NCT00396942

Brief 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. ...

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2006

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2008

Completed
Last Updated

July 2, 2017

Status Verified

October 3, 2008

First QC Date

November 7, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

Electroencephalogram (EEG)Nerve Conduction StudyTranscranial Magnetic Stimulation (TMS)Motor Evoked PotentialParkinson DiseasePDHealthy VolunteerHV

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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. doi: 10.1113/jphysiol.1973.sp010273.

    PMID: 4727084BACKGROUND
  • Buonomano DV, Merzenich MM. Cortical plasticity: from synapses to maps. Annu Rev Neurosci. 1998;21:149-86. doi: 10.1146/annurev.neuro.21.1.149.

    PMID: 9530495BACKGROUND
  • Dan Y, Poo MM. Spike timing-dependent plasticity of neural circuits. Neuron. 2004 Sep 30;44(1):23-30. doi: 10.1016/j.neuron.2004.09.007.

    PMID: 15450157BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 7, 2006

First Posted

November 8, 2006

Study Start

November 2, 2006

Study Completion

October 3, 2008

Last Updated

July 2, 2017

Record last verified: 2008-10-03

Locations