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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01918787
Other study ID # 100-2985C
Secondary ID NSC 100-2314-B-1
Status Recruiting
Phase Phase 1/Phase 2
First received August 2, 2013
Last updated August 7, 2013
Start date April 2012
Est. completion date April 2015

Study information

Verified date April 2012
Source Chang Gung Memorial Hospital
Contact Hsing Chang Ni, MD
Phone 886-3-3281200
Email alanni0918@yahoo.com.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- adults with autistic spectrum disorder

Exclusion Criteria:

- schizophrenia

- bipolar affective disorder

- major depressive disorder

- any systemic disease especially epilepsy

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Taiwan Chang Gung Memorial Hospital Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Other Autism Spectrum Quotient 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 No
Primary continuous performance test 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 No
Secondary 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. Yale-Brown Obsessive Compulsive Scale will be evaluated before and after rTMS within one week No
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