Autism Spectrum Disorder, Right Inferior Frontal Gyrus, Theta Burst Stimulation
Conditions
Brief summary
Exploring the therapeutic efficacy of Theta Burst Stimulation (TBS) over the right inferior frontal gyrus (RIFG) in autism, including changes in core symptoms, adaptive functioning, neuropsychological performance, and neurophysiological signals.
Interventions
DEVICEintermittent theta burst stimulation
stimulatory protocol
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 30 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of total scores of Social Responsiveness Scale | baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) | Social Responsiveness Scale can measure the autism clinical severity with the range from 65-260. The lower scores stand for better social responsiveness. |
| Changes of total scores of Repetitive Behavior Scale-Revised | baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) | Repetitive Behavior Scale-Revised is a questionnaire that focuses on repetitive behavior. The score ranges from 0-129. The lower scores stand for lower repetitive behavior. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of total scores of Emotional Dysregulation Inventory | baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) | Emotional Dysregulation Inventory is a parents' report questionnaire for emotional dysregulation. The score ranges from 0-120. The lower scores stand for better emotional regulation. |
| Changes of total scores of Child Behavior Checklist | baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) | CBCL is a parents' report questionnaire for behavioral and emotional problems. The lower scores stand for better behavioral and emotional regulation. |
| Changes of total scores of Anxiety Scale for Autism | baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) | ASA is a parents' report questionnaire for severity of anxiety in children with ASD. The score ranges from 0-72. The lower scores stand for better emotional regulation. |
| Changes of total scores of Adaptive Behavior Assessment System | baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) | Adaptive Behavior Assessment System is a parents' report questionnaire for adaptive behavior. The score ranges from 40-120. The higher scores stand for better adaptive behavior. |
| Accuracy of Frith-Happe Animation | baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) | A quick and objective test of Theory of Mind. 8 questions in total, the more correct questions stand for better social cognition. |
| Accuracy of Eyes Task | baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) | An advanced test for Theory of Mind. 43 questions in total, the more correct questions stand for better social skills. |
| Accuracy of Wisconsin Card Sorting Test | baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) | An advanced test for cognitive flexibility. 128 questions in total, the more correct questions stand for better cognitive flexibility. |
| Changes of total scores of Behavior Rating Inventory of Executive Function | baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) | Behavior Rating Inventory of Executive Function is a parents' report questionnaire for executive function. The score ranges from 20-110. The lower scores stand for better executive function. |
| Raven's Progressive Matrices | baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) | An advanced test for for executive function. 60 questions in total, the more correct questions stand for better executive function. |
Countries
Taiwan
Contacts
CONTACTHsing-Chang Ni, Ph.D
Outcome results
None listed