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

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.

Study Overview

• Status: Completed
• Conditions: Paralysis; Spinal Cord Injury; Tetraplegia; Paraplegia
• Intervention / Treatment: Device: IST-16 (16-Channel implanted stimulator-telemeter

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
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily C Johnson, BA; Phone Number: 64904 (216) 791-3800; Email: emily.johnson17@va.gov

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-1702
      • Louis Stokes VA Medical Center, Cleveland, OH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standing performance in terms of elapsed standing time will be compared across stimulation paradigms for each subject.	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.	12 months post-rehabilitation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight distribution on the arms and legs will be compared across stimulation paradigms for each subject.	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.	12 months post-rehabilitation

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Ronald Triolo, PhD, Louis Stokes VA Medical Center, Cleveland, OH

Publications and helpful links

General 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. doi: 10.1097/00003086-200104000-00035.
• 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. doi: 10.1109/86.895955.
• 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.
• 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.

Helpful Links

• APT Center is a VA Center of Excellence
• FES Center is VA Center of excellence

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2013
• Primary Completion (Actual): March 18, 2024
• Study Completion (Actual): March 18, 2024

Study Registration Dates

• First Submitted: August 7, 2013
• First Submitted That Met QC Criteria: August 13, 2013
• First Posted (Estimated): August 15, 2013

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Spinal Cord Injury; Tetraplegia; Paraplegia; FES
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Spinal Cord Injuries; Quadriplegia; Paraplegia
• Other Study ID Numbers: B1039-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No