Health TrialsbyHealthPanel

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

ConditionsAutism Spectrum DisorderTheta Burst Stimulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChang Gung Memorial Hospital

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Autistic adultsExperimental treatment 1 intervention
Group B: Typically developing adultsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Functional MRI (default mode network) - BOLD Signal

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

Time frame
Baseline, Week 1, Week 2
2

MEP amplitude

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

Time frame
Baseline
3

MEP amplitude

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

Time frame
Week 1 (5 minutes post-TBS)
4

MEP amplitude

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

Time frame
Week 2 (5 minutes post-TBS)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chang Gung Memorial Hospital

Lead sponsor

National Health Research Institutes, Taiwan

Collaborator

Source ClinicalTrials.gov
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