Autism Spectrum DisorderNCT04316338
Intermittent Theta-Burst Stimulation to Target Irritability in Adults With ASD
A study testing Intermittent theta-burst stimulation (iTBS) in people with Autism Spectrum Disorder, run by Stanford University.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 55 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Intermittent theta-burst stimulation (iTBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
- Current use of benzodiazepines. (j) Use of other medications that modulate the GABA(A) receptor within 4 weeks of scanning (8 weeks for fluoxetine).
- History of alcoholism or substance abuse. (l) Active medical problems such as unstable seizures, congenital heart disease, endocrine disorders.
- Significant sensory impairments such as blindness or deafness. (n) Contraindication for MRI. (o) Pregnancy. (p) evidence of genetic syndrome.
About this study
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Intermittent theta-burst stimulation (iTBS)
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent theta-burst stimulation (iTBS)Device
Non-invasive brain stimulation technique
| Study group | Role | What they receive |
|---|---|---|
| Active intermittent theta-burst stimulation (iTBS) | Experimental | 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. Receives: Device: Intermittent theta-burst stimulation (iTBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aberrant Behavior Checklist-irritability subscale (ABC-I)
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.
Measured: Change across time: Baseline minus immediately after final treatment
Secondary outcomes (11)
Irritability Questionnaire
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.
Measured: Baseline, every week of treatment (1-6), immediately after treatment, one month after treatment.
Self-injury questionnaire (SIQ)
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.
Measured: Baseline, immediately after treatment, one month after treatment.
THE MODIFIED OVERT AGGRESSION SCALE (MOAS)
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.
Measured: Baseline, immediately after treatment, one month after treatment.
Difficulties in Emotion Regulation Scale
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).
Measured: Baseline, immediately after treatment, one month after treatment.
The Adult Autism Quotient (AQ)
50-item self-report measure of autistic traits. Each of 50 statements are rated from 'definitely disagree' to 'definitely agree'.
Measured: Baseline, immediately after treatment, one month after treatment.
Repetitive Behavior Scale-Revised (RBS-R)
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)
Measured: Baseline, immediately after treatment, one month after treatment.
Montgomery-Åsberg Depression Rating Scale (MADRS)
10-item clinician rated measure of depressive symptoms. Each item is rated on a scale of 1-6.
Measured: Baseline, immediately after treatment, one month after treatment.
Functional connectivity between areas involved in negative emotion regulation
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.
Measured: Baseline, immediately after treatment, one month after treatment.
EEG recordings
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.
Measured: Baseline, immediately after treatment, one month after treatment.
Magnetic resonance spectroscopy (MRS)
MRS will be used to measure GABA levels in two brain areas of interest (ventromedial prefrontal cortex and amygdala) before and after treatment.
Measured: Baseline, immediately after treatment, one month after treatment.
Aberrant Behavior Checklist-irritability subscale (ABC-I)
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.
Measured: Change across time: Baseline minus one month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start1 May 2022 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2025 (estimated)
Why it stopped: Funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label design.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lawrence Fung, Stanford University
- Investigators
- Lawrence Fung, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316338
- Sponsor's protocol ID
- IRB-41458
- Status last verified
- Nov 2023
- First submitted
- 24 Sep 2019
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Theta-Burst Stimulation to Target Irritability in Adults With ASD
- ClinicalTrials.gov ID
- NCT04316338
- Acronym / sponsor ID
- IRB-41458
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 20 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label design.
| Arm | Type | Receives |
|---|---|---|
| Active intermittent theta-burst stimulation (iTBS) | Experimental | Device: 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. |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
- Current use of benzodiazepines. (j) Use of other medications that modulate the GABA(A) receptor within 4 weeks of scanning (8 weeks for fluoxetine).
- History of alcoholism or substance abuse. (l) Active medical problems such as unstable seizures, congenital heart disease, endocrine disorders.
- Significant sensory impairments such as blindness or deafness. (n) Contraindication for MRI. (o) Pregnancy. (p) evidence of genetic syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent theta-burst stimulation (iTBS)Non-invasive brain stimulation technique | Device | Active intermittent theta-burst stimulation (iTBS) |
Primary outcome
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.
11 secondary outcomes
Irritability Questionnaire
Time frame: 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.
THE MODIFIED OVERT AGGRESSION SCALE (MOAS)
Time frame: Baseline, immediately after treatment, one month after treatment.
Difficulties in Emotion Regulation Scale
Time frame: Baseline, immediately after treatment, one month after treatment.
The Adult Autism Quotient (AQ)
Time frame: Baseline, immediately after treatment, one month after treatment.
Repetitive Behavior Scale-Revised (RBS-R)
Time frame: Baseline, immediately after treatment, one month after treatment.
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 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.
EEG recordings
Time frame: Baseline, immediately after treatment, one month after treatment.
Magnetic resonance spectroscopy (MRS)
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Fung, MD, PhD principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent theta-burst stimulation (iTBS) in people with Autism Spectrum Disorder, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aberrant Behavior Checklist-irritability subscale (ABC-I) (time frame: Change across time: Baseline minus immediately after final treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.