The Therapeutic Effect of TBS Stimulation on Emotion Regulation in Autism Spectrum Disorder

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Device: intermittent theta burst stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04987541

202002498A0

Details and patient eligibility

About

The investigator would like to investigate the impact of intermittent theta burst stimulation over left dorsolateral prefrontal cortex on emotion regulation 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 ADOS

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
• Individuals with a family history of epilepsy
• Previous febrile seizures
• Current taking antiepileptic drugs
• Concurrent use of medications which increased the risk of seizure attack
• Individuals suffering from sleep deprivation during rTMS procedures
• Skin trauma on application site
• Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to participate in the study
• Participate another clinical trial within one month

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 real intervention of TBS (iTBS 600) over the left dorsolateral prefrontal cortex 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 TBS (sham-coil) over the left dorsolateral prefrontal cortex for 4 weeks (5 days/week).

Treatment:

Device: intermittent theta burst stimulation