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Transcranial Magnetic Stimulation for Evaluation and Treatment of Repetetive Behaviors in Autism

Primary Purpose

Autism, Asperger Disorder, Other Developmental Pervasive Disorder

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
transcranial magnetic stimulation
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring TMS, transcranial magnetic stimulation, rTMS, recurrent transcranial magnetic stimulation, fMRI, functional magnetic resonance imaging.

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • New York State Psychiatric Institute, 1051 Riverside Drive

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Low frequency rTMS

Arm Description

low frequency, repetitive transcranial magnetic stimulation (rTMS) for 20 minutes daily, 5 times a week for 3 weeks

Outcomes

Primary Outcome Measures

clinical improvement based on repetitive behavior scale.

Secondary Outcome Measures

clinical improvement based on the social responsiveness scale.

Full Information

First Posted
March 14, 2012
Last Updated
January 12, 2017
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01983189
Brief Title
Transcranial Magnetic Stimulation for Evaluation and Treatment of Repetetive Behaviors in Autism
Official Title
Repetetive Transcranial Magnetic Stimulation for Evaluation and Treatment of Repetetive Behavior in Subjects With Autism Spectrum Disorders.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Principal investigator (Dr. Sporn) left the sponsoring institution.
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a trial of low frequency Repetitive Transcranial magnetic stimulation( rTMS) for subjects with autism spectrum disorders, specially targeting repetitive behaviors.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Asperger Disorder, Other Developmental Pervasive Disorder
Keywords
TMS, transcranial magnetic stimulation, rTMS, recurrent transcranial magnetic stimulation, fMRI, functional magnetic resonance imaging.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low frequency rTMS
Arm Type
Experimental
Arm Description
low frequency, repetitive transcranial magnetic stimulation (rTMS) for 20 minutes daily, 5 times a week for 3 weeks
Intervention Type
Procedure
Intervention Name(s)
transcranial magnetic stimulation
Intervention Description
1 hz transcranial magnetic stimulation
Primary Outcome Measure Information:
Title
clinical improvement based on repetitive behavior scale.
Time Frame
baseline-week3
Secondary Outcome Measure Information:
Title
clinical improvement based on the social responsiveness scale.
Time Frame
before-week3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Sporn, MD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute, 1051 Riverside Drive
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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Transcranial Magnetic Stimulation for Evaluation and Treatment of Repetetive Behaviors in Autism

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