A Neuroprosthesis for Seated Posture and Balance

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
VA Office of Research and Development
Study ID
NCT01474148
Status
Recruiting
Apply to this trial

Conditions

  • Paralysis
  • Paraplegia
  • Spinal Cord Injury
  • Tetraplegia

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IRS-8 (8-Channel implanted stimulator-telemeter) — DEVICE
    Surgical implantation of the 8-channel neuroprosthesis

Study Details

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.

Key Dates

Start date
Nov 30, 2011
Status verified
Oct 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

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

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Louis Stokes VA Medical Center, Cleveland, OHClevelandOhio44106-1702
Lisa M Lombardo, MPT
[email protected]
(216) 791-3800
Ronald Triolo, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cleveland, OH

By research site
Louis Stokes VA Medical Center, Cleveland, OH· Cleveland, OH

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