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

This study is currently recruiting participants.
Verified May 2017 by VA Office of Research and Development
Sponsor:
ClinicalTrials.gov Identifier:
NCT01923662
First Posted: August 15, 2013
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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.

Condition Intervention
Spinal Cord Injury Paralysis Tetraplegia Paraplegia Device: IST-16 (16-Channel implanted stimulator-telemeter

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploiting Selective Recruitment to Prolong Standing After SCI

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Standing performance in terms of elapsed standing time will be compared across stimulation paradigms for each subject. [ Time Frame: 12 months post-rehabilitation ]
    The investigators will assess standing performance in terms of elapsed standing time with various stimulation paradigms. The investigators will also collect data related to subjective impression of stability.


Secondary Outcome Measures:
  • Body weight distribution on the arms and legs will be compared across stimulation paradigms for each subject. [ Time Frame: 12 months post-rehabilitation ]
    Determine the amount of weight on both arms and legs during standing. During standing performance the investigators will also assess standing stability in terms of variations in knee joint angle and location of body center of mass while standing with various stimulation paradigms.


Estimated Enrollment: 10
Actual Study Start Date: April 11, 2013
Estimated Study Completion Date: April 10, 2019
Estimated Primary Completion Date: April 10, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neuroprosthesis
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.
Device: IST-16 (16-Channel implanted stimulator-telemeter
Surgical implantation of IST-16 stimulator and electrodes to stimulate paralyzed muscles. Subjects will receive exercise and physical therapy with the implanted device. Functional training and laboratory assessments of clinical and technical performance will be conducted.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923662


Contacts
Contact: Lisa M Lombardo, MPT (216) 791-3800 ext 4909 Lisa.Lombardo2@va.gov

Locations
United States, Ohio
Louis Stokes VA Medical Center, Cleveland, OH Recruiting
Cleveland, Ohio, United States, 44106
Contact: Lisa M Lombardo, MPT    216-791-3800 ext 4909    Lisa.Lombardo2@va.gov   
Principal Investigator: Ronald Triolo, PhD         
Sponsors and Collaborators
VA Office of Research and Development
National Institutes of Health (NIH)
Investigators
Principal Investigator: Ronald Triolo, PhD Louis Stokes VA Medical Center, Cleveland, OH
  More Information

Additional Information:
Publications:
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.
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.
Triolo RJ, Bieri C, Uhlir J, Kobetic R, Scheiner A, Marsolais EB. Implanted Functional Neuromuscular Stimulation systems for individuals with cervical spinal cord injuries: clinical case reports. Arch Phys Med Rehabil. 1996 Nov;77(11):1119-28.
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.
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.
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.
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. Review.

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01923662     History of Changes
Other Study ID Numbers: B1039-R
First Submitted: August 7, 2013
First Posted: August 15, 2013
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Paraplegia
Tetraplegia
Spinal Cord Injury
FES

Additional relevant MeSH terms:
Quadriplegia
Spinal Cord Injuries
Paralysis
Paraplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neurologic Manifestations
Signs and Symptoms


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