Using near infrared light to improve blood flow in the brains of people with depression

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

This study is testing if shining near infrared light on the forehead can improve blood flow in the brains of people with depression and help them feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: NYU Langone Health (Academic / other)
• Locations: 3 sites (Boston, Massachusetts and 2 other locations)
• Trial ID: NCT05573074 on ClinicalTrials.gov

What this trial studies

This research investigates whether applying near infrared energy to the forehead can alter cerebral blood flow in individuals diagnosed with Major Depressive Disorder (MDD). The study involves approximately 60 participants who will undergo Magnetic Resonance Imaging (MRI) scans during a series of 16 treatment sessions, which will include either transcranial Photobiomodulation (tPBM) or a sham treatment in a randomized, double-blinded manner. The goal is to assess the effects of tPBM on brain blood flow and depressive symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 who have been diagnosed with Major Depressive Disorder and are experiencing significant depressive symptoms.

Not a fit: Patients who are unwilling or unable to comply with study requirements or those with serious comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel non-invasive treatment option for patients suffering from Major Depressive Disorder.

How similar studies have performed: While the use of transcranial Photobiomodulation is a relatively novel approach, preliminary studies have shown promise in similar applications for treating depression.

Eligibility criteria

Inclusion Criteria:

* 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:

  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
* 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.
* Significant skin conditions (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo) 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 tPBM (e.g., stent, clipped aneurysm, embolized AVM, implantable shunt - Hakim valve).
* Failure to meet standard MRI safety requirements (e.g., claustrophobia, non-removable piercings, implanted medical devices, other non-removable metals) as determined by the MRI Safety Checklist.

Where this trial is running

Boston, Massachusetts and 2 other locations

• Harvard Medical School — Boston, Massachusetts, United States (Recruiting)
• NYU Langone Health — New York, New York, United States (Recruiting)
• Nathan Kline Institute for Psychiatric Research — Orangeburg, New York, United States (Recruiting)

Study contacts

• Principal investigator: Dan Iosifescu, MD — NYU Langone Health
• Study coordinator: Dan Iosifescu, MD

Conditions Major Depressive Disorder; MDD, transcranial Photobiomodulation