Photobiomodulation in Autism Spectrum Disorder (ASD)

Not Applicable

Completed

• Conditions: Autism; Autism Spectrum Disorder
• Interventions: Device: Transcranial LED Therapy (Participants ages 9-17); Device: Transcranial LED Therapy (Participants ages 18-59)

• Registration Number: NCT03724552
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The purpose of this 8-week open-label study is to assess the tolerability, safety, and efficacy of Transcranial LED Therapy in patients with Autism Spectrum Disorder (ASD). The investigators propose to enroll up to 30 subjects of both genders ages 9-59 years with intact intellectual functions who meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Autism Spectrum Disorder (ASD).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-13
• Study First Submitted: 2018-10-02
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-30
• Primary Completion: 2019-11-25
• Study Completion: 2019-11-25
• Results First Submitted: 2023-05-02
• Results First Submitted QC: 2023-07-25
• Results First Posted: 2023-07-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transcranial LED Therapy (Participants ages 9-17)	Transcranial LED Therapy (Participants ages 9-17)	Transcranial Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm-850nm) is applied to forebrain.
Transcranial LED Therapy (Participants ages 18-59)	Transcranial LED Therapy (Participants ages 18-59)	Transcranial Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm-850nm) is applied to forebrain.

Primary Outcome Measures

Name	Time	Method
Number of Participants With CGI Improvement Scores of ≤ 2 at Week 8	8 weeks	The Clinical Global Impression Improvement scale (CGI-ASD-I) is a clinician rated measure of ASD improvement. Improvement scores range from 1 (very much improved) to 7 (very much worse).
Change in ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale.	Baseline to 8 weeks	Change in ASD symptoms as measured by change from baseline on the Social Responsiveness Scale 2 (SRS-2) scale.; The SRS-2 is a 65-item rating scale completed that is used to measure the severity of autism spectrum symptoms as they occur in natural settings. The SRS-2 School Age form is completed by a parent or guardian for patients ages 9-17 and the SRS-2 Adult Self-report is completed by patients ages 18-59. Total raw scores range from 0 to 195, with higher scores indicating increased symptom severity.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States