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Official Study Title: Evaluation of the Plasticity of the Primary Motor Cortex and Motor Learning in 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: NCT00396942
Study ID: 070020; 07-N-0020

Summary

People with Parkinson's disease (PD) sometimes have trouble learning new skills, but it is not known why. This study will compare brain changes in people with PD with those of healthy participants while they learn motor skills. This study will use 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), nerve conduction studies (electrical nerve stimulation), and electroencephaolography (EEG) to look for differences in the way the brain changes with learning in people with PD. EEG measures the electrical activity of the brain (brain waves). rTMS involves repeated magnetic pulses delivered in short bursts of impulses.

Study Phase

Not Specified
What is a study phase?

Symptoms Addressed: Study does not address symptoms

Study does not address symptoms

Time Commitment

• Contact trial organizers
• 5 visits to NIH

Eligibility

• Minimum Age: 21
• Maximum Age: 80
• Gender(s) Accepted: Either

Inclusion Criteria

• Right-handed healthy volunteers.
• Idiopathic  IdiopathicOf, relating to, or designating a disease having no known cause. PD must be confirmed by either the PI or an HMCS physician.
• Any other neurologic condition that might affect cortical plasticity (the ability of the outside area of the brain to compensate for injury and disease) must be ruled out.
• Participants must fulfill categories 1 to 3 of the Modified Hoehn and Yahr Scale in the 'off-medication' state.

Exclusion Criteria

• Persons with dementia  DementiaA decline in higher-level brain functions, such as memory, reasoning and personality. [mini mental state examination (MMSE) less than 25, frontal assessment battery (FAB) less than 13].
• Persons with other parkinsonian syndromes  Parkinsonian SyndromesA group of diseases characterized by symptoms (e.g. tremor, rigidity or stiffness, slow movements and difficulty maintaining balance) common in Parkinson's disease. (such as Lewy body disease, corticobasal degeneration, progressive supranuclear palsy,  Progressive Supranuclear Palsy, PSPA rare brain disorder diagnosed by the identification of early gait instability and difficulty moving the eyes. PSP is often misdiagnosed because some of its symptoms are very much like those of PD. Although PSP gets progressively worse and there is no effective treatment for it, the disease itself is not directly life-threatening. Binswanger disease and multiple system atrophy).
• Persons with marked tremor,  TremorShaking or rhythmic movement, especially in the hands but in other parts of the body. Often occurs when at rest, such as in the RESTING TREMOR. dyskinesia  DyskinesiaTwisting, turning or other abnormal involuntary movement usually involving the arms, legs, trunk, and head. It is most commonly associated with long-term use of levodopa. (difficulty performing voluntary movements) or sensory disturbance.
• Persons who are unable to refrain from anti-parkinsonian medications for up to 15 hours on study days.
• Persons with significant hearing loss.
• Persons with cardiac pacemakers, intracardiac lines, or an implanted medication pump.
• Persons with blood vessel, cochlear, or eye implants.
• Persons with increased intracranial pressure as evaluated by clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. means.
• Persons with metal in the cranium.
• Persons with dental braces (but dental fillings are okay), metal fragments from occupational exposure, or surgical clips in or near the brain.
• Persons who have undergone subthalamic nucleus (deep brain) stimulation or pallidotomy (a surgical procedure in which a part of the brain called the globus pallidus is lesioned or destroyed to improve symptoms of tremor, rigidity,  RigidityA symptom in which muscles feel stiff and display resistance to movement even when another person tries to move the affected part of the body. and bradykinesia)  BradykinesiaSlowness of movement. .

Enrollment

Expected Enrollment: 24 (US)
Date Enrollment Began: Nov 01 2006
Last Updated Date: Apr 24 2007
Trial Post Date: Apr 24 2007
Website: http://clinicaltrials.gov/ct/show/NCT00396942?order=1

Primary Contacts and Locations

Maryland

• Patient Recruitment and Public Liaison Office
  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
  prpl@mail.cc.nih.gov
  Phone: (800) 411-1222
  9000 Rockville Pike
  Rockville Pike, MD 20892
  USA