Repetetive Transcranial Magnetic Stimulation for Evaluation and Treatment of Repetetive Behavior in Subjects With Autism Spectrum Disorders.
Transcranial Magnetic Stimulation for Evaluation and Treatment of Repetetive Behaviors in Autism
Sponsors
Source
New York State Psychiatric Institute
Oversight Info
Has Dmc
Yes
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.
Overall Status
Terminated
Start Date
2008-11-01
Completion Date
2010-11-01
Primary Completion Date
2010-11-01
Phase
Phase 2
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
clinical improvement based on repetitive behavior scale. |
baseline-week3 |
Secondary Outcome
Measure |
Time Frame |
|
clinical improvement based on the social responsiveness scale. |
before-week3 |
Enrollment
10
Conditions
Intervention
Intervention Type
Procedure
Intervention Name
Description
1 hz transcranial magnetic stimulation
Arm Group Label
Low frequency rTMS
Eligibility
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 -
Gender
All
Minimum Age
18 Years
Maximum Age
55 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Alexandra Sporn, MD |
Principal Investigator |
New York State Psychiatric Institute |
Location
Facility |
|
New York State Psychiatric Institute, 1051 Riverside Drive New York New York 10032 United States |
Location Countries
Country
United States
Verification Date
2017-01-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
1
Arm Group
Arm Group Label
Low frequency rTMS
Arm Group Type
Experimental
Description
low frequency, repetitive transcranial magnetic stimulation (rTMS) for 20 minutes daily, 5 times a week for 3 weeks
Firstreceived Results Date
N/A
Why Stopped
Principal investigator (Dr. Sporn) left the sponsoring institution.
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)
Study First Submitted
March 14, 2012
Study First Submitted Qc
November 6, 2013
Study First Posted
November 13, 2013
Last Update Submitted
January 12, 2017
Last Update Submitted Qc
January 12, 2017
Last Update Posted
March 24, 2017
ClinicalTrials.gov processed this data on May 29, 2020
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.