Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00387673
Status:
COMPLETED
Last Update Posted:
2017-06-16
First Post:
2006-10-12
Brief Title:
Effect of Prolonged Electrical Stimulation on Neural Plasticity in Spinal Cord Injury
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Effect of Prolonged Electrical Stimulation on Neural Plasticity in SCI
Status:
COMPLETED
Status Verified Date:
2017-05
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:
Electrical stimulation pulses of electricity applied over the skin of your wrist and activity-based hand exercise have been shown to improve motor skill and strength in individuals with stroke and have recently been shown to also have an effect on individuals with spinal cord injury Therefore the purpose of this research study is to investigate whether electrical stimulation alone or electrical stimulation followed by activity-based training produces gains in pinch strength how hard you can squeeze your thumb and pointer finger together and upper extremity function how well your arm and hand can perform activities in individuals with spinal cord injury
Detailed Description:
Spinal cord injury SCI affects 10000 individuals per year in the United States Approximately one half of all individuals with SCI have tetraparesis due to cervical injury Impaired hand function significantly limits the ability of individuals with cervical SCI to perform manual activities of daily living which affects these individuals physically psychologically and socially Preliminary research by this investigator suggests that somatosensory stimulation combined with activity-based training improves hand function and strength in individuals with incomplete cervical SCI Further investigations on these novel techniques are warranted due to the need to establish proven effective rehabilitation techniques that promote recovery of function in individuals with SCI
The purpose of this research study is to 1determine if somatosensory stimulation in the form of prolonged peripheral nerve electrical stimulation can enhance the effect of an upper extremity activity-based training program in individuals with incomplete cervical SCI and if so 2 identify the operative neural mechanisms underlying the changes induced with the application of somatosensory stimulation
The hypotheses of this study are that individuals with incomplete cervical SCI
1 a 6-week period of somatosensory stimulation of the hand either alone or combined with activity-based training will produce improvements in behavioral outcomes that are significantly greater than those produced by activity-based training preceded by a sham stimulation period
2 this behavioral improvement will be associated with greater changes in cortical excitation than will be observed in subjects receiving activity-based training preceded by a sham stimulation period
The specific objectives of this study are to
1 Recruit male and female volunteers with spastic paresis due to incomplete SCI with impaired hand function and randomize subjects into 1 of 3 groups each of which receives 6 weeks of upper extremity training for 3 sessionsweek as follows a somatosensory stimulation of the median ulnar and radial nerves at the level of the wrist 2 hourssession SS group b somatosensory stimulation of the median ulnar and radial nerves at the wrist 2 hourssession followed by an activity-based upper extremity training program 1 hoursession SSABT group and c sham somatosensory stimulation of the median ulnar and radial nerves at the wrist 2 hourssession followed by an activity-based upper extremity training program 1 hoursession ABT group then carry out training in the 3 subject groups simultaneously each group consisting of 2 subjects at a time with 2 sets of subjectsyear over a 2-year period yielding a target sample of 36 subjects
2 Conduct pre-and post-training assessments of behavioral outcomes using Wolf Motor Function Test and Jebsen Taylor Hand Function test to measure upper extremity function hand-held dynamometry to measure pinch grip strength and Semmes-Weinstein Monofilament Testing to measure sensory function
3 Conduct pre-and post-training assessments of supraspinal motor recruitment including motor evoked potential MEP amplitudes in response to transcranial magnetic stimulation and extent and duration of cortical silent period in response to transcranial magnetic stimulation and spinal motoneuron excitability measured by F-wave amplitude and persistence
The purpose of this research study is to 1determine if somatosensory stimulation in the form of prolonged peripheral nerve electrical stimulation can enhance the effect of an upper extremity activity-based training program in individuals with incomplete cervical SCI and if so 2 identify the operative neural mechanisms underlying the changes induced with the application of somatosensory stimulation
The hypotheses of this study are that individuals with incomplete cervical SCI
1 a 6-week period of somatosensory stimulation of the hand either alone or combined with activity-based training will produce improvements in behavioral outcomes that are significantly greater than those produced by activity-based training preceded by a sham stimulation period
2 this behavioral improvement will be associated with greater changes in cortical excitation than will be observed in subjects receiving activity-based training preceded by a sham stimulation period
The specific objectives of this study are to
1 Recruit male and female volunteers with spastic paresis due to incomplete SCI with impaired hand function and randomize subjects into 1 of 3 groups each of which receives 6 weeks of upper extremity training for 3 sessionsweek as follows a somatosensory stimulation of the median ulnar and radial nerves at the level of the wrist 2 hourssession SS group b somatosensory stimulation of the median ulnar and radial nerves at the wrist 2 hourssession followed by an activity-based upper extremity training program 1 hoursession SSABT group and c sham somatosensory stimulation of the median ulnar and radial nerves at the wrist 2 hourssession followed by an activity-based upper extremity training program 1 hoursession ABT group then carry out training in the 3 subject groups simultaneously each group consisting of 2 subjects at a time with 2 sets of subjectsyear over a 2-year period yielding a target sample of 36 subjects
2 Conduct pre-and post-training assessments of behavioral outcomes using Wolf Motor Function Test and Jebsen Taylor Hand Function test to measure upper extremity function hand-held dynamometry to measure pinch grip strength and Semmes-Weinstein Monofilament Testing to measure sensory function
3 Conduct pre-and post-training assessments of supraspinal motor recruitment including motor evoked potential MEP amplitudes in response to transcranial magnetic stimulation and extent and duration of cortical silent period in response to transcranial magnetic stimulation and spinal motoneuron excitability measured by F-wave amplitude and persistence
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