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

NCT ID: NCT04316338

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2025-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open-label design.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Intermittent theta-burst stimulation (iTBS)

Intervention Type DEVICE

Non-invasive brain stimulation technique

Interventions

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Intermittent theta-burst stimulation (iTBS)

Non-invasive brain stimulation technique

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

22 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Lawrence Fung

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lawrence Fung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Other Identifiers

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IRB-41458

Identifier Type: -

Identifier Source: org_study_id