- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01983189
Transcranial Magnetic Stimulation for Evaluation and Treatment of Repetetive Behaviors in Autism
January 12, 2017 updated by: New York State Psychiatric Institute
Repetetive Transcranial Magnetic Stimulation for Evaluation and Treatment of Repetetive Behavior in Subjects With Autism Spectrum Disorders.
This study is a trial of low frequency Repetitive Transcranial magnetic stimulation( rTMS) for subjects with autism spectrum disorders, specially targeting repetitive behaviors.
Study Overview
Status
Terminated
Intervention / Treatment
Detailed Description
This project is a 3-week double blind cross-over trial for adolescents and adults who meet criteria for autism and have clinically prominent repetitive behaviors.
The investigator will apply low frequency rTMS for 20 minutes 5 times a week for 3 weeks targeting the area of brain which was involved in repetitive behaviors.
The investigator will obtain clinical measures of repetitive behaviors as well as social functioning pre and post treatment.
As a control and a cross-over condition , we will stimulate other area of brain which has nothing to do with repetitive behaviors but may improve social functioning in autism spectrum disorders.
In addition to r TMS we will perform a pre and post treatment perfusion functional MRI and obtain TMS measure of excitability of brain.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 2
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
-
-
New York
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New York, New York, United States, 10032
- New York State Psychiatric Institute, 1051 Riverside Drive
-
-
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 55 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- English Speaking
- Capacity to give consent and sign HIPAA Authorization
- Patients currently taking psychotropic medications must be at the same stable dose and likely to be able to continue at the same dose throughout the study
- ASD diagnosis according to the DSM-IV TR Symptom and Criterion checklist for ASD
- Significant level of repetitive behaviors to distinguish from movement disorders to be in at least 3 out of 6 sub-scales (stereotyped behavior, self-injurious behavior, compulsive behavior, ritualistic behavior, sameness behavior, restricted behavior) -
Exclusion Criteria:
- Women of child-bearing potential not using birth control, pregnant or breast feeding
- H/o Bipolar Disorder (lifetime), any Psychotic Disorder (lifetime) history of Major Depressive Disorder or of substance abuse or dependence within the past year
- Significant sub-average intellectual function (IQ<70)
- Intracranial implants
- Increased risk of seizure for any reason, including prior diagnosis of epilepsy, seizure disorder, febrile seizure, increased intracranial pressure or history of significant head trauma with loss of consciousness for > 5 minutes.
- Current significant laboratory abnormality
- Neurological disorder including but not limited to space occupying brain lesion, any history of seizures, history of cerebrovascular accident, fainting, cerebral aneurysm, dementia, Huntington chorea, Multiple Sclerosis -
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Low frequency rTMS
low frequency, repetitive transcranial magnetic stimulation (rTMS) for 20 minutes daily, 5 times a week for 3 weeks
|
1 hz transcranial magnetic stimulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
clinical improvement based on repetitive behavior scale.
Time Frame: baseline-week3
|
baseline-week3
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
clinical improvement based on the social responsiveness scale.
Time Frame: before-week3
|
before-week3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Alexandra Sporn, MD, New York State Psychiatric Institute
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
November 1, 2008
Primary Completion (ACTUAL)
November 1, 2010
Study Completion (ACTUAL)
November 1, 2010
Study Registration Dates
First Submitted
March 14, 2012
First Submitted That Met QC Criteria
November 6, 2013
First Posted (ESTIMATE)
November 13, 2013
Study Record Updates
Last Update Posted (ACTUAL)
March 24, 2017
Last Update Submitted That Met QC Criteria
January 12, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5594
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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