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

NCT ID: NCT07114770

Last Updated: 2025-08-11

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

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-29

Study Completion Date

2028-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Autism Spectrum Disorder Theta Burst Stimulation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Autistic adults

Eligible participants are adults diagnosed with autism who meet the inclusion criteria of the study.

Group Type EXPERIMENTAL

Theta Burst Stimulation (TBS, an advanced variant of repetitive transcranial magnetic stimulation)

Intervention Type DEVICE

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.

Typically developing adults

Eligible participants are typically developing adults who meet the study's inclusion criteria.

Group Type ACTIVE_COMPARATOR

Theta Burst Stimulation (TBS, an advanced variant of repetitive transcranial magnetic stimulation)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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


* ≥18 years old without autism spectrum disorder

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Health Research Institutes, Taiwan

OTHER

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hsing-Chang Ni, Ph.D

Role: CONTACT

88633281200 ext. 2479

Facility Contacts

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Hsing Chang Ni, Ph.D

Role: primary

886-3-3281200 ext. 2479

Other Identifiers

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202500396A0

Identifier Type: -

Identifier Source: org_study_id

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