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

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Brief Title

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

Official Title

Exploiting Selective Recruitment to Prolong Standing After SCI

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.
    


Study Type

Interventional


Primary Outcome

Standing performance in terms of elapsed standing time will be compared across stimulation paradigms for each subject.

Secondary Outcome

 Body weight distribution on the arms and legs will be compared across stimulation paradigms for each subject.

Condition

Spinal Cord Injury

Intervention

IST-16 (16-Channel implanted stimulator-telemeter

Study Arms / Comparison Groups

 Neuroprosthesis
Description:  Eligible subjects will receive an implanted device (IRS-8 or IST-16) and surgically implanted electrodes to excite muscles that move paralyzed muscles. These electrodes are connected to the implanted stimulator that delivers electrical pulses to the nerves. These pulses cause the muscles to contract to perform functional movements or to exercise.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

10

Start Date

April 11, 2013

Completion Date

April 10, 2022

Primary Completion Date

April 10, 2022

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
      

Gender

All

Ages

21 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ronald Triolo, PhD, (216) 791-3800, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01923662

Organization ID

B1039-R


Responsible Party

Sponsor

Study Sponsor

VA Office of Research and Development

Collaborators

 National Institutes of Health (NIH)

Study Sponsor

Ronald Triolo, PhD, Principal Investigator, Louis Stokes VA Medical Center, Cleveland, OH


Verification Date

December 2020