Clinical trial NCT04532424: Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD
Official title: Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Autism
Asperger Syndrome
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 67
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to one of 2 groups based on the presentation of restricted and repetitive behavior.
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Autism Spectrum Disorder (ASD), Asperger's or Autism.
2. Meet criteria for ASD on clinical assessments (ADOS-2 or CARS/BOSA if conducted remotely \& ADI-R)
3. Aged between 12-45 years old
4. Have a reliable informant who can complete relevant questionnaires
5. Must have previously not responded or not tolerated 2 treatments.

Exclusion Criteria:

1. Any contraindications for TMS e.g. history of seizures
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. Any other indication the PI feels would comprise data
9. Current severe insomnia (must sleep a minimum of 4 hours the night before stimulation)
10. IQ\<50 or not testable using IQ measures and no historical IQ score available
11. Currently taking Clozapine or another medication that the PI determines increases the risk of TMS or may disrupt the efficacy.
12. A motor threshold that is too high to allow safe/tolerable treatment.

Primary outcomes:
measure: Repetitive Behavior Scale-Revised (RBS-R)
timeFrame: Up to one month post-treatment
Secondary outcomes:
measure: Set-shifting performance (Dimensional Change Card Sort Test score)
timeFrame: Baseline & immediately after treatment
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Antonio Y. Hardan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.