Recruiting

Neuroprostheses

Sponsor:

Case Western Reserve University

Code:

NCT00623389

Conditions

Spinal Cord Injuries

Stroke

Paralysis

Tetraplegia

Paraplegia

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

IST (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 exercise, standing, stepping and/or balance in people with various degrees of paralysis.

Conditions

Spinal Cord Injuries

Stroke

Paralysis

Tetraplegia

Paraplegia

Study ID

NCT00623389

Start date

Jun 1, 2018

Status verified date

Jul, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Phase I Inclusion Criteria

1. Skeletal maturity and ability to sign informed consent (>18 years)
2. Non-ventilator dependent paralysis resulting from injuries such as: mid cervical/thoracic (C4 or below) spinal cord injuries, poststroke hemiparesis, TBI, or MS, affecting the trunk and/or lower limbs
3. Innervated and excitable lower extremity and trunk musculature
4. Adequate social support and stability
5. Willingness to comply with follow-up procedures

Phase I Exclusion Criteria

1. Non-English speaking
2. Females who are pregnant
3. Current pressure injuries that would be exacerbated by study activities
4. Severe contractures or uncontrolled spasticity of any major joint of the upper or lower extremities that results in a fixed deformity that would interfere with study activities
5. History of spontaneous fractures or other evidence of excessively low bone density
6. History of vestibular dysfunction, balance problems, or spontaneous falls
7. Acute and or/untreated orthopedic problems that would prevent a participant from weight bearing or exercising such as a dislocation or fracture.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Implant

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

IST (Implanted Stimulator-Telemeter)

Pre-surgical exercise with surface electrical stimulation, surgery including electrode and IST- implanted pulse generator insertion, exercise and physical therapy with the implanted system, functional training and laboratory assessment of clinical and technical performance.

Primary outcome measure

  • Device reliability and technical performance measuring changes in standing duration from baseline at discharge to 12 months after discharge [ Time Frame: Change from immediately after intervention and 1 year after intervention ]
  • Device reliability and technical performance measuring changes in standing loads from baseline at discharge to 12 months after discharge [ Time Frame: Change from immediately after intervention and 1 year after intervention ]
  • Device reliability and technical performance measuring changes in walking distance from baseline at discharge to 12 months after discharge [ Time Frame: Change from immediately after intervention and 1 year after intervention ]
  • Device reliability and technical performance measuring changes in walking duration from baseline at discharge to 12 months after discharge [ Time Frame: Change from immediately after intervention and 1 year after intervention ]

Central Contacts and Locations

Central contacts

Locations

Louis Stokes Cleveland VA Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

MetroHealth System

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Principal Investigator:

Ronald J Triolo, Ph.D.

More Information

Sponsor

Case Western Reserve University

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Keywords

  • Neurologic disorders
  • Rare disease
  • Spinal cord injuries
  • Stroke
  • Paraplegia
  • Tetraplegia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Western Reserve University on 2026-07-10.