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

NCT ID: NCT05578261

Last Updated: 2023-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-28

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

intermittent theta burst stimulation

Intervention Type DEVICE

stimulatory protocol

Interventions

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intermittent theta burst stimulation

stimulatory protocol

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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202200409A0

Identifier Type: -

Identifier Source: org_study_id

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