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rTMS for Adults With Autistic Spectrum Disorder

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ClinicalTrials.gov Identifier: NCT01918787
Recruitment Status : Unknown
Verified April 2012 by Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : August 8, 2013
Last Update Posted : August 8, 2013
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Autism Device: repetitive TMS Phase 1 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Examine the Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) Over the Symptoms of Autism Spectrum Disorder
Study Start Date : April 2012
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: repetitive TMS
repetitive TMS over dorsolateral prefrontal cortex, posterior superior temporal sulcus and inion as control
Device: repetitive TMS
rTMS (intermittent theta burst stimulation 1200)over posterior superior temporal sulcus,dorsolateral prefrontal cortex and inion as Sham control


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Yale-Brown Obsessive Compulsive Scale [ Time Frame: Yale-Brown Obsessive Compulsive Scale will be evaluated before and after rTMS within one week ]
    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.


Other Outcome Measures:
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults with autistic spectrum disorder

Exclusion Criteria:

  • schizophrenia
  • bipolar affective disorder
  • major depressive disorder
  • any systemic disease especially epilepsy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01918787


Contacts
Contact: Hsing Chang Ni, MD 886-3-3281200 ext 2479 alanni0918@yahoo.com.tw

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan
Contact: Hsing Chang Ni    886-3-3281200 ext 2479    alanni0918@yahoo.com.tw   
Principal Investigator: Hsing Chang Ni, MD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Hsing-Chang Ni, MD Chang Gung Memorial Hospital at Linkou, Taiwan
More Information

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01918787     History of Changes
Other Study ID Numbers: 100-2985C
NSC 100-2314-B-182A-075 ( Other Identifier: National Science Council )
First Posted: August 8, 2013    Key Record Dates
Last Update Posted: August 8, 2013
Last Verified: April 2012