- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01918787
rTMS for Adults With Autistic Spectrum Disorder
August 7, 2013 updated by: Chang Gung Memorial Hospital
Examine the Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) Over the Symptoms of Autism Spectrum Disorder
rTMS over dorsolateral prefrontal cortex is effective in reducing repetitive behaviors in adults with autistic spectrum disorder rTMS over posterior superior temporal sulcus is effective in improving social ability in adults with autistic spectrum disorder
Study Overview
Detailed Description
First, we will apply one session intermittent theta burst stimulation over dorsolateral prefrontal cortex, posterior superior temporal sulcus and inion as control with one week interval in adults with autism spectrum disorder.
Second, we will apply 5 sessions intermittent theta burst stimulation within one week over dorsolateral prefrontal cortex or posterior temporal sulcus depending on the results of our first phases.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Taoyuan, Taiwan
- Recruiting
- Chang Gung Memorial Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adults with autistic spectrum disorder
Exclusion Criteria:
- schizophrenia
- bipolar affective disorder
- major depressive disorder
- any systemic disease especially epilepsy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: repetitive TMS
repetitive TMS over dorsolateral prefrontal cortex, posterior superior temporal sulcus and inion as control
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rTMS (intermittent theta burst stimulation 1200)over posterior superior temporal sulcus,dorsolateral prefrontal cortex and inion as Sham control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
continuous performance test
Time Frame: continuous performance test will be arranged before and after rTMS within one hour
|
continuous performance test will be arranged before and after rTMS within one hour
|
continuous performance test will be arranged before and after rTMS within one hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Yale-Brown Obsessive Compulsive Scale
Time Frame: Yale-Brown Obsessive Compulsive Scale will be evaluated before and after rTMS within one week
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Yale-Brown Obsessive Compulsive Scale will be evaluated before and after rTMS.
The time point of evaluation is before rTMS, one hour after rTMS, 3 days after rTMS and one week after rTMS.
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Yale-Brown Obsessive Compulsive Scale will be evaluated before and after rTMS within one week
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Autism Spectrum Quotient
Time Frame: Autism Spectrum Quotient will be evaluated before and after rTMS within one week
|
Autism Spectrum Quotient will be evaluated before and after rTMS.
The time point of evaluation is before rTMS, one hour after rTMS, 3 days after rTMS and one week after rTMS.
|
Autism Spectrum Quotient will be evaluated before and after rTMS within one week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hsing-Chang Ni, MD, Chang Gung Memorial Hospital at Linkou, Taiwan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Anticipated)
April 1, 2015
Study Completion (Anticipated)
April 1, 2015
Study Registration Dates
First Submitted
August 2, 2013
First Submitted That Met QC Criteria
August 7, 2013
First Posted (Estimate)
August 8, 2013
Study Record Updates
Last Update Posted (Estimate)
August 8, 2013
Last Update Submitted That Met QC Criteria
August 7, 2013
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100-2985C
- NSC 100-2314-B-182A-075 (Other Identifier: National Science Council)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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