Status:
WITHDRAWN
Intermittent Theta-Burst Stimulation to Target Irritability in Adults With ASD
Lead Sponsor:
Stanford University
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
22-55 years
Phase:
NA
Brief Summary
This study aims to demonstrate the feasibility, tolerability, safety and preliminary efficacy of 6 weeks of fMRI-guided iTBS delivered to personalized regions of the prefrontal cortex (PFC) in adults ...
Eligibility Criteria
Inclusion
- Diagnosis of ASD or Asperger's based on DSM-5 criteria as confirmed by a qualified clinician (including Dr. Fung), and if necessary the administration of Autism Diagnostic Interview-Revised (ADI-R) and/or Autism Diagnostic Observation Schedule-Generic (ADOS-G)
- Age 22 to 55.
- Adults who are physically healthy.
- No significant current psychosocial stressors per history.
- Full scale IQ \> 50.
- ABC-I score of 18 or greater.
- if the participant is taking medication, they must be stable on this medication regiment for at least 4 weeks prior to baseline and agree to stay on these medications for the duration of the trial
Exclusion
- (f) Pre-term birth (\<34 weeks' gestation) (g) Low birth weight (\<2000 g). (h) DSM-5 diagnosis of other severe psychiatric disorder such as bipolar disorder or schizophrenia.
- (i) Current use of benzodiazepines. (j) Use of other medications that modulate the GABA(A) receptor within 4 weeks of scanning (8 weeks for fluoxetine).
- (k) History of alcoholism or substance abuse. (l) Active medical problems such as unstable seizures, congenital heart disease, endocrine disorders.
- (m) Significant sensory impairments such as blindness or deafness. (n) Contraindication for MRI. (o) Pregnancy. (p) evidence of genetic syndrome.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04316338
Start Date
May 1 2022
End Date
May 1 2025
Last Update
November 28 2023
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