Explore the Impacts of One Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

Official title:

Explore the Impacts of One Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05578261
• Other study ID #: 202200409A0
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 28, 2022
• Est. completion date: December 2023

Study information

• Verified date: August 2023
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigator would like to investigate the impact of theta-burst stimulation over cerebellum in adults with autism spectrum disorder

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults with autism spectrum disorder (=18 years old), confirmed by Autism Diagnostic Observation Schedule.

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
• Concurrent use of medications which increased the risk of seizure attack
• Participate another clinical trial within one month
• Skin trauma on application site
• Individuals suffering from multiple sclerosis
• Individuals with a large ischemic scar
• Individuals suffering from sleep deprivation during rTMS procedures
• Individuals with a heavy consumption of alcohol
• Current taking antiepileptic drugs
• Individuals with a migraine headache from increased intracranial pressure
• Unable to complete MRI scan

Withdrawal criteria:

• Seizure attack during study period
• Autistic symptoms worsened obviously during study period
• Extreme agitation or irritability during study period
• Participants request
• Take antiepileptic drug during study period

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Device:
• intermittent theta burst stimulation
stimulatory protocol

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse effects report form (Headache)	Recording adverse effects in participants after iTBS.	1 week after iTBS (post iTBS)
Primary	Adverse effects report form (Dizziness)	Recording adverse effects in participants after iTBS.	1 week after iTBS (post iTBS)
Primary	Adverse effects report form (Tinnitus)	Recording adverse effects in participants after iTBS.	1 week after iTBS (post iTBS)
Primary	Adverse effects report form (Seizure)	Recording adverse effects in participants after iTBS.	1 week after iTBS (post iTBS)
Primary	Adverse effects report form (Other)	Recording adverse effects in participants after iTBS.	1 week after iTBS (post iTBS)
Secondary	MRI T1	Brain structural volumes (cm²)	Within one month
Secondary	functional MRI (resting-state/biological motion task) - BOLD signal	Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.	Within one month