A Neuroprosthesis for Prolonged Standing After SCI Using Multi-Contact Peripheral Nerve Electrodes



Status:Recruiting
Conditions:Hospital, Neurology, Orthopedic
Therapuetic Areas:Neurology, Orthopedics / Podiatry, Other
Healthy:No
Age Range:21 - Any
Updated:2/27/2019
Start Date:April 11, 2013
End Date:April 10, 2020
Contact:Lisa M Lombardo, MPT
Email:Lisa.Lombardo2@va.gov
Phone:(216) 791-3800

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Exploiting Selective Recruitment to Prolong Standing After SCI

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.

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.

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
We found this trial at
1
site
Cleveland, Ohio 44106
Principal Investigator: Ronald Triolo, PhD
Phone: 216-791-3800
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mi
from
Cleveland, OH
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