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

Conditions

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

  • United States
    • New York
      • 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:

  1. English Speaking
  2. Capacity to give consent and sign HIPAA Authorization
  3. 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
  4. ASD diagnosis according to the DSM-IV TR Symptom and Criterion checklist for ASD
  5. 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:

  1. Women of child-bearing potential not using birth control, pregnant or breast feeding
  2. H/o Bipolar Disorder (lifetime), any Psychotic Disorder (lifetime) history of Major Depressive Disorder or of substance abuse or dependence within the past year
  3. Significant sub-average intellectual function (IQ<70)
  4. Intracranial implants
  5. 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.
  6. Current significant laboratory abnormality
  7. 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
Procedure: transcranial magnetic stimulation
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.

Sponsor

New York State Psychiatric Institute

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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