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Motor Learning in Stroke Patients and Healthy Volunteers

Primary Purpose

Stroke, Healthy

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Stroke focused on measuring Stroke, Learning, Plasticity, Motor, Rehabilitation, Premotor, Normal Control, Healthy Volunteer, HV, Motor Learning

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS Age: 18 years to 100 years Normal physical and neurological examinations EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS Contraindications for transcranial magnetic stimulation: pacemaker, implanted medical pump, metal plate in skull, metal objects inside the eye or skull, history of seizures INCLUSION CRITERIA FOR STROKE PATIENTS Age: 18 years to 100 years Single ischemic or hemorrhagic hemispheric stroke at least one year before enrollment in study, confirmed by neuroimaging studies (computerized tomography or magnetic resonance imaging). Ability to perform the Jebsen-Taylor test. EXCLUSION CRITERIA FOR STROKE PATIENTS More than one stroke. Other brain lesions (i.e., traumatic brain injury, brain tumor) or neurological problems (i.e., multiple sclerosis, dementia, Parkinson's disease) Depression or poor motivational capacity Serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 20 or less). Inability to understand instructions for the Jebsen-Taylor test. Uncontrolled medical problems including cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, uncontrolled epilepsy Contraindications for transcranial magnetic stimulation: pacemaker, implanted medical pump, metal plate in skull, metal objects inside the eye or skull, history of seizures

Sites / Locations

  • National Institute of Neurological Disorders and Stroke (NINDS)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 2, 2001
Last Updated
March 3, 2008
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00021710
Brief Title
Motor Learning in Stroke Patients and Healthy Volunteers
Official Title
Motor Learning: Behavioral and Physiologic Studies in Normal Volunteers and Stroke Patients
Study Type
Observational

2. Study Status

Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

Brief Summary
This study will try to elucidate learning processes associated with motor training in the weak arm of stroke patients compared with healthy controls. Results from previous clinical trials indicate that training may enhance motor function in healthy volunteers, and perhaps also in stroke patients, even more than 1 year after the stroke. Normal, healthy volunteers and stroke patients 18 years of age and older may be eligible for this study. Study subjects will have a physical examination and participate in 6 additional clinic visits-training and testing sessions on study days 1, 2, 3, 4 and 5, and a final testing session on day 12. During these sessions, they will perform a series of motor tasks, including writing, picking up objects, turning cards, stacking checkers and moving cans, which will be timed and videotaped. Each session will be divided into blocks of 10 trials for each task, separated by 2-minute rest periods. Before and after training on days 1, 2, 5 and 12, subjects will have transcranial magnetic stimulation (TMS) to determine brain changes associated with learning a motor task. For this procedure, the patient is seated in a comfortable chair, and an insulated wire coil is placed on the scalp or skin. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. These pulses generate very small electrical currents in the brain cortex, briefly disrupting the function of the brain cells in the stimulated area. The stimulation may cause muscle twitching or tingling in the scalp, face, or limb. During the stimulation, the subject may be asked to slightly tense certain muscles or perform other simple actions. Electrical nerve stimulation and electromyography will be done to record muscle responses to stimulation. A nerve is stimulated by placing wires on the skin over the nerve and passing a brief electrical current between the wires. Electromyography involves taping metal electrodes to the skin over the muscle. Before and after each session, subjects' muscle strength will be tested with a pinch gauge. They will also be asked to make a mark on a line drawn on paper, to rate their test performance and levels of attentiveness and fatigue.
Detailed Description
The purpose of this protocol is to characterize dynamics of motor learning over a 5-day period in chronic stroke patients relative to healthy age-matched controls. Motor learning will be assessed by improvements in the Jebsen-Taylor test, a validated tool widely used in rehabilitation that measures upper extremity function. Additionally, we intend to evaluate changes in the excitability of the primary motor cortex associated with learning using transcranial magnetic stimulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Healthy
Keywords
Stroke, Learning, Plasticity, Motor, Rehabilitation, Premotor, Normal Control, Healthy Volunteer, HV, Motor Learning

7. Study Design

Enrollment
78 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS Age: 18 years to 100 years Normal physical and neurological examinations EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS Contraindications for transcranial magnetic stimulation: pacemaker, implanted medical pump, metal plate in skull, metal objects inside the eye or skull, history of seizures INCLUSION CRITERIA FOR STROKE PATIENTS Age: 18 years to 100 years Single ischemic or hemorrhagic hemispheric stroke at least one year before enrollment in study, confirmed by neuroimaging studies (computerized tomography or magnetic resonance imaging). Ability to perform the Jebsen-Taylor test. EXCLUSION CRITERIA FOR STROKE PATIENTS More than one stroke. Other brain lesions (i.e., traumatic brain injury, brain tumor) or neurological problems (i.e., multiple sclerosis, dementia, Parkinson's disease) Depression or poor motivational capacity Serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 20 or less). Inability to understand instructions for the Jebsen-Taylor test. Uncontrolled medical problems including cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, uncontrolled epilepsy Contraindications for transcranial magnetic stimulation: pacemaker, implanted medical pump, metal plate in skull, metal objects inside the eye or skull, history of seizures
Facility Information:
Facility Name
National Institute of Neurological Disorders and Stroke (NINDS)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11154837
Citation
Boyd LA, Winstein CJ. Implicit motor-sequence learning in humans following unilateral stroke: the impact of practice and explicit knowledge. Neurosci Lett. 2001 Jan 26;298(1):65-9. doi: 10.1016/s0304-3940(00)01734-1.
Results Reference
background
PubMed Identifier
2927652
Citation
Bridgers SL, Delaney RC. Transcranial magnetic stimulation: an assessment of cognitive and other cerebral effects. Neurology. 1989 Mar;39(3):417-9. doi: 10.1212/wnl.39.3.417.
Results Reference
background
PubMed Identifier
7650532
Citation
Butefisch C, Hummelsheim H, Denzler P, Mauritz KH. Repetitive training of isolated movements improves the outcome of motor rehabilitation of the centrally paretic hand. J Neurol Sci. 1995 May;130(1):59-68. doi: 10.1016/0022-510x(95)00003-k.
Results Reference
background

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Motor Learning in Stroke Patients and Healthy Volunteers

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