NCT00023062

Brief Summary

This study will use transcranial magnetic stimulation (TMS) to explore how the brain controls movement by sending messages to the spinal cord and muscles and what goes wrong with this process in disease. Activity in the motor cortex-the outer part of the brain-will be examined use TMS in patients with Parkinson's disease and in healthy volunteers. Normal volunteers and patients with Parkinson's disease (stage I to III) 21 years of age and older may be eligible for this study. All participants will have transcranial magnetic stimulation. For this procedure, an insulated wire coil is placed on the subject's scalp and a brief electrical current is passed through the coil. This creates a magnetic pulse that passes into the brain and generates very small electrical currents in the cortex, briefly disrupting the function of the brain cells in the stimulated area. This may cause muscle twitching or tingling in the face, jaw or limb. During the stimulation, participants will be asked to tense certain muscles slightly or perform other simple actions. The electrical activity of the muscle will be recorded on a computer through electrodes taped to the skin over the muscle. In most cases, the study will last less than 3 hours. Participants will also fill out questionnaires about aspects of personality and will be tested for their ability to perform certain cognitive (thinking) and movement tasks. Patients with Parkinson's disease will, in addition, be administered the Uniform Parkinson's Disease Rating Scale to measure disease severity. Patients will be requested to stop all Parkinson's disease medications 12 hours before the study. They may resume medications immediately after the study. Patients who so wish may be admitted to the hospital the day or evening before the study while they are off medications and stay there until they feel ready to leave.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2001

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

August 1, 2001

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2001

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
Last Updated

March 4, 2008

Status Verified

August 1, 2003

First QC Date

August 22, 2001

Last Update Submit

March 3, 2008

Conditions

Keywords

Natural HistoryMotor CortexBehaviorHealthy VolunteersMotor ControlParkinson DiseaseParkinson'sHealthy VolunteerHVNormal Control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients:
  • Patients with established, dopa-responsive PD, Hoehn and Yahr stage I-III, age 21 and older will be included.
  • Patients will be recruited from the NINDS HMCS and ETB clinical programs and from the community.
  • Healthy Controls:
  • Healthy controls 21 and older will be recruited through the NIH Clinical Research Volunteer Program and from the community.

You may not qualify if:

  • Persons with surgically or traumatically implanted foreign bodies in the head (other than dental appliances of fillings) that may pose a physical hazard during magnetic stimulation will also be excluded.
  • Patients:
  • Patients with persistent "resting" tremor that precludes testing at rest may be excluded as well as any patient to whom the screening physician makes a judgment that withdrawal of medications poses a significant risk due to immobility or risk of falling.
  • Patients on long-acting dopamine agonists will also be excluded.
  • Patients in Hoehn and Yahr stage IV will also be excluded, since they are least likely to tolerate medication withdrawal and are also unlikely to be able to maintain muscle relaxation for TMS testing.
  • No significant medical or psychiatric illness (other than PD), pregnancy, history of epilepsy, concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs that could lower the seizure threshold or significantly affect cortical excitability.
  • Must not have surgically or traumatically implanted foreign bodies in the head (other than dental appliances or fillings) that may pose a physical hazard during magnetic stimulation.
  • HEALTHY CONTROLS:
  • Ages 21 and older will be recruited through the NIH Clinical Research Volunteer Program (CRVP) and from the community.
  • All individuals will be processed through the CRVP before participating. Recruitment will be focused on optimizing age, sex, educational, and racial matching with patient group. Patients' spouses will be invited to participate.
  • No significant medical or psychiatric illness (other than PD), pregnancy, history of epilepsy, concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs that could lower the seizure threshold or significantly affect cortical excitability.
  • Must not have surgically or traumatically implanted foreign bodies in the head (other than dental appliances or fillings) that may pose a physical hazard during magnetic stimulation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • DeLong MR. Primate models of movement disorders of basal ganglia origin. Trends Neurosci. 1990 Jul;13(7):281-5. doi: 10.1016/0166-2236(90)90110-v.

    PMID: 1695404BACKGROUND
  • Di Lazzaro V, Restuccia D, Oliviero A, Profice P, Ferrara L, Insola A, Mazzone P, Tonali P, Rothwell JC. Magnetic transcranial stimulation at intensities below active motor threshold activates intracortical inhibitory circuits. Exp Brain Res. 1998 Mar;119(2):265-8. doi: 10.1007/s002210050341.

    PMID: 9535577BACKGROUND
  • Greenberg BD, Ziemann U, Cora-Locatelli G, Harmon A, Murphy DL, Keel JC, Wassermann EM. Altered cortical excitability in obsessive-compulsive disorder. Neurology. 2000 Jan 11;54(1):142-7. doi: 10.1212/wnl.54.1.142.

    PMID: 10636140BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseBehavior

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

August 22, 2001

First Posted

August 23, 2001

Study Start

August 1, 2001

Study Completion

August 1, 2003

Last Updated

March 4, 2008

Record last verified: 2003-08

Locations