Explore the Therapeutic Effect of Theta Burst Stimulation on Emotion Regulation in Autism With Minimally Verbal Ability or Intellectual Disability

NCT ID: NCT06974838

Last Updated: 2025-05-16

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-26

Study Completion Date

2029-12-31

Brief Summary

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The investigator would like to investigate the impact of theta-burst stimulation over left DLPFC in autism with minimally verbal ability or intellectual disability

Detailed Description

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Conditions

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Autism Spectrum Disorder Minimally Verbal Ability Intellectual Disability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Active

Participants received the real intervention of TBS (iTBS 1200) over the left dorsolateral prefrontal cortex for 4 weeks (5 days/week).

\*iTBS = intermittent theta burst stimulation

Group Type ACTIVE_COMPARATOR

intermittent theta burst stimulation

Intervention Type DEVICE

stimulatory protocol

Sham

Participants received the sham intervention of TBS (with 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

* Diagnosis of autism spectrum disorder, confirmed by DSM-5.
* Individuals with minimal verbal ability or intellectual disability (FSIQ \< 70).

Exclusion Criteria

* Current or past severe neurological disorders, such as epilepsy, or significant visual or hearing impairments.
* Current or past severe systemic diseases, such as cardiovascular disease, diabetes, or multiple sclerosis.
* History of severe brain injury.
* Presence of implanted metal devices, such as a pacemaker or medication pump.
* Current or past severe psychiatric disorders, such as schizophrenia, bipolar disorder, or major depressive disorder.
* Pregnancy.
* Significant brain abnormalities, such as intracranial space-occupying lesions.
* Family history of epilepsy.
* History of febrile seizures.
* Concurrent use of medications that increase the risk of seizures.
* Sleep disorders during rTMS procedures.
* Skin lesions or trauma at the stimulation site.
* Deemed ineligible by the principal investigator (PI).
* Participation in another clinical trial within the past month.
* Suicidal ideation or suicide attempts within the past year.
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

Countries

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Taiwan

Central Contacts

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Hsing-Chang Ni, Ph.D

Role: CONTACT

88633281200 ext. 2479

Other Identifiers

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202302085A0

Identifier Type: -

Identifier Source: org_study_id

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