Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression - R33

NCT05573074 | Recruiting DMC FDA Device

• 1 other identifier: 22-01065
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Major Depressive Disorder

Keywords

MDD, transcranial Photobiomodulation

Outcome Measures

Primary Outcomes (2)

• Percent change of cerebral blood flow (CBF)

  Cerebral blood flow (CBF) is measured as Blood oxygen Level Dependent (BOLD) signal on functional magnetic resonance imaging (fMRI). BOLD signal reflect changes in regional cerebral blood flow that delineates 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.

  Baseline, Visit 18 (Week 10)

• Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score

  Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item diagnostic questionnaire that psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item is rated on a 0-6 scale, resulting in a total score range of 0-60. The higher the score, the more severe the depression.

  Baseline, Visit 17 (Week 9, endpoint)

Secondary Outcomes (8)

• Percent change of cerebral blood flow (CBF) at endpoint in relation to treatment outcome

  Baseline, Visit 18 (Week 10)]

• Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score

  Baseline, Visit 3 (Week 2)

• Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score

  Baseline, Visit 5 (Week 3)

• Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score

  Baseline, Visit 7 (Week 4)

• Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score

  Baseline, Visit 9 (Week 5)

Study Arms (2)

tPBM Group

EXPERIMENTAL

Visit 1: t-PBM at irradiance dose of 291.7 mW/cm2 (333s) Visit 2 - 18: randomized to receive active t-PBM of 291.7 mW/cm2 (333s) Visit 19: t-PBM at irradiance dose of 291.7 mW/cm2 (333s)

Device: Transcranial Photobiomodulator; Device: Sham

Sham Group

ACTIVE COMPARATOR

Visit 1: t-PBM at irradiance does of 291.7 mW/cm2 (333s) Visit 2 - 18: randomized to receive Sham of 0 mW/cm2 (333s) Visit 19: t-PBM at irradiance dose of 291.7 mW/cm2 (333s)

Device: Transcranial Photobiomodulator; Device: Sham

Interventions

Sham DEVICE

Transcranial Photobiomodulator delivers sham irradiance odes of 0 mW/cm2

Sham Group; tPBM Group

Transcranial Photobiomodulator DEVICE

Transcranial photobiomodulator delivers Near-Infrared Radiation (NIR) continuous middle irradiance (291.7 mW/cm2) to patients' foreheads.

Also known as: LightForce EXPi tPBM-2.0

Sham Group; tPBM Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be able to give written informed consent and follow study procedures
• Participants must be 18-65 years of age
• 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.

You may not qualify if:

• Unwilling or unable to comply with study requirements
• Patients 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
• Met diagnostic criteria for an alcohol or substance use disorder, post-traumatic stress disorder, obsessive-compulsive disorder, anorexia nervosa, or bulimia nervosa within the preceding 6 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
• Cognitive impairment significant as determined by the Montreal Cognitive Assessment (MOCA) \<22 or MOCA-Blind \<19.
• 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, SNRIs, or Wellbutrin (bupropion).
• 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 (such as ECT, TMS, VNS); 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 v 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 hypersensitivity to tPBM.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institutes of Health (NIH): collaborator

Study Sites (3)

Harvard Medical School

Boston, Massachusetts, 02114, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Nathan Kline Institute for Psychiatric Research

Orangeburg, New York, 10962, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Dan Iosifescu, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Iosifescu, MD

CONTACT

646-754-5156; Dan.Iosifescu@nyulangone.org

Anna Peterson

CONTACT

646-754-2260; Anna.Peterson@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 10, 2022
• Study Start: April 1, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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: Upon reasonable request, Requests should be directed to dan.iosifescu@nyulangone.org. To gain access, data requestors will need to sign a data access agreement

Locations

US (3)