Therapeutic Impacts of Theta Burst Stimulation Over Bilateral Posterior Superior Temporal Sulcus in Autism Spectrum Disorder

Chang Gung Medical Foundation

Status: Active, not recruiting

Conditions: Autism Spectrum Disorder

Treatments: Device: intermittent theta burst stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05578209

202102232A0

Details and patient eligibility

About

The investigator would like to investigate the impact of intermittent theta burst stimulation over bilateral posterior superior temporal sulcus in autism spectrum disorder

Enrollment: 60 estimated patients

Sex: All

Ages: 8 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Autism spectrum disorder, confirmed by Autism Diagnostic Observation Schedule II (CSS≧6)
• No change in psychiatric drugs within one month

Exclusion criteria

• Previous or current severe neurological disorder such as epilepsy, visual or hearing impairment
• Previous or current severe systemic disease such as cardiovascular disease, diabetes or infection
• Previous or current severe brain injury
• Implementation of metal materials such as pacemaker or medication pump
• Previous or current severe psychiatric disorders such as schizophrenia, bipolar disorder or substance abuse
• Pregnancy
• Individuals with a significant brain abnormality such as intracranial space occupied lesions
• History of brain surgery or nervous system infection, such as meningitis and encephalitis
• Previous febrile seizures
• Concurrent use of medications which increased the risk of seizure attack.
• Participate another clinical trial within one month.
• Unable to complete MRI scan (claustrophobia)
• Skin trauma on application site
• Individuals with a large ischemic scar
• Individuals suffering from multiple sclerosis
• Individuals suffering from sleep deprivation during rTMS procedures
• Individuals with a heavy consumption of alcohol
• Individuals with a migraine headache from increased intracranial pressure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Active

Experimental group

Description:

Participants received the intervention of iTBS (The total pulse of every session is 1200 pulses) over bilateral posterior superior temporal sulcus for 4 weeks (5 days/week). \*iTBS = intermittent theta burst stimulation

Treatment:

Device: intermittent theta burst stimulation

Sham

Sham Comparator group

Description:

Participants received the sham intervention of iTBS (sham-coil) over bilateral posterior superior temporal sulcus for 4 weeks (5 days/week).

Treatment:

Device: intermittent theta burst stimulation