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rTMS for Adults With Autistic Spectrum Disorder

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01918787
First received: August 2, 2013
Last updated: August 7, 2013
Last verified: April 2012
  Purpose
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 Intervention Phase
Autism
Device: repetitive TMS
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Examine the Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) Over the Symptoms of Autism Spectrum Disorder

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • continuous performance test [ Time Frame: continuous performance test will be arranged before and after rTMS within one hour ] [ Designated as safety issue: No ]
    continuous performance test will be arranged before and after rTMS within one hour


Secondary Outcome Measures:
  • Yale-Brown Obsessive Compulsive Scale [ Time Frame: Yale-Brown Obsessive Compulsive Scale will be evaluated before and after rTMS within one week ] [ Designated as safety issue: No ]
    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:
  • Autism Spectrum Quotient [ Time Frame: Autism Spectrum Quotient will be evaluated before and after rTMS within one week ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: April 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01918787

Locations
Taiwan
Chang Gung Memorial Hospital
Taoyuan, Taiwan
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 
Study First Received: August 2, 2013
Last Updated: August 7, 2013
Health Authority: Taiwan: Department of Health

ClinicalTrials.gov processed this record on December 09, 2016