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

NCT ID: NCT04993144

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2022-09-30

Brief Summary

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The investigator would like to investigate the impact of theta burst stimulation over left dorsolateral prefrontal cortex 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 (cTBS 600) over the left dorsolateral prefrontal cortex for 8 weeks (2 days/week).

\*cTBS = continuous theta burst stimulation

Group Type ACTIVE_COMPARATOR

continuous 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 left dorsolateral prefrontal cortex for 8 weeks (2 days/week).

Group Type SHAM_COMPARATOR

continuous theta burst stimulation

Intervention Type DEVICE

stimulatory protocol

Normal control

No intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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continuous 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, 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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201802246A0

Identifier Type: -

Identifier Source: org_study_id

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