Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression

NCT ID: NCT04366258

Last Updated: 2023-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2022-06-24

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Transcranial Photobiomodulator

Intervention Type: DEVICE

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).

Sham

Intervention Type: DEVICE

Transcranial Photobiomodulator delivers sham irradiance dose of 0 mW/cm2.

Interventions

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).

Intervention Type: DEVICE

Sham

Transcranial Photobiomodulator delivers sham irradiance dose of 0 mW/cm2.

Intervention Type: DEVICE

Other Intervention Names

LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dan Iosifescu, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

Massachusetts General Hospital

Charlestown, Massachusetts, United States

New York University

New York, New York, United States

Nathan Kline Institute

Orangeburg, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R61MH122647-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-00217

Identifier Type: -

Identifier Source: org_study_id