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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
NYU Langone Health
Study ID
NCT05573074
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial Photobiomodulator — DEVICE
    Transcranial photobiomodulator delivers Near-Infrared Radiation (NIR) continuous middle irradiance (291.7 mW/cm2) to patients' foreheads.
  • Sham — DEVICE
    Transcranial Photobiomodulator delivers sham irradiance odes of 0 mW/cm2

Study Details

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.

Key Dates

Start date
Apr 1, 2023
Status verified
Feb 2026
Primary completion
Apr 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: tPBM Group
    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)
  • Active Comparator: Sham Group
    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)

Primary Outcome Measure

Percent change of cerebral blood flow (CBF) [ Time Frame: Baseline, Visit 18 (Week 10) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Harvard Medical SchoolBostonMassachusetts02114
Paolo Cassano, MD,PhD
[email protected]
617-726-6421
Paolo Cassano, MD,PhD (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Dan Iosifescu, MD, MSc
[email protected]
646-754-5156
Dan Iosifescu, MD, MSc (PRINCIPAL_INVESTIGATOR)
Thaddeus Tarpey, PhD (SUB_INVESTIGATOR)
Nathan Kline Institute for Psychiatric ResearchOrangeburgNew York10962
Katherine A Collins, MSW, PhD
[email protected]
845-398-6580
Katerine A Collins, MSW, PhD (PRINCIPAL_INVESTIGATOR)
Umit Tural, MD (PRINCIPAL_INVESTIGATOR)
Matthew Hoptman, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Harvard Medical School· Boston, MANYU Langone Health· New York, NYNathan Kline Institute for Psychiatric Research· Orangeburg, NY

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