At a glance
ClinicalIndex Comparison Record- ✓Age 18-59 years
- ✓Diagnosed with Autism Spectrum Disorder per DSM-5 criteria
- ✓At least moderate ASD severity: SRS raw score ≥85 AND CGI-ASD severity ≥4
- ✓Capacity to provide informed consent and communicate with study team
- ✕Impaired intellectual capacity clinically determined
- ✕Unable to communicate due to severely delayed or absent spoken language
- ✕Clinically unstable psychiatric conditions or serious safety risk (suicidal/homicidal) within past 30 days
- ✕Significant symptoms of major psychiatric disorder within past 30 days
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Transcranial Photobiomodulation in Autism Spectrum Disorder: Double-Blind, Placebo-Controlled, Randomized Clinical Study of a Novel Approach
In Brief
A clinical study evaluating Transcranial Photobiomodulation (tPBM) and Placebo/ Sham for Autism Spectrum Disorder. Completed, enrolled 41 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
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
The sham treatment will consist of applying all the procedures for the delivery of tPBM, but will not deliver light.