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

August 29, 2023 updated by: Chang Gung Memorial Hospital
The investigator would like to investigate the impact of theta-burst stimulation over cerebellum in adults with autism spectrum disorder

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active

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
stimulatory protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects report form (Headache)
Time Frame: 1 week after iTBS (post iTBS)
Recording adverse effects in participants after iTBS.
1 week after iTBS (post iTBS)
Adverse effects report form (Dizziness)
Time Frame: 1 week after iTBS (post iTBS)
Recording adverse effects in participants after iTBS.
1 week after iTBS (post iTBS)
Adverse effects report form (Tinnitus)
Time Frame: 1 week after iTBS (post iTBS)
Recording adverse effects in participants after iTBS.
1 week after iTBS (post iTBS)
Adverse effects report form (Seizure)
Time Frame: 1 week after iTBS (post iTBS)
Recording adverse effects in participants after iTBS.
1 week after iTBS (post iTBS)
Adverse effects report form (Other)
Time Frame: 1 week after iTBS (post iTBS)
Recording adverse effects in participants after iTBS.
1 week after iTBS (post iTBS)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI T1
Time Frame: Within one month
Brain structural volumes (cm²)
Within one month
functional MRI (resting-state/biological motion task) - BOLD signal
Time Frame: Within one month
Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.
Within one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2022

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

October 11, 2022

First Submitted That Met QC Criteria

October 12, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202200409A0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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