Clinical trial NCT04366258: Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression
Official title: Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: MDD, neuromodulation, transcranial photobiomodulation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-04-28
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
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
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
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
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
Secondary outcomes:
measure: Change in Brain Temperature During High-Irradiance t-PBM
timeFrame: Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7
measure: Change in Brain Temperature During Middle-Irradiance t-PBM
timeFrame: Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7
measure: Change in Brain Temperature During Low-Irradiance t-PBM
timeFrame: Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7
measure: Change in Brain Temperature During Sham Treatment
timeFrame: Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7
measure: Change in Columbia Suicide Severity Rating Scale (C-SSRS) Suicide Ideation Score
timeFrame: Baseline, Follow-up (Week 8)
measure: Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Prior to First Treatment
timeFrame: Baseline
measure: Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following High-Irradiance t-PBM
timeFrame: Immediately Post-Intervention, up to Week 7 in total
measure: Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Middle-Irradiance t-PBM
timeFrame: Immediately Post-Intervention, up to Week 7 in total
measure: Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Low-Irradiance t-PBM
timeFrame: Immediately Post-Intervention, up to Week 7 in total
measure: Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Sham Treatment
timeFrame: Immediately Post-Intervention, up to Week 7 in total
measure: t-PBM Self-Report Questionnaire (TSRQ) Score Following High-Irradiance t-PBM
timeFrame: Immediately Post-Intervention, up to Week 7 in total
measure: t-PBM Self-Report Questionnaire (TSRQ) Score Following Middle-Irradiance t-PBM
timeFrame: Immediately Post-Intervention, up to Week 7 in total
measure: t-PBM Self-Report Questionnaire (TSRQ) Score Following Low-Irradiance t-PBM
timeFrame: Immediately Post-Intervention, up to Week 7 in total
measure: t-PBM Self-Report Questionnaire (TSRQ) Score Following Sham Treatment
timeFrame: Immediately Post-Intervention, up to Week 7 in total
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: New York University
state: New York
city: Orangeburg
country: United States
facility: Nathan Kline Institute
state: New York
Study officials:
affiliation: NYU Langone Health
name: Dan Iosifescu, MD
role: PRINCIPAL_INVESTIGATOR
References: