Gait Training Clinical Trial
Official title:
Mechanisms of Training Induced Improvements in Gait Function After Stroke
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
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.
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