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

Primary Purpose

Autism Spectrum Disorder

Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
intermittent theta burst stimulation
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active

Arm Description

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.

Outcomes

Primary Outcome Measures

Adverse effects report form (Headache)
Recording adverse effects in participants after iTBS.
Adverse effects report form (Dizziness)
Recording adverse effects in participants after iTBS.
Adverse effects report form (Tinnitus)
Recording adverse effects in participants after iTBS.
Adverse effects report form (Seizure)
Recording adverse effects in participants after iTBS.
Adverse effects report form (Other)
Recording adverse effects in participants after iTBS.

Secondary Outcome Measures

MRI T1
Brain structural volumes (cm²)
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.

Full Information

First Posted
October 11, 2022
Last Updated
August 29, 2023
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05578261
Brief Title
Explore the Impacts of One Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder
Official Title
Explore the Impacts of One Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 28, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
intermittent theta burst stimulation
Intervention Description
stimulatory protocol
Primary Outcome Measure Information:
Title
Adverse effects report form (Headache)
Description
Recording adverse effects in participants after iTBS.
Time Frame
1 week after iTBS (post iTBS)
Title
Adverse effects report form (Dizziness)
Description
Recording adverse effects in participants after iTBS.
Time Frame
1 week after iTBS (post iTBS)
Title
Adverse effects report form (Tinnitus)
Description
Recording adverse effects in participants after iTBS.
Time Frame
1 week after iTBS (post iTBS)
Title
Adverse effects report form (Seizure)
Description
Recording adverse effects in participants after iTBS.
Time Frame
1 week after iTBS (post iTBS)
Title
Adverse effects report form (Other)
Description
Recording adverse effects in participants after iTBS.
Time Frame
1 week after iTBS (post iTBS)
Secondary Outcome Measure Information:
Title
MRI T1
Description
Brain structural volumes (cm²)
Time Frame
Within one month
Title
functional MRI (resting-state/biological motion task) - BOLD signal
Description
Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.
Time Frame
Within one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
Country
Taiwan

12. IPD Sharing Statement

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

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