Intermittent Theta-Burst Stimulation to Target Irritability in Adults With ASD

Stanford University

Status: Withdrawn

Conditions: Autism Spectrum Disorder

Treatments: Device: Intermittent theta-burst stimulation (iTBS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04316338

IRB-41458

Details and patient eligibility

About

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 with ASD in reducing irritability in adults with ASD.

Sex: All

Ages: 22 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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)
2. Age 22 to 55.
3. Adults who are physically healthy.
4. No significant current psychosocial stressors per history.
5. Full scale IQ > 50.
6. ABC-I score of 18 or greater.
7. 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 criteria

(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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Active intermittent theta-burst stimulation (iTBS)

Experimental group

Description:

6 weeks of iTBS delivered at 80% resting motor threshold will be delivered to personalized regions in the prefrontal cortex based on each individual's functional connectivity.

Treatment:

Device: Intermittent theta-burst stimulation (iTBS)