One-session versus multiple-session theta burst stimulation over the cerebellum in adults with autism
Explore the Impacts of One Session and Multiple Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder
NA · Chang Gung Memorial Hospital · NCT07114770
This trial tests whether personalized cerebellar theta burst stimulation given as one session or multiple sessions changes brain activity or symptoms in adults with autism.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital (other) |
| Locations | 1 site (Taoyuan) |
| Trial ID | NCT07114770 on ClinicalTrials.gov |
What this trial studies
Adults with autism (confirmed by ADOS and DSM-5 severity level 1 or 2) and a group of typically developing adults will receive theta burst stimulation (TBS) targeted to the cerebellum. The protocol adapts stimulation parameters to individual neurophysiology to account for autistic idiosyncrasy and compares a single-session regimen to a multiple-session regimen. Participants are screened to exclude conditions that increase seizure risk or contraindicate TBS (for example, epilepsy, metal implants, or severe psychiatric/medical comorbidity). Outcomes will include clinical symptom measures and neurophysiological markers collected before and after stimulation to detect changes over time.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18 years) with an ADOS-confirmed diagnosis of autism and DSM-5 severity level 1 or 2 who do not have contraindicating medical or psychiatric conditions.
Not a fit: People with severe neurological or systemic diseases, a history of epilepsy or seizure risk, metal implants such as pacemakers, pregnancy, level 3 autism, or other excluded comorbidities are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, personalized cerebellar TBS could improve brain function or reduce certain symptoms related to autism in some adults.
How similar studies have performed: Related rTMS/TBS approaches for neuropsychiatric conditions have produced mixed but sometimes promising preliminary results, while cerebellar TBS in autism remains relatively novel and less well established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Taoyuan
- Chang Gung Memorial Hospital — Taoyuan, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Hsing-Chang Ni, Ph.D
- Email: alanni0918@yahoo.com.tw
- Phone: 88633281200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Autism Spectrum Disorder, Theta Burst Stimulation