Evaluation of an Advanced Lower Extremity Neuroprostheses

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Western Reserve University
Study ID
NCT00623389
Status
Recruiting
Apply to this trial

Conditions

  • Paralysis
  • Paraplegia
  • Spinal Cord Injuries
  • Stroke
  • Tetraplegia

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • IST (Implanted Stimulator-Telemeter) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jun 1, 2018
Status verified
Jun 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

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.

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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Louis Stokes Cleveland VA Medical CenterClevelandOhio44106
Lisa M Lombardo, MPT
[email protected]
216-791-3800
Maura Malenchek, PTA
[email protected]
216-791-3800
MetroHealth SystemClevelandOhio44109
Lisa M Lombardo, MPT
[email protected]
216-791-3800
Maura Malenchek, PTA
[email protected]
216-791-3800
Ronald J Triolo, Ph.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cleveland, OH

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Louis Stokes Cleveland VA Medical Center· Cleveland, OHMetroHealth System· Cleveland, OH

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