Evaluation of Transcranial Photobiomodulation in Autism Spectrum Disorder

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05363982
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 59 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial Photobiomodulation (tPBM) — DEVICE
    Transcranial Photobiomodulation (tPBM) is a novel treatment approach based on application of an invisible, non-ionizing electromagnetic wave that results in metabolic modulation in tissues targeted. This intervention consists of exposing bilaterally the frontal brain to the electromagnetic wave that penetrates the skin and skull into brain tissue, is non-invasive and minimally dissipated as thermal energy. Other Names: Niraxx G1 Headband
  • Placebo/ Sham — DEVICE
    The sham treatment will consist of applying all the procedures for the delivery of tPBM, but will not deliver light.

Study Details

The purpose of this 8-week double-blind randomized placebo-controlled study is to assess the tolerability, safety, and efficacy of tPBM in adult patients with ASD.

Key Dates

Start date
Feb 11, 2022
Status verified
Oct 2025
Primary completion
Oct 31, 2024
Completion
Oct 31, 2024

Study Design

Enrollment
41 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Transcranial Photobiomodulation (tPBM) Treatment
    Transcranial Photobiomodulation--a noninvasive intervention in which near-infrared light is applied to forebrain.
  • Sham Comparator: Placebo/ Sham Treatment
    The sham treatment will mimic the tPBM procedure, while delivering no light.

Primary Outcome Measure

Participant Improvement in ASD Symptoms as Assessed by the Clinical Global Impression of Improvement for Autism Spectrum Disorder (CGI-ASD-I) [ Time Frame: Week 8 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Massachusetts General Hospital· Boston, MA

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