NCT00028379

Brief Summary

Recent studies have demonstrated that electrical stimulation delivered over the skin increases the muscle strength as measured by a dynamometer in chronic stroke patients. We recently also found out that such stimulation enhances the ability of healthy brains to learn faster, enhancing the beneficial effects of the motor training. The purpose of this study is to find out if this stimulation can enhance the ability of stroke patients to experience plastic changes in the brain. It may aid in the development of new strategies for rehabilitation after brain injury in the future. A clinical and neurological exam will be administered. Each patient will participate in three different sessions separated by at least 48 hours: a 2-hour peripheral nerve stimulation to the weak hand, a 2-hour peripheral nerve stimulation to the leg, and no stimulation. The sessions will be randomly ordered. A magnetic resonance imaging scan of the brain will be done as well. Nerve stimulation will be done by transcranial magnetic stimulation (TMS). In TMS, the head is immobilized within a frame. An insulated coil wire is placed on the scalp and brief electrical current passed through it. Participants may be asked to perform movements, do simple tasks, or simply tense muscles. Electrical activity of the muscles will be recorded with a computer. Some experiments may be recorded on videotape. Participants must be stroke patients who have recovered to the point of being able to make thumb movements, and the stroke must have occurred more than 6 months ago.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2001

Longer than P75 for not_applicable

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

December 1, 2001

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 28, 2001

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

March 4, 2008

Status Verified

November 1, 2005

First QC Date

December 27, 2001

Last Update Submit

March 3, 2008

Conditions

Keywords

PlasticityMotor CortexStrokeSomatosensoryHemiparesis

Interventions

Eligibility Criteria

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

You may qualify if:

  • Hemiparetic patients (right or left who had thromboembolic non-hemorrhagic infarction (documented by CT or MRI) more than 6 months before. Patients should have recovered motor function to the point of being able to perform thumb movements.
  • Patients will be recruited from referrals from the community, particularly Baltimore and Washington VA hospitals, and Suburban Hospital as well as stroke clubs. An anatomical MRI scan will be acquired at the NIH if a recent one (within 6 months) is not available.

You may not qualify if:

  • Large hemorrhagic or brain stem stroke.
  • Multiple cerebral lesions with residual deficits.
  • History of head injury with loss of consciousness.
  • History of severe alcohol or drug abuse.
  • History of psychiatric illness.
  • Unstable cardiac dysrhythmia or unresponsive arterial hypertension (greater than 160/100 mmHg).
  • H/o hyperthyroidism.
  • Receiving alpha-adrenergic antagonists or agonists, major/minor tranquilizers, clonidine,prazosin, phenytoin, benzodiazepines, scopolamine, haloperidol, other neuroleptics, barbiturates.
  • Degree of aphasia or cognitive deficit that makes patient unable to give informed consent.
  • Pregnancy, glaucoma, h/o hypersensitivity or idiosyncrasy to sympatomimetic drugs.

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)

  • Aschersleben G, Gehrke J, Prinz W. Tapping with peripheral nerve block. a role for tactile feedback in the timing of movements. Exp Brain Res. 2001 Feb;136(3):331-9. doi: 10.1007/s002210000562.

    PMID: 11243475BACKGROUND
  • Barker AT, Freeston IL, Jalinous R, Jarratt JA. Magnetic stimulation of the human brain and peripheral nervous system: an introduction and the results of an initial clinical evaluation. Neurosurgery. 1987 Jan;20(1):100-9. doi: 10.1097/00006123-198701000-00024.

    PMID: 3808249BACKGROUND
  • Barker AT, Jalinous R, Freeston IL. Non-invasive magnetic stimulation of human motor cortex. Lancet. 1985 May 11;1(8437):1106-7. doi: 10.1016/s0140-6736(85)92413-4. No abstract available.

    PMID: 2860322BACKGROUND

MeSH Terms

Conditions

StrokeParesis

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
NIH

Study Record Dates

First Submitted

December 27, 2001

First Posted

December 28, 2001

Study Start

December 1, 2001

Study Completion

November 1, 2005

Last Updated

March 4, 2008

Record last verified: 2005-11

Locations