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Recruiting NCT07114770

Explore the Impacts of One Session and Multiple Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder

No phase Interventional Autism Spectrum Disorder Theta Burst Stimulation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Theta Burst Stimulation (TBS, an advanced variant of repetitive transcranial magnetic stimulation).
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder, Theta Burst Stimulation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This study aims to establish a personalized theta burst stimulation (TBS, an advanced variant of repetitive transcranial magnetic stimulation, rTMS) protocol considering autistic idiosyncrasy (interindividual variability).

Interventions

  • Device Theta Burst Stimulation (TBS, an advanced variant of repetitive transcranial magnetic stimulation)
    Participants will receive a single session of either iTBS or cTBS (600 pulses) targeting the right cerebellar Crus I/II. One week after the initial TBS, they will receive another single session of iTBS or cTBS (600 pulses) at the same site.

Primary outcome measures

  • Functional MRI (default mode network) - BOLD Signal [Time frame: Baseline, Week 1, Week 2]
  • MEP amplitude [Time frame: Baseline]
  • MEP amplitude [Time frame: Week 1 (5 minutes post-TBS)]
  • MEP amplitude [Time frame: Week 2 (5 minutes post-TBS)]
  • MEP amplitude [Time frame: Week 1 (10 minutes post-TBS)]
  • MEP amplitude [Time frame: Week 2 (10 minutes post-TBS)]
  • MEP amplitude [Time frame: Week 1 (15 minutes post-TBS)]
  • MEP amplitude [Time frame: Week 2 (15 minutes post-TBS)]
  • MEP amplitude [Time frame: Week 1 (20 minutes post-TBS)]
  • MEP amplitude [Time frame: Week 2 (20 minutes post-TBS)]

Eligibility criteria

Inclusion criteria for autistic adults:

  • Autistic adults (≥18 years old), confirmed by Autism Diagnostic Observation Schedule.
  • DSM-5 severity level of ASD: level 1 or level 2

Inclusion criteria for typically developing control:

  • ≥18 years old without autism spectrum disorder

Exclusion criteria for all participants:

  • Previous or current severe neurological disorders, especially epilepsy
  • Previous or current severe systemic diseases such as cardiovascular disease, diabetes or hypertension
  • Previous or current severe brain injury
  • Implementation of metal materials such as a pacemaker or medication pump
  • Previous or current severe psychiatric disorders such as schizophrenia, bipolar disorder, severe major depressive disorder or substance abuse
  • Pregnancy
  • Intracranial space occupied lesions
  • Previous brain surgery or central nerve system infection
  • Concurrent use of medications which increased the risk of seizure attack
  • Participate in another clinical trial within one month
  • With damaged skin at the stimulated region
  • With multiple sclerosis
  • With large ischemic scars
  • Have experienced sleep disorders during brain stimulation
  • Severe alcoholism
  • Concurrent use of antiepileptic drugs
  • Uncontrollable migraines due to increased intracranial pressure
  • Unsuitable for MRI (e.g. those with claustrophobia)
  • Unsuitable for EEG
  • DSM-5 severity level of ASD: level 3
  • Suicidal ideation within one year

Withdrawal criteria:

  • Seizure attack during the study period
  • Autistic symptoms worsened obviously during the study period (change of DSM-5 severity level)
  • Extreme agitation or irritability during the study period
  • Participants request
  • Clinical symptoms worsened obviously during study period
  • Start to use antiepileptic drugs during study period
  • Suicidal ideation or self-harm behaviors during study period

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

Taiwan · 1 center
  • Chang Gung Memorial Hospital — Taoyuan

Identifiers

NCT: NCT07114770 · 202500396A0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