Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD

NCT04532424 | Recruiting FDA Device

• 1 other identifier: IRB-57738
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Autism Spectrum Disorder; Autism; Asperger Syndrome

Outcome Measures

Primary Outcomes (1)

• Repetitive Behavior Scale-Revised (RBS-R)

  44-item parent-report questionnaire to measure restricted and repetitive behavior in ASD. We predict that each TMS target will selectively reduce the subscale being targeted.

  Up to one month post-treatment

Secondary Outcomes (1)

• Set-shifting performance (Dimensional Change Card Sort Test score)

  Baseline & immediately after treatment

Study Arms (2)

Targeting insistence on sameness

EXPERIMENTAL

Device: Transcranial magnetic stimulation

Targeting stereotyped motor behaviors

EXPERIMENTAL

Device: Transcranial magnetic stimulation

Interventions

Transcranial magnetic stimulation DEVICE

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

Targeting insistence on sameness; Targeting stereotyped motor behaviors

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of Autism Spectrum Disorder (ASD)
• Meet criteria for Autism Spectrum Disorder (ASD) on clinical assessments (ADOS-2 or CARS if conducted remotely \& ADI-R)
• Aged between 12-45 years old
• Have a reliable informant who can complete relevant questionnaires
• 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

You may not qualify if:

• 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.
• Pregnancy.
• 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.
• Active substance use (\<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines.
• Showing symptoms of withdrawal from alcohol or benzodiazepines.
• DSM-5 diagnosis of bipolar disorder or a psychotic disorder e.g. schizophrenia.
• Significant sensory impairments such as blindness or deafness.
• Current severe insomnia (must sleep a minimum of 4 hours the night before stimulation).
• Not willing to cooperate with the TMS procedures.
• Currently taking Clozapine or another medication that the PI determines increases the risk of TMS or may disrupt the efficacy.
• A motor threshold that is too high to allow safe/tolerable treatment.
• Conditions that increase the risk for COVID-19 (in accordance with university guidelines).

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305-5719, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 30038561 BACKGROUND

• 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.

  PMID: 24127165 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Asperger Syndrome

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Antonio Y. Hardan, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Briana Hernandez

CONTACT

(650) 736-1235; autismdd@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be assigned to one of 2 groups based on the presentation of restricted and repetitive behavior.

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 31, 2020
• Study Start: January 4, 2021
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)