Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Transcranial Magnetic Stimulation for the Treatment of Parkinson's Disease

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: NCT00001665
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Tracking Information
First Submitted Date November 3, 1999
First Posted Date December 10, 2002
Last Update Posted Date March 4, 2008
Study Start Date January 1997
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00001665 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Transcranial Magnetic Stimulation for the Treatment of Parkinson's Disease
Official Title Can Subthreshold Transcranial Magnetic Stimulation (rTMS) to Motor Cortex and/or to Supplementary Motor Area (SMA) Improve Performance of Complex Motor Sequences in Parkinson's Disease?
Brief Summary

The problems in motor activity associated with Parkinson's disease are still poorly understood. Patients with Parkinson's disease often suffer from extremely slow movements (bradykinesia) which result in the inability to perform complex physical acts.

Imaging studies of the brain have provided researchers with information about the specific areas in the brain associated with these motor difficulties. One particular area involved is the surface of the brain called the cerebral cortex.

Transcranial Magnetic Stimulation (TMS) is a non-invasive technique that can be used to stimulate brain activity and gather information about brain function. It is very useful when studying the areas of the brain related to motor activity (motor cortex, corticospinal tract, and corpus callosum). Repetitive transcranial magnetic stimulation (rTMS) involves the placement of a cooled electromagnet with a figure-eight coil on the patient's scalp and rapidly turning on and off the magnetic flux. This permits non-invasive, relatively localized stimulation of the surface of the brain (cerebral cortex). The effect of magnetic stimulation varies, depending upon the location, intensity and frequency of the magnetic pulses.

Researchers plan to study the therapeutic effects of repetitive transcranial magnetic stimulation (rTMS) on complex motor behavior of patients with Parkinson's disease. In order to measure its effectiveness, patients will be asked to perform complex tasks, such as playing the piano while receiving transcranial magnetic stimulation.

Detailed Description

The physiology of the motor disturbance in Parkinson's disease is not completely understood. One of the major and perhaps most disabling manifestations of PD is bradykinesia. It is particularly difficult for these patients to perform simultaneous, sequential and complex motor acts. Imaging studies have recently provided important information in reference to the brain regions associated with performance of these motor sequences in normal volunteers and in PD patients. These studies helped us to identify the brain regions active in association with task performance. It has been suggested that cortical regions, and particularly the SMA are less active in patients with PD than in controls in association with motor performance.

We plan to study the effects of subthreshold rTMS delivered to SMA and primary motor cortex in patients with PD "on" and "off" medication. From this study, we expect to learn if stimulation of the scalp overlying primary motor cortex and SMA can ameliorate performance of simple and complex motor sequences in PD.

Subthreshold rTMS has been proposed as a therapeutic tool in psychiatric disorders. In the motor domain, subthreshold rTMS delivered to primary motor cortex improves reaction times and motor performance in patients with Parkinson's disease. The mechanisms underlying this beneficial effect are not known. However, they may be related with subthreshold rTMS replacing the missing excitatory drive on the motor cortex.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Movement Disorders
  • Parkinson Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: June¬†23,¬†2005)
12
Original Enrollment Same as current
Study Completion Date September 2000
Primary Completion Date Not Provided
Eligibility Criteria

Patients with PD.

No epilepsy.

No seizures.

No metal in the head.

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00001665
Other Study ID Numbers 970073
97-N-0073
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators Not Provided
Investigators Not Provided
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date December 1999