Autism Spectrum Disorder Trial, Recruiting NCT02461446 Sponsor: Boston Children's Hospital Condition: Autism Spectrum Disorder
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Autism Spectrum Disorder Trial, Recruiting

NCT02461446
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 months or older who have a documented clinical diagnosis of autism spectrum disorder (ASD) and/or a confirmed PTEN gene mutation, as verified by a medical or mental health professional.
  • People with a larger-than-usual head size (head circumference at or above the 98th percentile) may be eligible for a specific group in the trial.
  • For children and young people, a parent or legal guardian must be willing to provide consent to participate.
  • For adults, consent from the person themselves or their legal guardian is required.
  • Young people who are able to do so will be asked to give their own agreement to participate, in line with research ethics guidelines.
  • Families with more than one child who meets the criteria may enroll as many children as they wish, with a separate consent form completed for each child.
  • The primary language spoken for communication must be English.

Who may not be able to join:

  • People who are unwilling or unable to follow the study's procedures and assessments.
  • People with a serious medical condition that would prevent safe participation in the study activities.
  • For those being considered for the optional brain imaging (MRI) part of the study, people who have metal implants, certain medical devices, or medical conditions that are not compatible with a 3T MRI scanner — including a vagus nerve stimulator — would not be eligible for that component.
  • For those being considered for the optional brainwave recording (EEG/ERP) part of the study, people whose behaviour would prevent the equipment from being placed or used correctly, or who are under age 2 or over age 11 at the time of joining, would not be eligible for that component.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Antonio Hardan, MD, Stanford University

Phone: 617-919-7068

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Boston Children's Hospital
Registry
ClinicalTrials.gov
Start date
1 May 2015
Est. completion
1 December 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in verbal abilities at 12 months; Change in communication ability at 12 months; Change in communication ability at 12 months; Change in verbal abilities at 24 months; Change in visual perception at 12 months; Change in working memory at 12 months; Change in processing speed at 12 months; Change in working memory at 24 months; Change in processing speed at 24 months; Change in visual perception at 24 months; Change in communication ability at 24 months; Change in communication ability at 24 months

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov