Multiple Sclerosis, Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Conditions
Keywords
paralysis, electrical stimulation, neuroprosthesis, implanted device
Brief summary
By doing this study, investigators hope to learn how electrical stimulation can improve human movement, biomechanics, and function and to gather information on the safety and effectiveness of an implanted electrical stimulation system after paralysis from spinal cord injury, stroke, multiple sclerosis, and traumatic brain injury.
Detailed description
The purpose of this research study is to better understand how people move, so investigators can develop improved ways to help individuals with lower-limb and/or trunk paralysis perform everyday activities such as sitting, reaching, pushing a wheelchair, transferring, standing, stepping, and maintaining balance. This study evaluates how activating stabilizing muscles, either with surface electrical stimulation or with an implanted neural stimulation device may change the way these daily activities are performed and potentially enhance functional independence. A key goal of this project is to collect information on the safety and effectiveness of an implanted neural stimulation system. The U.S. Food and Drug Administration (FDA) permits the limited investigational use of this implanted system for individuals with lower-limb and/or trunk paralysis resulting from neurological conditions.
Interventions
DEVICENeural Prosthesis
implanted electrical stimulation device
Sponsors
Louis Stokes VA Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Skeletal maturity and ability to sign informed consent (\>18 years) * Non-ventilator dependent paralysis resulting from injuries such as: mid cervical/thoracic (C4 or below) spinal cord injuries, poststroke hemiparesis, TBI, or MS, affecting the trunk and/or lower limbs * Innervated and excitable lower extremity and trunk musculature * Adequate social support and stability * Willingness to comply with follow-up procedures * Time post injury greater than six months * Appropriate body habitus (height and weight within acceptable limits as determined by study physician) * Neurologically stable as determined by a physician
Exclusion criteria
* Non-English speaking * Females who are pregnant * Current pressure injuries that would be exacerbated by study activities * Severe contractures or uncontrolled spasticity of any major joint of the upper or lower extremities that results in a fixed deformity that would interfere with study activities * History of spontaneous fractures or other evidence of excessively low bone density * History of vestibular dysfunction, balance problems, or spontaneous falls * Acute and or/untreated orthopedic problems that would prevent a participant from weight bearing or exercising such as a dislocation or fracture. * Acute and/or chronic problems left untreated or not controlled that would put a participant at risk by using stimulation such as cardiac abnormalities, immunological/pulmonary/renal/circulatory compromise, diabetes or hypertension * Presence of a demand pacemaker or cardiac defibrillator * Any other medical or psychological condition that would be a contraindication * Current pressure ulcers * Significant range of motion limitations that would compromise study activities * Body habitus that would compromise study activities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in Max Standing Time | Study completion - an average of 1 year |
| Difference in Max Walking distance | Study completion - an average of 1 year |
Countries
United States
Contacts
CONTACTMaura Malenchek, PTA
CONTACTLisa Lombardo, MPT
Outcome results
None listed