50 Hz Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Parkinson's Disease - Full Text View

Sponsor:	National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00977184

Purpose

Background:

In transcranial magnetic stimulation (TMS), a device creates a short-lasting magnetic field which induces an electric current in the brain leading to a change in the activity of brain cells. There are different effects on the brain with different rates of stimulation. In a previous study in people with Parkinson's disease, repetitive TMS (rTMS) given at a particular rate temporarily improved their ability to walk. A faster rate of rTMS may be more effective in treating symptoms than the rate originally used.
This study will compare active rTMS to inactive (sham or Placebo) rTMS. Half of the people in this study will have active rTMS; the other half will have no brain stimulation with rTMS.

Objectives:

- To see if a faster rate of transcranial magnetic stimulation is a more effective treatment for the symptoms of Parkinson's disease than the slower rates that have been studied.

Eligibility:

Individuals between 40 and 80 years of age who have been diagnosed with mild or moderate Parkinson's disease.
Participants must currently be taking Sinemet or dopamine agonists drugs (e.g., bromocriptine, cabergoline, pergolide, pramipexole, ropinirole, apomorophine, and rotigotine), and are willing to continue their same treatments for the duration of the study.

Design:

This study requires 11 outpatient visits to the NIH Clinical Center over 6 weeks. Participants can also be admitted and stay as an inpatient in the NIH Clinical Center for the entire study period (for the 10 visits during the first weeks and the follow-up visit a month later).
Initial visit will consist of a physical examination; a test of participants' time to walk 10 meters; and questions about memory, mood, and quality of life. Participants should not take Parkinson's disease medications for 12 hours before this visit; once the examinations and tests are complete, participants will be able to take the medications. Researchers will repeat the tests 1 hour after participants take the medication.
TMS sessions: 8 TMS sessions (4 sessions per week) over 2 weeks. Each stimulation session will last half an hour. Half of the participants will receive active TMS; the other half will receive sham TMS.
The first 10 participants will have additional tests to study the safety of rapid TMS in patients with Parkinson's disease.
A day after completing the last TMS session, participants will repeat the same tests as the first visit before and after taking their medication as in the first assessment and respond to questions about mood, memory, and quality of life.
One month after completing the last TMS session, participants will repeat the same tests as the first visit before and after taking their medication.

Condition	Intervention	Phase
Parkinson Disease	Procedure: 50 HZ Repetitive TMS	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	50 Hz Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Parkinson's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:

Gait will be assessed by measuring the time it takes to walk 10 meters.

Secondary Outcome Measures:

Bradykinesia will be assessed by measuring the time it takes to do ten combined hand and arm movements. Total and motor UPDRS scores.

Estimated Enrollment:	30
Study Start Date:	September 2009
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Intervention Details:

N/A

Detailed Description:

Objective:

To demonstrate cumulative and long-lasting improvement of parkinsonian symptoms by 50 Hz rTMS (repetitive transcranial magnetic stimulation) and its safety in Parkinson's Disease (PD) patients.

Study population:

Up to 30 PD patients in Hoehn and Yahr disease stage 2-4 while off medication will be enrolled. Patients must be receiving more than 300 mg of levodopa (including dopamine agonists) and have gait problems.

Design:

This is a randomized, double-blind, placebo (sham)-controlled study of 30 patients with PD in 2 groups (real versus sham stimulation). The study involves performance (8 interventions) of 50 Hz rTMS with large circular coil over the motor cortex on both sides of the brain. Assessment of PD symptoms with standard tests of motor function will be performed over a one-month period.

Outcome measure:

The primary endpoint is change in gait speed as assessed by the time it takes to walk 10 meters.

Secondary endpoints include changes in bradykinesia as assessed by measuring the time it takes to do ten combined hand and arm movements, and changes in total and motor UPDRS (Unified Parkinson's Disease Rating Scale) score.

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:

Men and women aged 40 to 80 years with DOPA-responsive PD

Hoehn and Yahr grade of 2 to 4 while off

Must be on a regimen including levodopa

Total dose of levodopa and dopamine agonists (using dopamine equivalents) has to be equal to or more than 300 milligrams per day

problems with walking and gait time for a 10-meter distance greater than six seconds or more

EXCLUSION CRITERIA:

Any active psychiatric disease

History of seizures and epilepsy

Concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs other than anti-parkinsonian agents that could lower the seizure threshold except for SSRI

Pallidotomy, implanted electrodes and generator for deep brain stimulation

Pregnancy

Surgically or traumatically implanted foreign bodies such as a pacemaker, implanted medical pump, implanted hearing aids, metal plate in the skull, or metal implant in the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during TEP.

Study would cause undue risk or stress for reasons such as tendency to fall, excessive fatigue, general frailty, or excessive apprehensiveness.

Dementia as assessed by the Folstein's Mini-Mental Test Examination (MMSE less than or equal to 24/30) or mentally impaired patients having no capacity to provide their own consent (the physician establishing the diagnosis and applying UPDRS will evaluate patient's mental capacity using conventional clinical interview)

Unable to walk a 10-meter distance.

More than occasional falls, i.e. daily falls (corresponding to a score greater than or equal to 3 and more in UPDRS item 13), history of fall(s) with significant injuries, absence of postural response in the on and/or spontaneous loss of balance in the off condition (corresponding to a score of greater than or equal to 2 and greater than or equal to 3 in on/off condition, respectively, in UPDRS item 30)

Pregnancy is unusual in patients with PD, grade 2-4. Urine sample for the pregnancy test will be obtained in patients of childbearing potential prior to starting the 50 Hz rTMS and also at the initial interview after signing the consent form. Women of childbearing potential will be asked to take appropriate measures to prevent a pregnancy during the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00977184

Contacts

Contact: Patient Recruitment and Public Liaison Office	(800) 411-1222	prpl@mail.cc.nih.gov
Contact: TTY	1-866-411-1010

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

Aarsland D, Larsen JP, Waage O, Langeveld JH. Maintenance electroconvulsive therapy for Parkinson's disease. Convuls Ther. 1997 Dec;13(4):274-7.

Baudewig J, Siebner HR, Bestmann S, Tergau F, Tings T, Paulus W, Frahm J. Functional MRI of cortical activations induced by transcranial magnetic stimulation (TMS). Neuroreport. 2001 Nov 16;12(16):3543-8.

Belmaker RH, Grisaru N. Magnetic stimulation of the brain in animal depression models responsive to ECS. J ECT. 1998 Sep;14(3):194-205. Review.

Study ID Numbers:	090221, 09-N-0221
Study First Received:	September 12, 2009
Last Updated:	November 25, 2009
ClinicalTrials.gov Identifier:	NCT00977184 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Parkinson's Disease
Transcranial Magnetic Stimulation (TMS)
Treatment Study
PD
Parkinson Disease

Additional relevant MeSH terms:

Movement Disorders
Parkinson Disease
Nervous System Diseases
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

ClinicalTrials.gov processed this record on February 08, 2010