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tPBM for Autism

N/A
Waitlist Available
Led By T. Atilla Ceranoglu, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female participants between 18 and 59 years of age (inclusive)
Fulfills Diagnostic and Statistical Manual-5th edition diagnostic criteria for autism spectrum disorder as established by the clinical diagnostic interview
Must not have
Impaired intellectual capacity (clinically determined). Participants' intellectual capacity will be assessed during the clinical evaluation and determination will be based on intact communicative language, ability to take personal care, history of holding a job and completion of high school (or equivalency credential), and no history of intellectual disability
Participant is unable to communicate due to delay in, or total lack of, spoken language development (grossly impaired language skills)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 8 weeks

Summary

This trial is testing a new light-based treatment called tPBM for adults with Autism Spectrum Disorder (ASD). The treatment aims to improve brain function by increasing energy production in brain cells. The study will evaluate if this treatment is safe and effective for reducing ASD symptoms.

Who is the study for?
Adults aged 18-59 with Autism Spectrum Disorder (ASD) who can understand the study and give informed consent are eligible. They should not have intellectual disabilities, unstable psychiatric conditions, or serious safety risks. Women must use double-barrier contraception if applicable.
What is being tested?
The trial is testing Transcranial Photobiomodulation (tPBM), a light therapy on the brain, against a placebo to see if it's safe and effective for treating ASD symptoms over an 8-week period in a randomized controlled setting.
What are the potential side effects?
Potential side effects of tPBM are not detailed here but generally could include discomfort at the treatment site or headaches. The trial aims to assess tolerability indicating close monitoring of any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 59 years old.
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I have been diagnosed with autism spectrum disorder.
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My autism symptoms are moderate to severe.
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I understand the study and can make decisions about my health care.
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I am using two forms of birth control if I can have children and am sexually active.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I can communicate, take care of myself, have worked or completed high school without a history of intellectual disability.
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I have significant difficulties or cannot speak at all.
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I have a skin condition like a rash or tattoo where the procedure will be done.
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I haven't used any light-activated drugs in the last 14 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
ASD symptoms as measured by change through study completion on the Social Responsiveness Scale-2nd Edition (SRS-2)
ASD symptoms as measured by change through study completion, on the Clinical Global Impression of Improvement of Autism Spectrum Disorder (CGI-ASD-I)
Secondary study objectives
Therapeutic procedure
Treatment-related changes in associated executive functions
Treatment-related changes in associated psychopathology
+5 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Transcranial Photobiomodulation (tPBM) TreatmentActive Control1 Intervention
Transcranial Photobiomodulation--a noninvasive intervention in which near-infrared light is applied to forebrain.
Group II: Placebo/ Sham TreatmentPlacebo Group1 Intervention
The sham treatment will mimic the tPBM procedure, while delivering no light.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Non-invasive neuromodulation therapies, such as transcranial Photobiomodulation (tPBM) and repetitive transcranial magnetic stimulation (rTMS), aim to stimulate specific areas of the brain to improve neural connectivity and function. tPBM uses light to penetrate the scalp and modulate neuronal activity, potentially enhancing cognitive and behavioral functions. rTMS uses magnetic fields to induce electrical currents in the brain, targeting areas associated with mood and behavior regulation. These treatments are significant for ASD patients as they offer potential improvements in social communication, sensory processing, and overall brain function without the need for invasive procedures or pharmacological interventions.
Neural Mechanisms of Qigong Sensory Training Massage for Children With Autism Spectrum Disorder: A Feasibility Study.[Good practice guidelines for the treatment of autistic spectrum disorders].

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,022 Previous Clinical Trials
13,317,498 Total Patients Enrolled
42 Trials studying Autism Spectrum Disorder
3,059 Patients Enrolled for Autism Spectrum Disorder
T. Atilla Ceranoglu, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
38 Total Patients Enrolled

Media Library

Placebo/ Sham Clinical Trial Eligibility Overview. Trial Name: NCT05363982 — N/A
Autism Spectrum Disorder Research Study Groups: Placebo/ Sham Treatment, Transcranial Photobiomodulation (tPBM) Treatment
Autism Spectrum Disorder Clinical Trial 2023: Placebo/ Sham Highlights & Side Effects. Trial Name: NCT05363982 — N/A
Placebo/ Sham 2023 Treatment Timeline for Medical Study. Trial Name: NCT05363982 — N/A
~11 spots leftby Dec 2025