Back to resultsrTMS for Adults With Autistic Spectrum Disorder
Primary Purpose
Autism
Status
Unknown status
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
repetitive TMS
Sponsored by
About this trial
This is an interventional treatment trial for Autism
Eligibility Criteria
Inclusion Criteria:
- adults with autistic spectrum disorder
Exclusion Criteria:
- schizophrenia
- bipolar affective disorder
- major depressive disorder
- any systemic disease especially epilepsy
Sites / Locations
- Chang Gung Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
repetitive TMS
Arm Description
repetitive TMS over dorsolateral prefrontal cortex, posterior superior temporal sulcus and inion as control
Outcomes
Primary Outcome Measures
continuous performance test
continuous performance test will be arranged before and after rTMS within one hour
Secondary Outcome Measures
Yale-Brown Obsessive Compulsive Scale
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.
Full Information
NCT ID
NCT01918787
First Posted
August 2, 2013
Last Updated
August 7, 2013
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01918787
Brief Title
rTMS for Adults With Autistic Spectrum Disorder
Official Title
Examine the Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) Over the Symptoms of Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
April 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
repetitive TMS
Arm Type
Experimental
Arm Description
repetitive TMS over dorsolateral prefrontal cortex, posterior superior temporal sulcus and inion as control
Intervention Type
Device
Intervention Name(s)
repetitive TMS
Intervention Description
rTMS (intermittent theta burst stimulation 1200)over posterior superior temporal sulcus,dorsolateral prefrontal cortex and inion as Sham control
Primary Outcome Measure Information:
Title
continuous performance test
Description
continuous performance test will be arranged before and after rTMS within one hour
Time Frame
continuous performance test will be arranged before and after rTMS within one hour
Secondary Outcome Measure Information:
Title
Yale-Brown Obsessive Compulsive Scale
Description
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.
Time Frame
Yale-Brown Obsessive Compulsive Scale will be evaluated before and after rTMS within one week
Other Pre-specified Outcome Measures:
Title
Autism Spectrum Quotient
Description
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.
Time Frame
Autism Spectrum Quotient will be evaluated before and after rTMS within one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults with autistic spectrum disorder
Exclusion Criteria:
schizophrenia
bipolar affective disorder
major depressive disorder
any systemic disease especially epilepsy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsing Chang Ni, MD
Phone
886-3-3281200
Ext
2479
Email
alanni0918@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsing-Chang Ni, MD
Organizational Affiliation
Chang Gung Memorial Hospital at Linkou, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsing Chang Ni
Phone
886-3-3281200
Ext
2479
Email
alanni0918@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Hsing Chang Ni, MD
12. IPD Sharing Statement
Learn more about this trial
rTMS for Adults With Autistic Spectrum Disorder
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