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

Autism Clinical Trial

Official title:

Repetetive Transcranial Magnetic Stimulation for Evaluation and Treatment of Repetetive Behavior in Subjects With Autism Spectrum Disorders.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01983189
• Other study ID #: 5594
• Status: Terminated
• Phase: Phase 2
• First received: March 14, 2012
• Last updated: November 6, 2013
• Start date: November 2008
• Est. completion date: November 2010

Study information

• Verified date: November 2013
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asperger Disorder
• Asperger Syndrome
• Autism
• Autistic Disorder
• Disease
• Other Developmental Pervasive Disorder.

Intervention

Procedure:
• transcranial magnetic stimulation
1 hz transcranial magnetic stimulation

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute, 1051 Riverside Drive	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical improvement based on repetitive behavior scale.		baseline-week3	No
Secondary	clinical improvement based on the social responsiveness scale.		before-week3	No