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Official Study Title: 50 Hz Repetitive Transcranial Magnetic Stimulation  Transcranial Magnetic Stimulation (TMS)Brief electrical currents are passed through an insulated wire coil placed on the subject's scalp and the coil, creating magnetic pulses that pass into the brain. (rTMS) for the Treatment of Parkinson's Disease
Sponsor: National Institute of Neurological Disorders and Stroke  National Institute of Neurological Disorders and Stroke (NINDS)A branch of the National Institutes of Health whose research concentrates on the brain and conditions that result in brain function irregularities. The NINDS funds much of the research on Parkinson's disease.  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. Internet address: http://www.ninds.nih.gov (NINDS)
Clinicaltrials.gov ID: NCT00977184
Study ID: 090221, 09-N-0221

Summary

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 (PD), 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)  PlaceboAn inactive substance or procedure (often a pill, liquid, or powder) that has no biological effect. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants will be assigned to a control group and will receive a placebo instead of an active drug or treatment. rTMS. Half of the people in this study will have active rTMS; the other half will have no brain stimulation with rTMS. The objective is to see if a faster rate of transcranial magnetic stimulation is a more effective treatment for PD symptoms than the slower rates that have been studied.

This study requires 11 outpatient visits to the NIH Clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. Center over six 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).

Study Phase

Phase 1/2
What is a study phase?

Symptoms Addressed: Movement Symptoms

Walking/Gait  GaitWay of walking, which is diminished in people with Parkinson’s who tend to shuffle their feet, take too short steps, and not swing one or both arms.

Time Commitment

• Contact trial organizers

Eligibility

• Minimum Age: 40
• Maximum Age: 80
• Gender(s) Accepted: Either

Inclusion Criteria

• Diagnosis of PD
• Must be on a regimen including levodopa
• Total dose of levodopa  LevodopaA compound that is converted into dopamine (the brain chemical which is deficient in people with Parkinson's) in the brain. and dopamine  DopamineA "chemical messenger" that regulates movement by assisting in the effective communication (transmission) of electrochemical signals in the brain from one nerve cell (neuron) to another. As dopamine producing cells degenerate with advancing PD, they no longer produce enough to regulate neurons elsewhere in the brain, resulting in a loss of control of movements, leading to symptoms such as slowed movements, tremor, and rigidity. 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
• Pallidotomy, implanted electrodes and generator for deep brain stimulation
  

Enrollment

Expected Enrollment: 30 (US)
Date Enrollment Began: Sep 2009
Date Enrollment Ends: May 2011
Last Updated Date: Oct 19 2009
Trial Post Date: Oct 19 2009
Website: http://clinicaltrials.gov/ct2/show/NCT00977184

Primary Contacts and Locations

Maryland

• Patient Recruitment and Public Liaison Office
  prpl@mail.cc.nih.gov
  Phone: (800) 411-1222
  National Institutes of Health  National Institutes of Health (NIH)The National Institutes of Health, a part of the U.S. Department of Health and Human Services, is the primary Federal agency for conducting and supporting medical research. Headquartered in Bethesda Maryland, it is composed of 27 Institutes and Centers and provides leadership and financial support to researchers in every state and throughout the world. Internet address: http://www.nih.gov. Clinical Center
  9000 Rockville Pike
  Bethesda, MD 20892
  USA