The Therapeutic Effects of Intermittent Theta Burst Stimulation in Autism Spectrum Disorder

NCT ID: NCT04987749

Last Updated: 2022-07-08

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-05

Study Completion Date

2023-11-30

Brief Summary

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The investigator would like to investigate the impact of theta burst stimulation over right inferior frontal gyrus 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 Caregivers

Study Groups

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Active

Participants received the real intervention of TBS (iTBS 600) over the right inferior frontal gyrus for 8 weeks (2 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 (coil tilted one-wing 90° off the head) over the right inferior frontal gyrus for 8 weeks (2 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

* current and past systemic disease
* current and past major psychiatric disorders including schizophrenia, bipolar affective disorder and major depressive disorder
* current and past brain injuries
* intelligence \< 70
* seizure history
* pregnant
Minimum Eligible Age

8 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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

Role: CONTACT

88633281200 ext. 3815

Facility Contacts

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Hsing-Chang Ni, Dr

Role: primary

88633281200 ext. 3815

References

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Ni HC, Chen YL, Hsieh MY, Wu CT, Chen RS, Juan CH, Li CT, Gau SS, Lin HY. Improving social cognition following theta burst stimulation over the right inferior frontal gyrus in autism spectrum: an 8-week double-blind sham-controlled trial. Psychol Med. 2024 Sep 6:1-12. doi: 10.1017/S0033291724001387. Online ahead of print.

Reference Type DERIVED
PMID: 39238103 (View on PubMed)

Other Identifiers

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201900713A0

Identifier Type: -

Identifier Source: org_study_id

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