Gait Training and Brain Changes in Stroke Patients
Completed
Conditions studied: Gait Training, Locomotion
In brief
This study, conducted in collaboration with the National Rehabilitation Hospital (NRH) in Washington, D.C., will look at changes in brain activation and brain responses that occur with gait (walking) training. Brain images and responses of healthy subjects are compared with those of patients. Healthy normal volunteers and people who have had a stroke within 3 months of starting the study may be eligible for this study. Candidates must be between 18 and 80 years of age, and patients must participate in NRH's walking study. Stroke patients participate in all three study sessions described below. The first session takes place before patients start the NRH walking training study, the second session takes place at completion of the NRH walking study, and the third session takes place 3 months after completing the NRH study. Healthy control subjects complete only the procedures in session 3. Session 1 Day 1: Neurological examination and questionnaire to evaluate memory and attention. Day 2: Motor testing with transcranial magnetic stimulation (TMS). For this test, a wire coil is held on the subject's scalp. A brief electrical current passes through the coil, creating a magnetic pulse that stimulates the brain. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions to help position the coil properly. The stimulation may cause a twitch in the leg muscles, and the subject may hear a click and feel a pulling sensation on the skin under the coil. Session 2 Day 1: Functional MRI (fMRI). MRI uses a magnetic field and radio waves to produce images of body tissues and organs. The subject lies on a table that can slide in and out of the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. Scanning time varies from 20 minutes to 3 hours, with most scans lasting 45 and 90 minutes. Subjects may be asked to lie still for up to a few minutes at a time and to perform movements of their foot. Day 2: motor testing with TMS. Session 3 Day 1: fMRI Day 2: motor testing with TMS
Key facts
- Study ID
- NCT00334230
- Run by
- National Institute of Neurological Disorders and Stroke (NINDS)
- People needed
- 58
- Starts
- 2006-06-02
- Expected to finish
- 2008-04-21
- Last updated by the study team
- 2017-07-02
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Exclusion criteria for stroke patients:
- Sub-acute stroke patients will be not be eligible for the study if they:
- are unable to perform the behavioral tasks with the non-paretic foot,
- have had more than one stroke,
- have a history of alcohol or drug abuse or severe language disturbances (aphasia)
- have uncontrolled medical problems, such as heart, lung or kidney disease, epilepsy or diabetes mellitus,
- are pregnant. Since the effects of MRI and TMS on fetal development are unknown, women of childbearing age will have pregnancy test prior to the study and pregnant women will be excluded.
- have a cardiac pacemaker, intracardiac lines, implanted medication pumps, neural stimulators, metal in the cranium, with the exception or dental braces in the mouth.
- simultaneous participation in any other intervention protocol for stroke.
- have with serious cognitive deficits (defined as equivalent to a mini-mental state exam score (MMSE) of 23 or less)
- Exclusion criteria for healthy volunteers:
- Healthy volunteers will not be eligible for the study if they:
- are unable to perform the tasks,
- have a history of alcohol or drug abuse or severe language disturbances or serious cognitive deficits,
- have uncontrolled medical problems, such as heart, lung or kidney disease, epilepsy or diabetes mellitus,
- are pregnant. Since the effects of MRI and TMS on fetal development are unknown, women of childbearing age will have pregnancy test prior to the study and pregnant women will be excluded.
- have a cardiac pacemaker, intracardiac lines, implanted medication pumps, neural stimulators, metal in the cranium except in the mouth, dental braces.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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