NCT04316338

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2022

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
2.1 years until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

September 24, 2019

Last Update Submit

November 22, 2023

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change across time: Baseline minus immediately after final treatment

Secondary Outcomes (11)

  • Irritability Questionnaire

    Baseline, every week of treatment (1-6), immediately after treatment, one month after treatment.

  • Self-injury questionnaire (SIQ)

    Baseline, immediately after treatment, one month after treatment.

  • THE MODIFIED OVERT AGGRESSION SCALE (MOAS)

    Baseline, immediately after treatment, one month after treatment.

  • Difficulties in Emotion Regulation Scale

    Baseline, immediately after treatment, one month after treatment.

  • The Adult Autism Quotient (AQ)

    Baseline, immediately after treatment, one month after treatment.

  • +6 more secondary outcomes

Study Arms (1)

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.

Device: Intermittent theta-burst stimulation (iTBS)

Interventions

Intermittent theta-burst stimulation (iTBS)DEVICE

Non-invasive brain stimulation technique

Active intermittent theta-burst stimulation (iTBS)

Eligibility Criteria

Age22 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Lawrence Fung, MD, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open-label design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 24, 2019

First Posted

March 20, 2020

Study Start

May 1, 2022

Primary Completion

May 1, 2024

Study Completion

May 1, 2025

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share