Spinal Cord Injury Clinical Trial
Official title:
Effect of Prolonged Electrical Stimulation on Neural Plasticity in SCI
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.
Spinal cord injury (SCI) affects 10,000 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: 1)determine 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 sessions/week, as follows: a)
somatosensory stimulation of the median, ulnar and radial nerves at the level of the
wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and
radial nerves at the wrist (2 hours/session) followed by an activity-based upper
extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory
stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session)
followed by an activity-based upper extremity training program (1 hour/session); 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 subjects/year 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02574572 -
Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury
|
Phase 1 | |
Recruiting |
NCT05941819 -
ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
|
N/A | |
Completed |
NCT05265377 -
Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury
|
N/A | |
Recruiting |
NCT02331979 -
Improving Bladder Function in SCI by Neuromodulation
|
N/A | |
Completed |
NCT02777281 -
Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI
|
N/A | |
Recruiting |
NCT02978638 -
Electrical Stimulation for Continence After Spinal Cord Injury
|
N/A | |
Withdrawn |
NCT02237547 -
Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury
|
Phase 1/Phase 2 | |
Completed |
NCT02262234 -
Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study
|
Phase 1/Phase 2 | |
Completed |
NCT02161913 -
Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers
|
N/A | |
Terminated |
NCT02080039 -
Electrical Stimulation of Denervated Muscles After Spinal Cord Injury
|
N/A | |
Completed |
NCT01642901 -
Zoledronic Acid in Acute Spinal Cord Injury
|
Phase 3 | |
Completed |
NCT01884662 -
Virtual Walking for Neuropathic Pain in Spinal Cord Injury
|
N/A | |
Terminated |
NCT01433159 -
Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury
|
Phase 2 | |
Completed |
NCT01471613 -
Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury
|
Phase 1/Phase 2 | |
Completed |
NCT01467817 -
Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI)
|
N/A | |
Completed |
NCT02149511 -
Longitudinal Morphometric Changes Following SCI
|
||
Terminated |
NCT01005615 -
Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury
|
Phase 1/Phase 2 | |
Completed |
NCT00663663 -
Telephone Intervention for Pain Study (TIPS)
|
N/A | |
Completed |
NCT01086930 -
Early Intensive Hand Rehabilitation After Spinal Cord Injury
|
Phase 3 | |
Completed |
NCT01025609 -
Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury
|