NCT07114770

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
33mo left

Started Jul 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Jul 2025Dec 2028

Study Start

First participant enrolled

July 29, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

2.9 years

First QC Date

August 4, 2025

Last Update Submit

August 8, 2025

Conditions

Autism Spectrum DisorderTheta Burst Stimulation

Outcome Measures

Primary Outcomes (10)

  • Functional MRI (default mode network) - BOLD Signal

    Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.

    Baseline, Week 1, Week 2

  • MEP amplitude

    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.

    Baseline

  • MEP amplitude

    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.

    Week 1 (5 minutes post-TBS)

  • MEP amplitude

    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.

    Week 2 (5 minutes post-TBS)

  • MEP amplitude

    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.

    Week 1 (10 minutes post-TBS)

  • MEP amplitude

    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.

    Week 2 (10 minutes post-TBS)

  • MEP amplitude

    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.

    Week 1 (15 minutes post-TBS)

  • MEP amplitude

    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.

    Week 2 (15 minutes post-TBS)

  • MEP amplitude

    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.

    Week 1 (20 minutes post-TBS)

  • MEP amplitude

    MEP (motor evoked potential) amplitude is a measure of corticospinal excitability.

    Week 2 (20 minutes post-TBS)

Study Arms (2)

Autistic adults

EXPERIMENTAL

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

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

Typically developing adults

ACTIVE COMPARATOR

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

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

Interventions

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

Autistic adultsTypically developing adults

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Hsing-Chang Ni, Ph.D

CONTACT

88633281200alanni0918@yahoo.com.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2025

First Posted

August 11, 2025

Study Start

July 29, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

August 11, 2025

Record last verified: 2025-08

Locations

TW(1)