Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334230
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-06
Brief Title:
Gait Training and Brain Changes in Stroke Patients
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Mechanisms of Training Induced Improvements in Gait Function After Stroke
Status:
COMPLETED
Status Verified Date:
2008-04-21
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study conducted in collaboration with the National Rehabilitation Hospital NRH in Washington DC 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 NRHs 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 subjects 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
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 NRHs 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 subjects 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-N-0175 | None | None | None |