Protocol Number: 07-N-0020

Title:

Evaluation of the Plasticity of the Primary Motor Cortex and Motor Learning in Parkinson's Disease

Number:

07-N-0020

Summary:

This study will compare brain changes in people with Parkinson's disease with those of normal control subjects while they learn motor skills. People with Parkinson's disease sometimes have trouble learning new skills, but it is not known why. This study will use repetitive transcranial magnetic stimulation (rTMS), nerve conduction studies, and electroencephaolography (EEG) to look for differences in the way the brain changes with learning in people with Parkinson's disease.

Healthy normal volunteers and people with Parkinson's disease who are between 21 and 80 years of age may be eligible for this study. Participants undergo the following procedures in five visits to the NIH Clinical Center:

Visit 1

Medical and neurological examination.

Visit 2

Motor training. Participants perform a pinching movement once every other second, timed to a metronome, during rTMS. For TMS, a wire coil is held on the subject's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in the muscles of the face, arm or leg. rTMS involves repeated magnetic pulses delivered in short bursts of impulses.

Visits 3 and 4

Brain physiology studies using rTMS, nerve conduction studies (electrical nerve stimulation) and EEG. A nerve at the subject's wrist is stimulated with electrical impulses to measure the speed with which nerves conduct electrical impulses and the strength of the connection between the nerve and the muscle. rTMS is performed for 20 minutes. The EEG measures the electrical activity of the brain (brain waves). For this test, electrodes (metal discs) are placed on the scalp with a conductive gel and the brain waves are recorded while the subject moves his or her thumb briskly for 20 minutes.

Visit 5

Subjects undergo rTMS for 20 minutes and have an EEG.

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

- Right-handed healthy volunteers (21-80 years old)

- Idiopathic PD confirmed by either the PI or an HMCS physician to establish the diagnosis and rule out any other neurologic condition that might affect cortical plasticity.

- Patients must fulfill categories 1 to 3 of the Modified Hoehn and Yahr Scale in the 'off-medication' state.

EXCLUSION CRITERIA:

- Subjects with a history of neurological disorder that might affect cortical plasticity including head injury with loss of consciousness and epilepsy, current use or a history of alcohol or drug abuse, psychiatric disorders requiring hospitalization, or prolonged treatment such as substance abuse addiction

- Subjects with dementia; mini mental state examination (MMSE) less than 25, frontal assessment battery (FAB) less than 13

- Subjects with other parkinsonian syndromes such as Lewy body disease, corticobasal degeneration, progressive supranuclear palsy, Binswanger disease and multiple system atrophy

- Subjects with marked tremor, dyskinesia or sensory disturbance

- Subject who have been treated with the subthalamic nucleus stimulation and pallidotomy

- Subjects who are unable to refrain from anti-parkinsonian medications for up to 15 hours on study days

- Subjects with significant hearing loss

The following exclusion criteria are due to the use of TMS:

- Subjects with cardiac pacemakers, intracardiac lines, implanted medication pump

-Subjects with blood vessel, cochlear, or eye implants

- Subjects with increased intracranial pressure as evaluated by clinical means

- Subjects with metal in the cranium

- Subjects with dental braces (but dental fillings are okay), metal fragments from occupational exposure or surgical clips in or near the brain

Special Instructions:

Currently Not Provided

Keywords:

Electroencephalogram (EEG)

Nerve Conduction Study

Transcranial Magnetic Stimulation (TMS)

Motor Evoked Potential

Recruitment Keyword(s):

Parkinson Disease

PD

Healthy Volunteer

HV

Condition(s):

Parkinson's Disease

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Neurological Disorders and Stroke

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Bliss TV, Lomo T. Long-lasting potentiation of synaptic transmission in the dentate area of the anaesthetized rabbit following stimulation of the perforant path. J Physiol. 1973 Jul;232(2):331-56. No abstract available.

Buonomano DV, Merzenich MM. Cortical plasticity: from synapses to maps. Annu Rev Neurosci. 1998;21:149-86. Review.

Dan Y, Poo MM. Spike timing-dependent plasticity of neural circuits. Neuron. 2004 Sep 30;44(1):23-30. Review.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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