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Brain imaging may unlock early clues to autism in tuberous sclerosis

NCT ID NCT02461459

Knowledge-focused Sponsor: Boston Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This study investigates whether advanced brain imaging and electrical recordings can predict the presence and severity of autism spectrum disorder (ASD) and intellectual disability (ID) in people with tuberous sclerosis complex (TSC). Researchers will follow participants over time, using yearly assessments and MRI scans to track brain structure and function. The goal is to identify biomarkers that could lead to earlier diagnosis and better understanding of these conditions in the context of TSC.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to earlier detection and better understanding of autism and intellectual disability in people with tuberous sclerosis complex, potentially guiding future treatments.
What could go wrong
This is an observational study, so it won't test a treatment. The findings may not apply to all individuals with TSC, and the biomarkers identified may not be definitive.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

205 people

The number who actually took part.

Start date

May 2015

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

A total of 195 participants over the age of 18 months old with TSC and suspected or diagnosed ASD, ID, or combined ASD/ID will be enrolled into the study. Diagnosis of TSC will be based on established clinical or genetic criteria. Subjects will be enrolled from current and new TSC patients at each of the 6 centers.

Ages

18 months and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Meets genetic or clinical diagnostic criteria for TSC (Tuberous Sclerosis), the latter based on current recommendations for diagnostic evaluation, such as physical exam, neuroimaging, and echocardiogram. * Age criteria: over 18 months of age at time of enrollment. * Is diagnosed or suspected to have ASD and/or ID. * Primary communicative language is English Exclusion Criteria: * Has taken an investigational drug as part of another research study, within 30 days prior to study enrollment. * For subjects involved in imaging biomarker assessment: contraindications to 3T MRI scanning, such as metal implants/non-compatible medical devices or medical conditions, including vagus nerve stimulator. * For subjects involved in EEG/ERP biomarker assessment: contraindications to EEG/ERP, such as uncooperative or destructive behaviors preventing lead placement or capture by ERP/VEP equipment. Under age 2 or above age 11 at the time of enrollment. * Unwilling or unable to comply with study procedures and assessments.

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Conditions

The condition(s) this trial relates to.

autism autism spectrum disorder intellectual disability tuberous sclerosis tuberous sclerosis 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism disorder Intellectual disability Tuberous sclerosis

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Stanford University

    Palo Alto, California, 94304, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of California at Los Angeles

    Los Angeles, California, 90095, United States

  • University of Texas at Houston

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.