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Feasibility Study for Enhancing Gait Following Stroke With Implanted Microstimulators

Primary Purpose

Hemiparesis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Radio-frequency Microstiumulator

About this trial

This is an interventional device feasibility trial for Hemiparesis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Cognition intact to give valid informed consent to participate.
Sufficient endurance to participate in rehabilitation sessions.
Ability to follow 2 stage commands, in English.
Medically stable.
Age > 21 years.
Impaired ambulation as follows: inability to flex the knee and ankle in the sagittal plane, in a normal manner so the foot clears the floor, inability to control normal knee angle during single limb weight bearing during stance phase .
Minimum trace (Manual Muscle Test score of 1) contraction of hip, knee, and ankle flexors and extensors under volitional control.
Passive range of motion at hip, knee, ankle normal gait kinematics.
Five degrees (5°) of motion for knee and ankle flexors and extensors produced by muscle stimulation achieved non-invasively with electrical stimulation applied to the skin surface.
At least 12 months post stroke.
Ability to understand the informed consent form in English.
Thigh and lower leg circumference and length ≤ 50th percentile of standard U.S. population morphology measures.*
Participants should be able to walk and keep balance without physical assistance
Response to Surface Stimulation at a trace for tibialis anterior and peronous longus.
Subject with unilateral defects

Exclusion Criteria:

Acute or progressive cardiac, renal, respiratory, neurological disorders or malignancy.
Active psychiatric diagnosis or psychological condition, or active drug/alcohol abuse.
Lower motor neuron damage or radiculopathy.
More than one stroke.
Allergy or contraindication to the anesthesia, Versed, (or comparable substitute).

Sites / Locations

VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implanted

Arm Description

All participants.

Outcomes

Primary Outcome Measures

Change from baseline to Month 24 of swing phase gait components and knee control during stance phase with 6 gait components.

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

Secondary Outcome Measures

Change from baseline to Month 24, without stimulation, of four scales and two QOL questionnaires.

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):

Full Information

NCT ID

NCT01640041

First Posted

June 22, 2011

Last Updated

January 23, 2017

Sponsor

The Alfred E. Mann Foundation for Scientific Research

Collaborators

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT01640041

Brief Title

Feasibility Study for Enhancing Gait Following Stroke With Implanted Microstimulators

Official Title

Feasibility Study for Enhancing Gait Following Stroke With Implanted Microstimulators

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Alfred E. Mann Foundation for Scientific Research

Collaborators

VA Office of Research and Development

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemiparesis

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Implanted

Arm Type

Experimental

Arm Description

All participants.

Intervention Type

Device

Intervention Name(s)

Radio-frequency Microstiumulator

Other Intervention Name(s)

The specific device name is the Radio Frequency Microstiumlator (RFM) System.

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from baseline to Month 24 of swing phase gait components and knee control during stance phase with 6 gait components.

Description

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Change from baseline to Month 24, without stimulation, of four scales and two QOL questionnaires.

Description

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Cognition intact to give valid informed consent to participate. Sufficient endurance to participate in rehabilitation sessions. Ability to follow 2 stage commands, in English. Medically stable. Age > 21 years. Impaired ambulation as follows: inability to flex the knee and ankle in the sagittal plane, in a normal manner so the foot clears the floor, inability to control normal knee angle during single limb weight bearing during stance phase . Minimum trace (Manual Muscle Test score of 1) contraction of hip, knee, and ankle flexors and extensors under volitional control. Passive range of motion at hip, knee, ankle normal gait kinematics. Five degrees (5°) of motion for knee and ankle flexors and extensors produced by muscle stimulation achieved non-invasively with electrical stimulation applied to the skin surface. At least 12 months post stroke. Ability to understand the informed consent form in English. Thigh and lower leg circumference and length ≤ 50th percentile of standard U.S. population morphology measures.* Participants should be able to walk and keep balance without physical assistance Response to Surface Stimulation at a trace for tibialis anterior and peronous longus. Subject with unilateral defects Exclusion Criteria: Acute or progressive cardiac, renal, respiratory, neurological disorders or malignancy. Active psychiatric diagnosis or psychological condition, or active drug/alcohol abuse. Lower motor neuron damage or radiculopathy. More than one stroke. Allergy or contraindication to the anesthesia, Versed, (or comparable substitute).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janis J Daly, PhD, MSPT

Organizational Affiliation

Cleveland VA Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Robert Ruff, MD, PhD

Organizational Affiliation

Cleveland VA Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16322492

Citation

Daly JJ, Roenigk K, Holcomb J, Rogers JM, Butler K, Gansen J, McCabe J, Fredrickson E, Marsolais EB, Ruff RL. A randomized controlled trial of functional neuromuscular stimulation in chronic stroke subjects. Stroke. 2006 Jan;37(1):172-8. doi: 10.1161/01.STR.0000195129.95220.77. Epub 2005 Dec 1.

Results Reference

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PubMed Identifier

15465093

Citation

Daly JJ, Ruff RL. Feasibility of combining multi-channel functional neuromuscular stimulation with weight-supported treadmill training. J Neurol Sci. 2004 Oct 15;225(1-2):105-15. doi: 10.1016/j.jns.2004.07.006.

Results Reference

background

PubMed Identifier

11732829

Citation

Daly JJ, Kollar K, Debogorski AA, Strasshofer B, Marsolais EB, Scheiner A, Snyder S, Ruff RL. Performance of an intramuscular electrode during functional neuromuscular stimulation for gait training post stroke. J Rehabil Res Dev. 2001 Sep-Oct;38(5):513-26.

Results Reference

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Feasibility Study for Enhancing Gait Following Stroke With Implanted Microstimulators

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