Photobiomodulation in Autism Spectrum Disorder (ASD)

NCT ID: NCT03724552

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-13
• Study Completion Date: 2019-11-25

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).

Conditions

Autism; Autism Spectrum Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Transcranial LED Therapy (Participants ages 9-17)

Intervention Type: DEVICE

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 Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm-850nm) is applied to forebrain.

Group Type: EXPERIMENTAL

Transcranial LED Therapy (Participants ages 18-59)

Intervention Type: DEVICE

Transcranial Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm-850nm) is applied to forebrain.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Exclusion Criteria

• Women of child-bearing potential must use a double-barrier method for birth control (e.g. condoms with spermicide) if sexually active.
• The subject is willing to participate in this study.

Subjects will be excluded from the study for any of the following reasons:

• Impaired intellectual capacity (clinically determined)
• Participant is unable to communicate due to delay in, or total lack of, spoken language development (grossly impaired language skills)
• Clinically unstable psychiatric conditions or judged to be at serious safety risk to self (suicidal risk) or others (within past 30 days).
• Subjects currently (within past 30 days) experiencing significant symptoms of major psychiatric disorders as clinically determined.
• Subjects with an unstable medical condition (that requires clinical attention).
• Active suicidal or homicidal ideation, as determined by clinical screening.
• The subject has a significant skin condition at the procedure sites (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo).
• The subject has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised AVM, implantable shunt - Hakim valve).
• Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment (in US: Visudine (verteporfin) - for age related macular degeneration; Aminolevulinic Acid- for actinic keratoses; Photofrin (porfimer sodium) - for esophageal cancer, non-small cell lung cancer; Levulan Kerastick (aminolevulinic acid HCl) - for actinic keratosis; 5-aminolevulinic acid (ALA)- for non-melanoma skin cancer)
• Current treatment with a psychotropic medication on a dose that has not been stable for at least 4 weeks prior to initiating study treatment.
• Investigator and his/her immediate family, defined as the investigator's spouse, parent, child, grandparent, or grandchild.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tolga A Ceranoglu

Associate Psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tolga A Ceranoglu, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Ceranoglu TA, Cassano P, Hoskova B, Green A, Dallenbach N, DiSalvo M, Biederman J, Joshi G. Transcranial Photobiomodulation in Adults with High-Functioning Autism Spectrum Disorder: Positive Findings from a Proof-of-Concept Study. Photobiomodul Photomed Laser Surg. 2022 Jan;40(1):4-12. doi: 10.1089/photob.2020.4986. Epub 2021 Dec 23.

Reference Type: DERIVED

PMID: 34941429 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016P002826

Identifier Type: -

Identifier Source: org_study_id