Theta burst stimulation to the right inferior frontal gyrus for autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Chang Gung Memorial Hospital
  Taoyuan, Taiwan Recruiting

Study contacts

• Study coordinator: Hsing-Chang Ni, Ph.D
• Email: alanni0918@yahoo.com.tw
• Phone: 88633281200

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• One-session versus multiple-session theta burst stimulation over the cerebellum in adults with autism

  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.

  Recruiting Chang Gung Memorial Hospital · Taoyuan · NCT07114770

• Sensory Integration and Deep Pressure Therapy for Motor Coordination in Children with ASD

  This study tests whether combining Sensory Integration Therapy with Deep Pressure Therapy can improve motor coordination and reduce repetitive behaviors in children aged 4–10 with autism.

  Recruiting Riphah International University · Rawalpindi, Punjab Province · NCT07911904

• Pupillometer screen to help identify autism in kids aged 2–4 during routine visits

  A handheld pupillometer test is being tried to see if it can help identify autism in young children during regular pediatric visits.

  Recruiting at 4 sites Schweitzer Engineering Laboratories · Lewiston, Idaho and 3 other locations · NCT07903675

• Leopard: using multi-omics to boost genetic diagnosis for neurodevelopmental disorders

  This study tests a multi-omics approach to find genetic explanations for neurodevelopmental disorders in people with moderate-to-severe intellectual disability.

  Recruiting Istituto Giannina Gaslini · Genova · NCT07884227

• iTBS to help anhedonia in depression (dual left DLPFC + OFC or left DLPFC alone)

  A brain stimulation study tests whether intermittent theta burst stimulation can help people with major depression who have anhedonia, using both dual-target (left DLPFC and OFC) and single-target (left DLPFC) approaches.

  Recruiting Central South University · Changsha, Hunan · NCT07813169

• Heart Rate Variability Biofeedback for Anxiety in Autistic Youth

  This study tests a wearable heart rate variability biofeedback tool to see if it helps reduce anxiety in autistic teens.

  Recruiting Phase 2 Massachusetts General Hospital · Lexington, Massachusetts · NCT07812233

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.