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

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05578261
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
9
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: intermittent theta burst stimulation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Explore the Impacts of One Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Adverse effects report form (Headache) [1 week after iTBS (post iTBS)]

    Recording adverse effects in participants after iTBS.

  2. Adverse effects report form (Dizziness) [1 week after iTBS (post iTBS)]

    Recording adverse effects in participants after iTBS.

  3. Adverse effects report form (Tinnitus) [1 week after iTBS (post iTBS)]

    Recording adverse effects in participants after iTBS.

  4. Adverse effects report form (Seizure) [1 week after iTBS (post iTBS)]

    Recording adverse effects in participants after iTBS.

  5. Adverse effects report form (Other) [1 week after iTBS (post iTBS)]

    Recording adverse effects in participants after iTBS.

Secondary Outcome Measures

  1. MRI T1 [Within one month]

    Brain structural volumes (cm²)

  2. functional MRI (resting-state/biological motion task) - BOLD signal [Within one month]

    Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chang Gung Memorial Hospital Taoyuan Taiwan

Sponsors and Collaborators

  • Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT05578261
Other Study ID Numbers:
  • 202200409A0
First Posted:
Oct 13, 2022
Last Update Posted:
Oct 13, 2022
Last Verified:
Jul 1, 2022
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
Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive

Study Results

No Results Posted as of Oct 13, 2022