Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD

NCT ID: NCT04532424

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-04

Study Completion Date

2029-12-01

Brief Summary

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Investigating the efficacy of a form of TMS called theta-burst stimulation for restricted and repetitive behavior in ASD.

Detailed Description

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Conditions

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Autism Spectrum Disorder Autism Asperger Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Participants will be assigned to one of 2 groups based on the presentation of restricted and repetitive behavior.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Targeting insistence on sameness

Group Type EXPERIMENTAL

Transcranial magnetic stimulation

Intervention Type DEVICE

Non-invasive brain stimulation technique that is FDA-approved for the treatment of refractory depression, OCD and migraine.

Targeting stereotyped motor behaviors

Group Type EXPERIMENTAL

Transcranial magnetic stimulation

Intervention Type DEVICE

Non-invasive brain stimulation technique that is FDA-approved for the treatment of refractory depression, OCD and migraine.

Interventions

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Transcranial magnetic stimulation

Non-invasive brain stimulation technique that is FDA-approved for the treatment of refractory depression, OCD and migraine.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of Autism Spectrum Disorder (ASD)
2. Meet criteria for Autism Spectrum Disorder (ASD) on clinical assessments (ADOS-2 or CARS if conducted remotely \& ADI-R)
3. Aged between 12-45 years old
4. Have a reliable informant who can complete relevant questionnaires
5. Have DARB scores which indicate high levels (50% or above) of RRB on one of the following domains: Insistence on Sameness, Obsessive Compulsive Behaviors, and Unusual Interests

Exclusion Criteria

1. Any contraindications for TMS e.g. history of seizures other than clear substance-induced/fever-induced seizures with neurologist note or normal clean EEG and no seizure in at least 12 months prior to enrollment.
2. Pregnancy.
3. Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
4. Active substance use (\<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines.
5. Showing symptoms of withdrawal from alcohol or benzodiazepines.
6. DSM-5 diagnosis of bipolar disorder or a psychotic disorder e.g. schizophrenia.
7. Significant sensory impairments such as blindness or deafness.
8. Current severe insomnia (must sleep a minimum of 4 hours the night before stimulation).
9. Not willing to cooperate with the TMS procedures.
10. Currently taking Clozapine or another medication that the PI determines increases the risk of TMS or may disrupt the efficacy.
11. A motor threshold that is too high to allow safe/tolerable treatment.
12. Conditions that increase the risk for COVID-19 (in accordance with university guidelines).
Minimum Eligible Age

12 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Antonio Hardan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Y. Hardan, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Briana Hernandez

Role: CONTACT

(650) 736-1235

Facility Contacts

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Ryan Villacrucis

Role: primary

(650) 736-1235

References

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Barahona-Correa JB, Velosa A, Chainho A, Lopes R, Oliveira-Maia AJ. Repetitive Transcranial Magnetic Stimulation for Treatment of Autism Spectrum Disorder: A Systematic Review and Meta-Analysis. Front Integr Neurosci. 2018 Jul 9;12:27. doi: 10.3389/fnint.2018.00027. eCollection 2018.

Reference Type BACKGROUND
PMID: 30038561 (View on PubMed)

Oberman LM, Rotenberg A, Pascual-Leone A. Use of transcranial magnetic stimulation in autism spectrum disorders. J Autism Dev Disord. 2015 Feb;45(2):524-36. doi: 10.1007/s10803-013-1960-2.

Reference Type BACKGROUND
PMID: 24127165 (View on PubMed)

Other Identifiers

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IRB-57738

Identifier Type: -

Identifier Source: org_study_id

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