Theta burst stimulation to the right inferior frontal gyrus for autism
Explore the Impacts of Theta Burst Stimulation Over the Right Inferior Frontal Gyrus in Autism Spectrum Disorder: Combination of Clinical Symptoms, Neuropsychological Function and MRI
This study will try intermittent theta burst stimulation over the right inferior frontal gyrus to see if it improves core autism symptoms and thinking and daily living skills in people aged 8-30 with ASD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 8 Years to 30 Years |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Locations | 1 site (Taoyuan) |
| Trial ID | NCT07579494 on ClinicalTrials.gov |
What this trial studies
Participants aged 8-30 with DSM-5 ASD level 1 or 2 confirmed by ADOS-2 will receive intermittent theta burst stimulation (iTBS) targeted to the right inferior frontal gyrus. Clinical symptom ratings, adaptive functioning measures, neuropsychological tests, and MRI-based neurophysiological signals will be collected before and after the iTBS course to detect changes. The protocol requires stable treatment regimens or documented treatment nonresponse/decline and capacity to consent (UBACC ≥15). Key exclusions include epilepsy, severe systemic or neurological disease, significant brain injury, and implanted metallic devices.
Who should consider this trial
Good fit: Ideal participants are people aged 8-30 with ASD (DSM-5 level 1 or 2) who pass the UBACC capacity screen, are on stable treatments or have declined conventional options, and have no contraindicating medical conditions or metal implants.
Not a fit: People with severe epilepsy, major cardiovascular or systemic disease, significant brain injury, implanted pacemakers or medication pumps, those with DSM-5 level 3 ASD, or those outside the 8-30 age range are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, the treatment could reduce core autism symptoms and improve cognitive and adaptive functioning without adding medications.
How similar studies have performed: Preliminary TMS/TBS studies in autism and related disorders have shown mixed but occasionally promising results in small samples, so the approach remains experimental.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants aged 8 to 30 years with a clinical diagnosis of Autism Spectrum Disorder (ASD), confirmed by the ADOS-2 (Autism Diagnostic Observation Schedule, Second Edition). * DSM-5 severity level of ASD: level 1 or level 2 * Participants who have been on a stable treatment regimen prior to the study, or those for whom conventional treatments have been assessed as ineffective by a physician, or those who decline conventional treatment. * A score of ≥ 15 on the University of California Brief Assessment of Capacity to Consent (UBACC) and demonstrated understanding of study aims and risks via the teach-back method. Exclusion Criteria: * Previous or current severe neurological disorders, especially epilepsy, visual or auditory impairments * 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 or substance abuse * Pregnancy * Presence of significant brain abnormalities, such as intracranial space-occupying 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 * Current major depressive disorder * Suicidal ideation within one year * Currently taking tricyclic antidepressants (TCAs), analgesics, or any medications known to lower the seizure threshold. 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 * Changes in the frequency or dosage of concurrent treatments during the 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.