Autism Spectrum Disorder, Theta Burst Stimulation
Conditions
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).
Interventions
DEVICETheta Burst Stimulation (TBS, an advanced variant of repetitive transcranial magnetic stimulation)
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.
Sponsors
National Health Research Institutes, Taiwan
Chang Gung Memorial Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional MRI (default mode network) - BOLD Signal | Baseline, Week 1, Week 2 | Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity. |
| MEP amplitude | Baseline | MEP (motor evoked potential) amplitude is a measure of corticospinal excitability. |
Countries
Taiwan
Contacts
Primary ContactHsing-Chang Ni, Ph.D
Outcome results
None listed