- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04316338
Intermittent Theta-Burst Stimulation to Target Irritability in Adults With ASD
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eleanor Cole, PhD
- Phone Number: 4157247960
- Email: ecole@stanford.edu
Study Contact Backup
- Name: Lawrence Fung, MD, PhD
- Phone Number: 6504989392
- Email: lkfung@stanford.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active intermittent theta-burst stimulation (iTBS)
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.
|
Non-invasive brain stimulation technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aberrant Behavior Checklist-irritability subscale (ABC-I)
Time Frame: Change across time: Baseline minus immediately after final treatment
|
A parent/caregiver/clinician completed checklist (58-item) with an irritability subscale (15-item).
Each item has a maximum score of 3, meaning that the irritability subscale has a maximum score of 45 and minimum score of 0. Higher scores indicate higher levels of irritability.
|
Change across time: Baseline minus immediately after final treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Irritability Questionnaire
Time Frame: Baseline, every week of treatment (1-6), immediately after treatment, one month after treatment.
|
A 21-item self-report measure of irritability.
Each item is rated on how often (Never=0 to Most of the time=4) and the intensity (Not at all=0, Very much so=4) at which they occur.
|
Baseline, every week of treatment (1-6), immediately after treatment, one month after treatment.
|
Self-injury questionnaire (SIQ)
Time Frame: Baseline, immediately after treatment, one month after treatment.
|
Self-report measure of self-injury, maximum 60 questions but participants only answer relevant questions.
Five types of self-injurious behaviors are checked: scratching, bruising, cutting, burning, and biting oneself.
It will assess the taxonomic specifications of self-injurious behavior (SIB- (e.g., type, frequency, duration)), but also the affective antecedents and consequences as well as the functions of each type of SIB.
|
Baseline, immediately after treatment, one month after treatment.
|
THE MODIFIED OVERT AGGRESSION SCALE (MOAS)
Time Frame: Baseline, immediately after treatment, one month after treatment.
|
Clinician rated scale of aggression. 4 items rated from 0-4.
Maximum score is 16 with higher scores indicating higher levels of aggression, used to evaluate and document the "frequency and severity" of aggressive episodes.
|
Baseline, immediately after treatment, one month after treatment.
|
Difficulties in Emotion Regulation Scale
Time Frame: Baseline, immediately after treatment, one month after treatment.
|
Self-report measure of emotion regulation, evaluating individuals' levels of difficulties in regulating emotions.
36-item questionnaires.
Each question rated from 1-5.
Maximum score is 180 with higher scores indicating greater difficulty in emotion regulation.
The instrument presents 36 items on a 5-point Likert scale of frequency (from 1 = almost never, to 5 = almost always).
|
Baseline, immediately after treatment, one month after treatment.
|
The Adult Autism Quotient (AQ)
Time Frame: Baseline, immediately after treatment, one month after treatment.
|
50-item self-report measure of autistic traits.
Each of 50 statements are rated from 'definitely disagree' to 'definitely agree'.
|
Baseline, immediately after treatment, one month after treatment.
|
Repetitive Behavior Scale-Revised (RBS-R)
Time Frame: Baseline, immediately after treatment, one month after treatment.
|
43-item clinician rated scale measuring repetitive behaviors associated with ASD.
Each item is rated from 0 (behavior does not occur) to 3 (behavior is a severe problem)
|
Baseline, immediately after treatment, one month after treatment.
|
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: Baseline, immediately after treatment, one month after treatment.
|
10-item clinician rated measure of depressive symptoms.
Each item is rated on a scale of 1-6.
|
Baseline, immediately after treatment, one month after treatment.
|
Functional connectivity between areas involved in negative emotion regulation
Time Frame: Baseline, immediately after treatment, one month after treatment.
|
Functional magnetic resonance imaging (fMRI) will be used to measure functional connectivity between areas involved in emotion regulation, previously shown to be involved in irritability.
Areas of interest include: ventromedial prefrontal cortex, the amygdala, dorsolateral prefrontal cortex, the striatum.
|
Baseline, immediately after treatment, one month after treatment.
|
EEG recordings
Time Frame: Baseline, immediately after treatment, one month after treatment.
|
Electroencephalography (EEG) will be used to measure brain activity and connectivity before and after treatment.
Resting-state EEG (5 minutes) with eyes open and TMS-evoked potential recordings will be taken before and after treatment.
We are particularly interested in measuring gamma band activity (>30Hz) in participants while at rest.
|
Baseline, immediately after treatment, one month after treatment.
|
Magnetic resonance spectroscopy (MRS)
Time Frame: Baseline, immediately after treatment, one month after treatment.
|
MRS will be used to measure GABA levels in two brain areas of interest (ventromedial prefrontal cortex and amygdala) before and after treatment.
|
Baseline, immediately after treatment, one month after treatment.
|
Aberrant Behavior Checklist-irritability subscale (ABC-I)
Time Frame: Change across time: Baseline minus one month after treatment
|
A parent/caregiver/clinician completed checklist (58-item) with an irritability subscale (15-item).
Each item has a maximum score of 3, meaning that the irritability subscale has a maximum score of 45 and minimum score of 0. Higher scores indicate higher levels of irritability.
|
Change across time: Baseline minus one month after treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lawrence Fung, MD, PhD, Stanford University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-41458
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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