.46', 'spread': '1.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately Post-Intervention, up to Week 7 in total', 'description': '3-item self-report assessment of potential inconveniences and discomforts from the transcranial photobiomodulation (t-PBM). Participants rank each item on various Likert scales.\n\nThe 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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 't-PBM Self-Report Questionnaire (TSRQ) Score Following Low-Irradiance t-PBM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 't-PBM at Low Irradiance', 'description': 'At 1 of the 4 t-PBM sessions, participants were administered t-PBM at low irradiance (50 mW/cm2).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.08', 'spread': '1.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately Post-Intervention, up to Week 7 in total', 'description': '3-item self-report assessment of potential inconveniences and discomforts from the transcranial photobiomodulation (t-PBM). Participants rank each item on various Likert scales.\n\nThe 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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 't-PBM Self-Report Questionnaire (TSRQ) Score Following Sham Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham', 'description': 'At 1 of the 4 t-PBM sessions, participants were administered t-PBM at sham irradiance (0 mW/cm2).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.77', 'spread': '1.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately Post-Intervention, up to Week 7 in total', 'description': '3-item self-report assessment of potential inconveniences and discomforts from the transcranial photobiomodulation (t-PBM). Participants rank each item on various Likert scales.\n\nThe 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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients With MDD', 'description': '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.'}], 'periods': [{'title': 'Baseline Assessments', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'Early Termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}, {'title': 'Randomized Cross-Over', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'Received t-PBM at High Irradiance', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'Received t-PBM at Medium Irradiance', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'Received t-PBM at Low Irradiance', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'Received t-PBM at Sham Irradiance', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '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).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study Population', 'description': 'All participants from whom baseline characteristics were collected.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.08', 'spread': '15.65', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline characteristic information was collected from 30 of the 31 participants who completed the baseline period and were assigned to treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-16', 'size': 1351319, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-07T16:47', 'hasProtocol': True}, {'date': '2022-02-28', 'size': 365550, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-07-01T13:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-04', 'studyFirstSubmitDate': '2020-04-17', 'resultsFirstSubmitDate': '2023-04-07', 'studyFirstSubmitQcDate': '2020-04-27', 'lastUpdatePostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-04', 'studyFirstPostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During High-Irradiance t-PBM', 'timeFrame': '20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7', 'description': '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.\n\nApproximately 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': 'Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Middle-Irradiance t-PBM', 'timeFrame': '20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7', 'description': '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.\n\nApproximately 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': 'Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Low-Irradiance t-PBM', 'timeFrame': '20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7', 'description': '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.\n\nApproximately 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': 'Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Sham Treatment', 'timeFrame': '20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7', 'description': '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.\n\nApproximately 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.'}], 'secondaryOutcomes': [{'measure': 'Change in Brain Temperature During High-Irradiance t-PBM', 'timeFrame': 'Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7', 'description': '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.'}, {'measure': 'Change in Brain Temperature During Middle-Irradiance t-PBM', 'timeFrame': 'Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7', 'description': '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.'}, {'measure': 'Change in Brain Temperature During Low-Irradiance t-PBM', 'timeFrame': 'Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7', 'description': '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.'}, {'measure': 'Change in Brain Temperature During Sham Treatment', 'timeFrame': 'Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7', 'description': '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.'}, {'measure': 'Change in Columbia Suicide Severity Rating Scale (C-SSRS) Suicide Ideation Score', 'timeFrame': 'Baseline, Follow-up (Week 8)', 'description': "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."