Recruiting NCT04532424

Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD

No phase Interventional Autism Spectrum Disorder Autism Asperger Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Transcranial magnetic stimulation.
Who it may be relevant to: Registry conditions: Autism Spectrum Disorder, Autism, Asperger Syndrome. Basic parameters: 12 years — 45 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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

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

Repetitive Behavior Scale-Revised (RBS-R) [Time frame: Up to one month post-treatment]

Secondary outcome measures (1)

Set-shifting performance (Dimensional Change Card Sort Test score) [Time frame: Baseline & immediately after treatment]

Inclusion criteria.

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

Exclusion criteria.

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 1 center

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
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

NCT: NCT04532424 · IRB-57738