ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 72 for:    "Asperger syndrome"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01983189
Recruitment Status : Terminated (Principal investigator (Dr. Sporn) left the sponsoring institution.)
First Posted : November 13, 2013
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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 : November 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. clinical improvement based on repetitive behavior scale. [ Time Frame: baseline-week3 ]

Secondary Outcome Measures :
  1. clinical improvement based on the social responsiveness scale. [ Time Frame: before-week3 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01983189


Locations
United States, New York
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

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01983189     History of Changes
Other Study ID Numbers: 5594
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: January 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
Pathologic Processes
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders