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Gait Training and Brain Changes in Stroke Patients

Primary Purpose

Gait Training, Locomotion

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 Gait Training focused on measuring Functional Magnetic Resonance Imaging (fMRI), Transcranial Magnetic Stimulation (TMS), Locomotion, Cortical Reorganization, Rehabilitation, fMRI, Stroke, Healthy Volunteer, HV

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA: 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 EXCLUSION CRITERIA: 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.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2006
Last Updated
June 30, 2017
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00334230
Brief Title
Gait Training and Brain Changes in Stroke Patients
Official Title
Mechanisms of Training Induced Improvements in Gait Function After Stroke
Study Type
Observational

2. Study Status

Record Verification Date
April 21, 2008
Overall Recruitment Status
Completed
Study Start Date
June 2, 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 21, 2008 (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, 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
Detailed Description
OBJECTIVES: The purpose of this protocol is to study the mechanisms underlying the beneficial effects of locomotor training in hemiplegic patients. The locomotor training will be performed under an approved protocol already started at the National Rehabilitation Hospital (NRH). The overall goal of the NRH protocol is to determine whether goal-directed, robotic-assisted gait training is more effective than conventional gait training for facilitating the recovery of stable walking patterns in hemiparetic stroke patients. We will use functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS) to identify changes in neural networks involved in performance improvements associated with the locomoter training. The relative contribution of somatosensory cortices (SI, SII) to these performance improvements has not been studied. SI and SII have key roles in both storing and processing sensory information. Activity in the somatosensory cortex is significantly involved in controlling sensory input relevant to motor learning in health and disease. For example, stroke patients with decreased sensation exhibit less recovery than those with intact sensation. Sensory input is thought to play a crucial role in performance improvements associated with locomotor learning. Therefore, it is likely that SI and SII activity plays a major contributory role in training-dependent locomotor improvement after stroke. Electrophysiological measurements can provide important insights into sensorimotor integration processes in humans. Indeed, cortical facilitation induced by peripheral nerve afferent input is useful to probe sensorimotor interaction in health and disease. The specific hypotheses are that performance improvements with locomotor training will be associated with: (a) increased sensorimotor integration as expressed by facilitation in MEP size induced by peripheral nerve stimulation, and (b) greater processing in somatosensory regions, expressed as increased fMRI activation in ipsilesional SI and SII.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait Training, Locomotion
Keywords
Functional Magnetic Resonance Imaging (fMRI), Transcranial Magnetic Stimulation (TMS), Locomotion, Cortical Reorganization, Rehabilitation, fMRI, Stroke, Healthy Volunteer, HV

7. Study Design

Enrollment
58 (false)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: 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 EXCLUSION CRITERIA: 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.
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16110423
Citation
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.
Results Reference
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Gait Training and Brain Changes in Stroke Patients

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