Gait Training and Brain Changes in Stroke Patients
|First Received Date ICMJE||June 6, 2006|
|Last Updated Date||April 22, 2008|
|Start Date ICMJE||June 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00334230 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Gait Training and Brain Changes in Stroke Patients|
|Official Title ICMJE||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.
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.
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.
Day 1: fMRI
Day 2: motor testing with TMS
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Bayona NA, Bitensky J, Teasell R. Plasticity and reorganization of the uninjured brain. Top Stroke Rehabil. 2005 Summer;12(3):1-10. Review.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||April 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
May be eligible for this research study if they:
May be eligible for the research study if they:
Exclusion criteria for stroke patients:
Sub-acute stroke patients will be not be eligible for the study if they:
Exclusion criteria for healthy volunteers:
Healthy volunteers will not be eligible for the study if they:
|Ages||18 Years to 80 Years|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00334230|
|Other Study ID Numbers ICMJE||060175, 06-N-0175|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||April 2008|
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