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

Trial ID or NCT#

NCT04316338

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 22 Years to 55 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 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:
  1. (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.
  2. (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).
  3. (k) History of alcoholism or substance abuse. (l) Active medical problems such as unstable seizures, congenital heart disease, endocrine disorders.
  4. (m) Significant sensory impairments such as blindness or deafness. (n) Contraindication for MRI. (o) Pregnancy. (p) evidence of genetic syndrome.
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Investigator(s)

Lawrence Fung MD PhD
Lawrence Fung MD PhD
Psychiatrist
Associate Professor of Psychiatry and Behavioral Sciences (Major Laboratories & Clinical Translational Neurosciences Incubator)

Contact us to find out if this trial is right for you.

Contact

Eleanor Cole, PhD
4157247960

View on ClinicalTrials.gov