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

NCT01923662 | Completed Results FDA Device

• 1 other identifier: B1039-R
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury; Paralysis; Tetraplegia; Paraplegia

Keywords

Paraplegia; Tetraplegia; Spinal Cord Injury; FES

Outcome Measures

Primary Outcomes (1)

• Average Standing Performance in Terms of Elapsed Standing Time for All Subjects.

  The investigators will assess standing performance in terms of elapsed standing time. The investigators will also collect data related to subjective impression of stability.

  12 months post-rehabilitation

Secondary Outcomes (1)

• Percentage of Body Weight Distribution on the Legs While Standing With Stimulation.

  12 months post-rehabilitation

Study Arms (1)

Neuroprosthesis

EXPERIMENTAL

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

Interventions

IST-16 (16-Channel implanted stimulator-telemeter DEVICE

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.

Neuroprosthesis

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

Location

Related Publications (7)

• 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.

  PMID: 11767968 BACKGROUND

• 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.

  PMID: 11302320 BACKGROUND

• 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.

  PMID: 19602729 BACKGROUND

• 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.

  PMID: 18990650 BACKGROUND

• 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.

  PMID: 11204043 BACKGROUND

• 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.

  PMID: 10680166 BACKGROUND

• 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.

  PMID: 32664972 DERIVED

Related Links

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

MeSH Terms

Conditions

Spinal Cord Injuries; Paralysis; Quadriplegia; Paraplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ronald J Triolo
• Organization: VAORD

Ronald.Triolo@va.gov

216-791-3800

Study Officials

• Ronald Triolo, PhD

  Louis Stokes VA Medical Center, Cleveland, OH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 15, 2013
• Study Start: April 11, 2013
• Primary Completion: March 18, 2024
• Study Completion: March 18, 2024
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)