What side effects are associated with this type of intervention?

Common treatments for Autism Spectrum Disorder (ASD) that are similar to transcranial Photobiomodulation (tPBM) include various forms of neuromodulation such as transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS). Known side effects of these treatments are generally mild and may include headaches, scalp discomfort, tingling sensations, and lightheadedness. Serious adverse effects are rare but can include seizures, particularly in individuals with a predisposition to epilepsy. Overall, these treatments are considered to have a favorable safety profile when administered under medical supervision.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments for Autism Spectrum Disorder (ASD) that are directly similar to transcranial Photobiomodulation (tPBM). The FDA has approved medications like risperidone and aripiprazole to address irritability associated with ASD, but these are pharmacological treatments rather than non-invasive light therapies. Research into non-invasive brain stimulation techniques, including tPBM, is ongoing, but these methods have not yet received FDA approval for ASD treatment.

What other types of research exist?

Promising, novel alternatives to transcranial Photobiomodulation (tPBM) for Autism Spectrum Disorder (ASD) patients include: 1. Transcranial Magnetic Stimulation (TMS): Limited observational evidence suggests that TMS may be effective for various neurological conditions, including ASD. 2. Transcutaneous Supraorbital Nerve Stimulation: This method has shown efficacy in reducing pain intensity in migraine patients and could be explored for ASD. 3. Remote Electrical Neuromodulation: This involves nonpainful electrical skin stimulation and has shown promise in reducing acute migraine pain, which may be applicable to ASD treatment.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 8 weeks

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.

0 / 9Eligibility criteria met

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].