The Therapeutic Effect of TBS Stimulation on Emotion Regulation in Autism Spectrum Disorder

NCT ID: NCT04987541

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

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-06

Study Completion Date

2025-12-31

Brief Summary

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The investigator would like to investigate the impact of intermittent theta burst stimulation over left dorsolateral prefrontal cortex on emotion regulation in 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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active

Participants received the real intervention of TBS (iTBS 600) over the left dorsolateral prefrontal cortex for 4 weeks (5 days/week).

\*iTBS = intermittent theta burst stimulation

Group Type EXPERIMENTAL

intermittent theta burst stimulation

Intervention Type DEVICE

stimulatory protocol

Sham

Participants received the sham intervention of TBS (sham-coil) over the left dorsolateral prefrontal cortex for 4 weeks (5 days/week).

Group Type SHAM_COMPARATOR

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

* autism spectrum disorder, confirmed by ADOS

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
* Individuals with a family history of epilepsy
* Previous febrile seizures
* Current taking antiepileptic drugs
* Concurrent use of medications which increased the risk of seizure attack
* Individuals suffering from sleep deprivation during rTMS procedures
* Skin trauma on application site
* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to participate in the study
* Participate another clinical trial within one month
Minimum Eligible Age

8 Years

Maximum Eligible Age

30 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 RECRUITING

Countries

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Taiwan

Central Contacts

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Hsing-Chang Ni, Dr.

Role: CONTACT

88633281200 ext. 3815

Facility Contacts

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Hsing-Chang Ni, Dr

Role: primary

88633281200 ext. 3815

Other Identifiers

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202002498A0

Identifier Type: -

Identifier Source: org_study_id

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