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Feasibility Study for Enhancing Gait Following Stroke With Implanted Microstimulators

NCT01640041 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2017-01-25

No results posted yet for this study

Summary

The purpose of this study is to test an innovative, advanced FNS microstimulator technology developed by the Alfred Mann Foundation (Santa Clarita, CA) called, the Radio Frequency Microstimulation (RFM) Gait System that promises to provide FNS training for restoration of functional gait components in a manner at least as efficacious as current investigational FNS systems. The design features of the RFM Gait System are intended to address the problems with the current FNS systems. The RFM implant devices are small enough to be inserted using only a 5 mm incision\[3\]. Because both the electrode (anode and cathode) are contained within the microstimulator, there are no lead wires traversing the skin, joints, or torso/limb junctures. Individual RFMs can be inserted at the motor points and nerves of each of the paretic muscles in the involved limb and coordinated using radio frequency technology.

Conditions

  • Hemiparesis

Interventions

DEVICE

Radio-frequency Microstiumulator

All participants will receive leg implants and will be trained first in the clinical and subsequently perform stimulation-assisted exercises in the home - for an overall duration of 6 months post-implant. Subsequently, exercise programs will continue without stimulation. Patient condition will be assessed at 9, 12 and 24 months post-implant.

Sponsors & Collaborators

  • VA Office of Research and Development

    collaborator FED

  • The Alfred E. Mann Foundation for Scientific Research

    lead OTHER

Principal Investigators

  • Janis J Daly, PhD, MSPT · Cleveland VA Medical Center

  • Robert Ruff, MD, PhD · Cleveland VA Medical Center

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-12-31
Completion
2010-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01640041 on ClinicalTrials.gov