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tPBM for Autism

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 8 weeks

Awards & highlights

Study Summary

This trial will test a new treatment for ASD and measure its safety, tolerability, and effectiveness.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,933 Previous Clinical Trials

13,198,427 Total Patients Enrolled

42 Trials studying Autism Spectrum Disorder

3,074 Patients Enrolled for Autism Spectrum Disorder

T. Atilla Ceranoglu, MDPrincipal InvestigatorMassachusetts General Hospital

1 Previous Clinical Trials

60 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there openings for individuals to participate in the trial?

"Clinicaltrials.gov informs us that this medical trial is currently seeking participants; the original posting date was February 11th, 2022 and it has been recently amended on May 2nd, 2022."

Answered by AI

How extensive is the participant pool for this medical experiment?

"Affirmative. According to clinicaltrials.gov, this research project is on the hunt for 54 volunteers from one medical centre and was initially posted on February 11th 2022 with recent edits dated May 2nd 2022."

Answered by AI

What is the ultimate goal of this research endeavor?

"The primary aim of this trial, which is set to last an average of 8 weeks, will evaluate the change in ASD symptoms based on scores from the Social Responsiveness Scale-2nd Edition (SRS-2). Assessments related to treatment's effect on associated psychopathology such as Attention Deficit Hyperactivity Disorder (ADHD) and social cognition functions will be conducted with the Clinical Global Impression of Improvement in ADHD scale (CGI-ADHD-I), Massachusetts General Hospital Social Emotional Competence Scale (MGH-SEC Scale), and Behavior Rating Inventory of Executive Function - Adult Self Report Version (BRIEF-"

Answered by AI

Does your research encompass elderly individuals aged 85 years and above?

"Eligible individuals for this trial must be between 18 and 59 years old."

Answered by AI

Could I become a participant in this medical experiment?

"With the goal of recruiting 54 participants, this trial is seeking individuals between 18 and 59 years old with autism spectrum disorder. Interested applicants must meet certain requirements such as: being able to comprehend the study's purpose; possessing a valid decision-making capacity; having an SRS raw score no less than 85 combined with CGI-ASD severity score equal or above 4; conforming to Diagnostic and Statistical Manual-5th edition diagnostic criteria for Autism Spectrum Disorder (DSM 5) established by clinical diagnostic interview; displaying sufficient communication capabilities in order to collaborate effectively with investigators/study coordinators involved in the project. Furthermore, if female potential"

Answered by AI