Gait Training and Brain Changes in Stroke Patients

NCT00334230 | Completed

• 2 other identifiers: 06017506-N-0175
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gait Training; Locomotion

Keywords

Functional Magnetic Resonance Imaging (fMRI); Transcranial Magnetic Stimulation (TMS); Locomotion; Cortical Reorganization; Rehabilitation; fMRI; Stroke; Healthy Volunteer; HV

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke Patients
• May be eligible for this research study if they:
• qualified for participation in the NRH locomotor protocol
• are between 18 and 80 years old
• have not had any other strokes
• had a stroke more than 3 months ago
• had a stroke that affected one side of the brain
• are able to perform the tasks required in the study with the paretic or non-paretic foot
• are willing and able to give consent
• Healthy Volunteers
• May be eligible for the research study if they:
• are between 18 and 80 years old
• are able to perform the tasks required in the study
• are willing and able to give consent
• a normal physical and neurological examination

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Bayona NA, Bitensky J, Teasell R. Plasticity and reorganization of the uninjured brain. Top Stroke Rehabil. 2005 Summer;12(3):1-10. doi: 10.1310/A422-G91U-Q4HB-86XC.

  PMID: 16110423 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 6, 2006
• First Posted: June 7, 2006
• Study Start: June 2, 2006
• Study Completion: April 21, 2008
• Last Updated: July 2, 2017

Record last verified: 2008-04-21

Locations

US (1)