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

NCT05578261 | Unknown

• 1 other identifier: 202200409A0
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (5)

• Adverse effects report form (Headache)

  Recording adverse effects in participants after iTBS.

  1 week after iTBS (post iTBS)

• Adverse effects report form (Dizziness)

  Recording adverse effects in participants after iTBS.

  1 week after iTBS (post iTBS)

• Adverse effects report form (Tinnitus)

  Recording adverse effects in participants after iTBS.

  1 week after iTBS (post iTBS)

• Adverse effects report form (Seizure)

  Recording adverse effects in participants after iTBS.

  1 week after iTBS (post iTBS)

• Adverse effects report form (Other)

  Recording adverse effects in participants after iTBS.

  1 week after iTBS (post iTBS)

Secondary Outcomes (2)

• MRI T1

  Within one month

• functional MRI (resting-state/biological motion task) - BOLD signal

  Within one month

Study Arms (1)

Active

EXPERIMENTAL

All of the participants will accept one session iTBS over right Crus I/II. The total pulses of every session are 1200 pulses (600 pulses with 15 minutes interval) \*iTBS = intermittent theta burst stimulation.

Device: intermittent theta burst stimulation

Interventions

intermittent theta burst stimulation DEVICE

stimulatory protocol

Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 13, 2022
• Study Start: December 28, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Locations

TW (1)