Clinical trial NCT04316338: Intermittent Theta-Burst Stimulation to Target Irritability in Adults With ASD
Official title: Intermittent Theta-Burst Stimulation to Target Irritability in Adults With ASD
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-03-20
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label design.
Primary purpose: TREATMENT

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 with ASD in reducing irritability in adults with ASD.


Eligibility criteria: 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.

Primary outcomes:
measure: Aberrant Behavior Checklist-irritability subscale (ABC-I)
timeFrame: Change across time: Baseline minus immediately after final treatment
Secondary outcomes:
measure: Irritability Questionnaire
timeFrame: Baseline, every week of treatment (1-6), immediately after treatment, one month after treatment.
measure: Self-injury questionnaire (SIQ)
timeFrame: Baseline, immediately after treatment, one month after treatment.
measure: THE MODIFIED OVERT AGGRESSION SCALE (MOAS)
timeFrame: Baseline, immediately after treatment, one month after treatment.
measure: Difficulties in Emotion Regulation Scale
timeFrame: Baseline, immediately after treatment, one month after treatment.
measure: The Adult Autism Quotient (AQ)
timeFrame: Baseline, immediately after treatment, one month after treatment.
measure: Repetitive Behavior Scale-Revised (RBS-R)
timeFrame: Baseline, immediately after treatment, one month after treatment.
measure: Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: Baseline, immediately after treatment, one month after treatment.
measure: Functional connectivity between areas involved in negative emotion regulation
timeFrame: Baseline, immediately after treatment, one month after treatment.
measure: EEG recordings
timeFrame: Baseline, immediately after treatment, one month after treatment.
measure: Magnetic resonance spectroscopy (MRS)
timeFrame: Baseline, immediately after treatment, one month after treatment.
measure: Aberrant Behavior Checklist-irritability subscale (ABC-I)
timeFrame: Change across time: Baseline minus one month after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Lawrence Fung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: