A Neuroprosthesis for Prolonged Standing After SCI Using Multi-Contact Peripheral Nerve Electrodes
Completed · Not applicable
Conditions studied: Spinal Cord Injury, Paralysis, Tetraplegia, Paraplegia
In brief
The purpose of this study is to improve the performance of neuroprosthesis for standing after SCI by developing and testing new advanced methods that use multiple contact peripheral nerve electrodes to slow the onset of fatigue and increase standing duration. The new advanced methods will take advantage of the ability of multiple-contact nerve cuff electrodes to selectively activate portions of a muscle that perform the same action. Alternating activation to multiple muscles (or parts of the same muscle) rather than continuously activation the entire muscle group constantly should allow them to rest and recover from fatiguing contractions. This should allow users to remain upright for longer periods of time to perform activities of daily living, reduce the risk of falls due to fatigue, and increase the potential of receiving the health benefits of standing.
Key facts
- Study ID
- NCT01923662
- Run by
- VA Office of Research and Development
- People needed
- 6
- Starts
- 2013-04-11
- Expected to finish
- 2024-03-18
- Last updated by the study team
- 2025-08-22
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Skeletal maturity (age 21 and above), and ability to sign informed consent
- Paralysis resulting from neurological disorder such as low cervical/thoracic spinal cord injuries (C6-T12)
- Time post injury greater than six months to assure neurological and emotional stability
- Innervated and excitable lower extremity and lumbar trunk musculature
- Absence of acute or chronic psychological problems or chemical dependency
- Range of motion within normal limits, (full extension at the hip and knee, and ability to attain a neutral ankle position)
- Controlled spasticity and absence of hip flexion and adduction spasms
- Appropriate body habitus (BMI within normal range)
- Adequate social support and stability
- Willingness to comply with follow-up procedures.
- Full coverage of the acetabulum and minimal knee and ankle laxity
You may not qualify if…
- History of vestibular dysfunction, balance problems or spontaneous falls.
- Acute orthopaedic problems: severe scoliosis or joint dislocation, severe osteoporosis.
- Acute medical complication: cardiac abnormalities, skin breakdowns, uncontrolled seizures, or immunological, pulmonary/ renal/ circulatory compromise, auto-immune deficiencies, sepsis, active infection, dental caries.
- Diabetes
- Non-English speaking subjects
- Pregnancy
Where it is running
- Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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