Recruiting

Neuroprosthesis

Sponsor:

VA Office of Research and Development

Code:

NCT01474148

Conditions

Spinal Cord Injury

Paralysis

Tetraplegia

Paraplegia

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

IRS-8 (8-Channel implanted stimulator-telemeter)

Study Details

Brief summary:

The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate stability of the trunk and hips. FES involves applying small electric currents to the nerves, which cause the muscles to contract. This study evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.

Conditions

Spinal Cord Injury

Paralysis

Tetraplegia

Paraplegia

Study ID

NCT01474148

Start date

Nov 30, 2011

Status verified date

Oct, 2025

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • C4-T12
  • ASIA Scale A through C
  • Time post injury greater than 6 months
  • Innervated and excitable trunk and pelvis musculature
  • Absence of acute or chronic psychological problems or chemical dependency
  • Range of motion within normal limits
  • Controlled spasticity and absence of hip flexion and adduction spasm
  • Height and weight within normal limits
  • No history of balance problems or spontaneous falls
  • No history of spontaneous fracture or evidence low bone density
  • No acute orthopaedic problems
  • No acute medical complications
  • Adequate social support and stability
  • Able to speak and read English

Exclusion Criteria:

  • Pregnancy
  • Non-English speaking

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Neuroprosthesis

Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in post-operative training and follow-up procedures.

Interventions

IRS-8 (8-Channel implanted stimulator-telemeter)

Surgical implantation of the 8-channel neuroprosthesis

Primary outcome measure

  • Effect of Trunk stimulation on control seated posture, respiration, seated interface pressures, reach ability, seated stability & personal mobility. [ Time Frame: up to 36 months ]

Central Contacts and Locations

Central contacts

Lisa M Lombardo, MPT

(216) 791-3800Lisa.Lombardo2@va.gov

Emily C Johnson, BA

(216) 791-3800emily.johnson17@va.gov

Locations

Louis Stokes VA Medical Center, Cleveland, OH

Recruiting

Cleveland, Ohio, United States, 44106-1702

Contacts

Lisa M Lombardo, MPT

(216) 791-3800Lisa.Lombardo2@va.gov

Principal Investigator:

Ronald Triolo, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Oct 27, 2025

Last verified

Oct, 2025

Keywords

  • paraplegia
  • tetraplegia
  • Spinal cord injured
  • FES

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-10-27.