}, {'measure': 'Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Prior to First Treatment', 'timeFrame': 'Baseline', 'description': '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'}, {'measure': 'Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following High-Irradiance t-PBM', 'timeFrame': 'Immediately Post-Intervention, up to Week 7 in total', 'description': '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'}, {'measure': 'Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Middle-Irradiance t-PBM', 'timeFrame': 'Immediately Post-Intervention, up to Week 7 in total', 'description': '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'}, {'measure': 'Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Low-Irradiance t-PBM', 'timeFrame': 'Immediately Post-Intervention, up to Week 7 in total', 'description': '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'}, {'measure': 'Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Sham Treatment', 'timeFrame': 'Immediately Post-Intervention, up to Week 7 in total', 'description': '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'}, {'measure': 't-PBM Self-Report Questionnaire (TSRQ) Score Following High-Irradiance t-PBM', 'timeFrame': 'Immediately Post-Intervention, up to Week 7 in total', 'description': '3-item self-report assessment of potential inconveniences and discomforts from the transcranial photobiomodulation (t-PBM). Participants rank each item on various Likert scales.\n\nThe 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.'}, {'measure': 't-PBM Self-Report Questionnaire (TSRQ) Score Following Middle-Irradiance t-PBM', 'timeFrame': 'Immediately Post-Intervention, up to Week 7 in total', 'description': '3-item self-report assessment of potential inconveniences and discomforts from the transcranial photobiomodulation (t-PBM). Participants rank each item on various Likert scales.\n\nThe 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.'}, {'measure': 't-PBM Self-Report Questionnaire (TSRQ) Score Following Low-Irradiance t-PBM', 'timeFrame': 'Immediately Post-Intervention, up to Week 7 in total', 'description': '3-item self-report assessment of potential inconveniences and discomforts from the transcranial photobiomodulation (t-PBM). Participants rank each item on various Likert scales.\n\nThe 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.'}, {'measure': 't-PBM Self-Report Questionnaire (TSRQ) Score Following Sham Treatment', 'timeFrame': 'Immediately Post-Intervention, up to Week 7 in total', 'description': '3-item self-report assessment of potential inconveniences and discomforts from the transcranial photobiomodulation (t-PBM). Participants rank each item on various Likert scales.\n\nThe 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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['MDD, neuromodulation, transcranial photobiomodulation'], 'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants must be able to give written informed consent and follow study procedures\n* Participants must have major depressive disorder; all the following conditions need to be met to ensure presence of significant depression symptoms:\n\n 1. Meeting diagnostic criteria for Major Depressive Disorder (MDD) in the past two weeks, at the DSM-5 Mini-International Neuropsychiatric Interview (MINI)\n 2. Inventory for Depressive Symptomatology Clinician-rated (IDS-C) total score ≥23 at screening\n 3. Depression symptoms are the primary target of treatment or treatment-seeking.\n* Women of child-bearing potential must agree to use adequate contraception\n* 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\n\nExclusion Criteria:\n\n* Unwilling or unable to comply with study requirements\n* 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\n* History of any or psychotic or bipolar disorder\n* Alcohol or substance use disorder, post-traumatic stress disorder, obsessive-compulsive disorder and eating disorders within the preceding 12 months\n* 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)\n* Cognitive impairment significant as determined by the Montreal Cognitive Assessment (MOCA) \\<22\n* 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.\n* History of significant treatment non-adherence or situations where the subjects are unlikely to adhere to treatment, in the opinion of the investigator\n* Pregnant (as confirmed by pregnancy test at screen) or nursing.\n* Currently undergoing device-based treatment for depression or taking medications for depression other than SSRIs or SNRIs.\n* Treatment resistance with failure to respond to more than two adequate treatments with FDA-approved antidepressant medications during current episode of major depressive disorder.\n* 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.\n* 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\n* Clinically significant abnormal findings of laboratory parameters including urine toxicology screen for drugs of abuse or at physical examination\n* Clinical or laboratory evidence of uncontrolled hypothyroidism; if maintained on thyroid medication must be euthyroid for at least 1 month before screening.\n* Past intolerance or hypersensivity to t-PBM.\n* Significant skin conditions on the subject's scalp that are found in the area of the procedure sites.\n* Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment.\n* Any type of implants in the head, whose functioning might be affected by t-PBM.\n* Failure to meet standard MRI safety requirements as determined by the MRI Safety Checklist."}, 'identificationModule': {'nctId': 'NCT04366258', 'acronym': 'TRIADE', 'briefTitle': 'Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression', 'orgStudyIdInfo': {'id': '20-00217'}, 'secondaryIdInfos': [{'id': '1R61MH122647-01', 'link': 'https://reporter.nih.gov/quickSearch/1R61MH122647-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with MDD', 'description': '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.', 'interventionNames': ['Device: Transcranial Photobiomodulator', 'Device: Sham']}], 'interventions': [{'name': 'Transcranial Photobiomodulator', 'type': 'DEVICE', 'otherNames': ['LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)'], 'description': '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).', 'armGroupLabels': ['Patients with MDD']}, {'name': 'Sham', 'type': 'DEVICE', 'description': 'Transcranial Photobiomodulator delivers sham irradiance dose of 0 mW/cm2.', 'armGroupLabels': ['Patients with MDD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02129', 'city': 'Charlestown', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.37787, 'lon': -71.062}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10962', 'city': 'Orangeburg', 'state': 'New York', 'country': 'United States', 'facility': 'Nathan Kline Institute', 'geoPoint': {'lat': 41.04649, 'lon': -73.94958}}], 'overallOfficials': [{'name': 'Dan Iosifescu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}