NCT03724552

Photobiomodulation in Autism Spectrum Disorder (ASD)

Evaluation of LED Therapeutic Effect in Youth and Adults With Autism Spectrum Disorder: An Open-Label Pilot Study of a Novel Approach

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 9 Years – 59 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Autism
• Autism Spectrum Disorder

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2017-04-13
• Primary completion: 2019-11-25
• Completion: 2019-11-25
• First posted: 2018-10-30
• Last updated: 2024-07-11
• Results posted: 2023-07-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study