Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression (TRIADE)
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| ClinicalTrials.gov Identifier: NCT04366258 |
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Recruitment Status :
Completed
First Posted : April 28, 2020
Results First Posted : June 5, 2023
Last Update Posted : June 5, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Major Depressive Disorder | Device: Transcranial Photobiomodulator Device: Sham | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 55 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression |
| Actual Study Start Date : | August 1, 2020 |
| Actual Primary Completion Date : | April 30, 2022 |
| Actual Study Completion Date : | June 24, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Patients with MDD
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.
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Device: Transcranial Photobiomodulator
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).
Other Name: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0) Device: Sham Transcranial Photobiomodulator delivers sham irradiance dose of 0 mW/cm2. |
- Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During High-Irradiance t-PBM [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Change in Brain Temperature During High-Irradiance t-PBM [ Time Frame: 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 Middle-Irradiance t-PBM [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 Columbia Suicide Severity Rating Scale (C-SSRS) Suicide Ideation Score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 Sham Treatment [ Time Frame: 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
- t-PBM Self-Report Questionnaire (TSRQ) Score Following High-Irradiance t-PBM [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participants must be able to give written informed consent and follow study procedures
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Participants must have major depressive disorder; all the following conditions need to be met to ensure presence of significant depression symptoms:
- Meeting diagnostic criteria for Major Depressive Disorder (MDD) in the past two weeks, at the DSM-5 Mini-International Neuropsychiatric Interview (MINI)
- Inventory for Depressive Symptomatology Clinician-rated (IDS-C) total score ≥23 at screening
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04366258
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Charlestown, Massachusetts, United States, 02129 | |
| United States, New York | |
| New York University | |
| New York, New York, United States, 10016 | |
| Nathan Kline Institute | |
| Orangeburg, New York, United States, 10962 | |
| Principal Investigator: | Dan Iosifescu, MD | NYU Langone Health |
Documents provided by NYU Langone Health:
| Responsible Party: | NYU Langone Health |
| ClinicalTrials.gov Identifier: | NCT04366258 |
| Other Study ID Numbers: |
20-00217 1R61MH122647-01 ( U.S. NIH Grant/Contract ) |
| First Posted: | April 28, 2020 Key Record Dates |
| Results First Posted: | June 5, 2023 |
| Last Update Posted: | June 5, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research. |
| Access Criteria: | 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Product Manufactured in and Exported from the U.S.: | No |
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MDD, neuromodulation, transcranial photobiomodulation |
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Depressive Disorder Depressive Disorder, Major Mood Disorders Mental Disorders |