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

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01983189
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Autism; Asperger Disorder; Other Developmental Pervasive Disorder	Procedure: transcranial magnetic stimulation	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Repetetive Transcranial Magnetic Stimulation for Evaluation and Treatment of Repetetive Behavior in Subjects With Autism Spectrum Disorders.
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. clinical improvement based on repetitive behavior scale. [baseline-week3]

Secondary Outcome Measures

1. clinical improvement based on the social responsiveness scale. [before-week3]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York State Psychiatric Institute, 1051 Riverside Drive	New York	New York	United States	10032

Sponsors and Collaborators

• New York State Psychiatric Institute

Investigators

• Principal Investigator: Alexandra Sporn, MD, New York State Psychiatric Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT01983189
• Other Study ID Numbers: 5594
• First Posted: Nov 13, 2013
• Last Update Posted: Mar 24, 2017
• Last Verified: Jan 1, 2017

• Keywords provided by New York State Psychiatric Institute: TMS; transcranial magnetic stimulation; rTMS; recurrent transcranial magnetic stimulation; fMRI; functional magnetic resonance imaging.
• Additional relevant MeSH terms: Disease; Autistic Disorder; Asperger Syndrome

Study Results

No Results Posted as of Mar 24, 2017