N/A
Completed N=6
A Neuroprosthesis for Prolonged Standing After SCI Using Multi-Contact Peripheral Nerve Electrodes
Spinal Cord Injury · Paralysis · Tetraplegia · Paraplegia
Source: ClinicalTrials.gov NCT01923662 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Average Standing Performance in Terms of Elapsed Standing Time for All Subjects. — 32.6 Minutes
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Standing Performance in Terms of Elapsed Standing Time for All Subjects. |
32.6 | — |
| SECONDARY Percentage of Body Weight Distribution on the Legs While Standing With Stimulation. |
92.7 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01923662). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.