Clinical trial NCT01923662: A Neuroprosthesis for Prolonged Standing After SCI Using Multi-Contact Peripheral Nerve Electrodes
Official title: Exploiting Selective Recruitment to Prolong Standing After SCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Paralysis
Tetraplegia
Paraplegia
Keywords: Paraplegia
Tetraplegia
Spinal Cord Injury
FES
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: National Institutes of Health (NIH)
First posted: 2013-08-15
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

Detailed description: Neuroprostheses for standing after SCI currently rely on continuous activation of the hip and knee extensor muscles, which results in rapid fatigue and ultimately compromises elapsed standing time. The primary objective of this study is to improve the performance of neuroprostheses for standing by developing and implementing advanced stimulation paradigms that use multi-contact peripheral nerve electrodes to delay fatigue onset and prolong standing duration. The new stimulation paradigms will take advantage of the ability of multi-contact nerve cuff electrodes to selectively activate independent portions of a muscle, or independent muscles that perform the same action. Such a capability will allow one or more muscles (or parts of the same muscle) to rest while the others continue to contract to keep the knee extended and the user upright. Stimulation waveforms that alternate activation to multiple muscles performing the same function, rather than continuously activate the entire muscle group constantly, should allow muscles to rest and recover from fatiguing contractions.

In addition to these important clinical benefits, the project is also of high impact and significance because the methods to be developed will not be specific to any single electrode technology or stimulation system. Any clinical or therapeutic application that requires a sustained muscular contraction or the production of constant joint torques for prolonged periods of time will benefit from the successful completion of this project.

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

Primary outcomes:
measure: Standing performance in terms of elapsed standing time will be compared across stimulation paradigms for each subject.
timeFrame: 12 months post-rehabilitation
Secondary outcomes:
measure: Body weight distribution on the arms and legs will be compared across stimulation paradigms for each subject.
timeFrame: 12 months post-rehabilitation
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center, Cleveland, OH
state: Ohio
Study officials:
affiliation: Louis Stokes VA Medical Center, Cleveland, OH
name: Ronald Triolo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davis JA Jr, Triolo RJ, Uhlir J, Bieri C, Rohde L, Lissy D, Kukke S. Preliminary performance of a surgically implanted neuroprosthesis for standing and transfers--where do we stand? J Rehabil Res Dev. 2001 Nov-Dec;38(6):609-17.
citation: Davis JA Jr, Triolo RJ, Uhlir JP, Bhadra N, Lissy DA, Nandurkar S, Marsolais EB. Surgical technique for installing an eight-channel neuroprosthesis for standing. Clin Orthop Relat Res. 2001 Apr;(385):237-52. doi: 10.1097/00003086-200104000-00035.
citation: Fisher LE, Tyler DJ, Anderson JS, Triolo RJ. Chronic stability and selectivity of four-contact spiral nerve-cuff electrodes in stimulating the human femoral nerve. J Neural Eng. 2009 Aug;6(4):046010. doi: 10.1088/1741-2560/6/4/046010. Epub 2009 Jul 15.
citation: Fisher LE, Miller ME, Bailey SN, Davis JA Jr, Anderson JS, Rhode L, Tyler DJ, Triolo RJ. Standing after spinal cord injury with four-contact nerve-cuff electrodes for quadriceps stimulation. IEEE Trans Neural Syst Rehabil Eng. 2008 Oct;16(5):473-8. doi: 10.1109/TNSRE.2008.2003390.
citation: Uhlir JP, Triolo RJ, Kobetic R. The use of selective electrical stimulation of the quadriceps to improve standing function in paraplegia. IEEE Trans Rehabil Eng. 2000 Dec;8(4):514-22. doi: 10.1109/86.895955.
citation: Chae J, Kilgore K, Triolo R, Creasey G. Functional neuromuscular stimulation in spinal cord injury. Phys Med Rehabil Clin N Am. 2000 Feb;11(1):209-26, x.
citation: Freeberg MJ, Pinault GCJ, Tyler DJ, Triolo RJ, Ansari R. Chronic nerve health following implantation of femoral nerve cuff electrodes. J Neuroeng Rehabil. 2020 Jul 14;17(1):95. doi: 10.1186/s12984-020-00720-3.