Feasibility Study for Enhancing Gait Following Stroke With Implanted Microstimulators
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. 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.
Hemi-paretic Stroke With Impaired Ambulation.
Device: Radio-frequency Microstiumulator
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Feasibility Study for Enhancing Gait Following Stroke With Implanted Microstimulators|
- Change from baseline to Month 24 of swing phase gait components and knee control during stance phase with 6 gait components. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
The six gait components listed below:
- Ankle plantar-flexion at Heel Strike
- Ankle Dorsiflexion during Peak Swing
- Knee Flexion at Toe Off
- Knee Flexion Peak Swing
- Knee Extension at Heel Strike
- Knee Flexion at Mid Stance
- Change from baseline to Month 24, without stimulation, of four scales and two QOL questionnaires. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
The four scales are:Six Minute Walk Test, Manual Muscle Test, Fugl-Meyer Coordination Scale, and the Ashworth Scale.
The two QOL questionnaires are: Craig Handicap Assessment & Reporting Technique (CHART) and Stroke Impact Scale (SIS):
|Study Start Date:||May 2008|
|Study Completion Date:||January 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
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.
Other Name: The specific device name is the Radio Frequency Microstiumlator (RFM) System.
The primary objective (Aim I) of this study is to evaluate whether the RFM Gait System can restore the capability to perform the components of gait required for safe, functional walking, for patients in the chronic phase after stroke (> 12 months). We will assess the treatment provided by the RFM system at the Cleveland VA compared to the FNS percutaneous Schreiner electrodes and custom-designed controller previously investigated by the investigators.
The similarities between the RFM-based and percutaneous FNS systems will be assessed using six gait components required for the execution of functional, safe gait, which are lower limb strength, coordination, an index of walking endurance, muscle tone, walking speed, and quality of life.
The secondary objective of this study is to test the technological performance and safety of the RFM Gait System. Measures of technology performance and safety include implantation time; anchoring capability at the motor point of the muscle; reliability of the RFMs during use; reliability of electrical performance of the system; comfort of the system (with stimulation off); comfort of the electrical stimulus.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01640041
|United States, Ohio|
|VA Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Janis J Daly, PhD, MSPT||Cleveland VA Medical Center|
|Principal Investigator:||Robert Ruff, MD, PhD||Cleveland VA Medical Center|