Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD

Autism Spectrum Disorder Clinical Trial

— TMS for ASD  

Official title:

Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04532424
• Other study ID #: IRB-57738
• Status: Suspended
• Phase: N/A
• Start date: January 4, 2021
• Est. completion date: March 1, 2025

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 67
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asperger Syndrome
• Autism
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Robin Libove	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Set-shifting performance (Dimensional Change Card Sort Test score)	The Dimensional Change Card Sort Test one of the cognitive measures from the NIH toolbox. These measures are administered on an iPad. The test takes 4 minutes to complete.	Baseline & immediately after treatment