Feasibility Study for Enhancing Gait Following Stroke With Implanted Microstimulators

NCT01640041 | Completed

• 2 other identifiers: AMF-CP-0004GO70151
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiparesis

Outcome Measures

Primary Outcomes (1)

• 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: 1. Ankle plantar-flexion at Heel Strike 2. Ankle Dorsiflexion during Peak Swing 3. Knee Flexion at Toe Off 4. Knee Flexion Peak Swing 5. Knee Extension at Heel Strike 6. Knee Flexion at Mid Stance

  24 months

Secondary Outcomes (1)

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

  24 months

Study Arms (1)

Implanted

EXPERIMENTAL

All participants.

Device: Radio-frequency Microstiumulator

Interventions

Radio-frequency Microstiumulator DEVICE

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.

Also known as: The specific device name is the Radio Frequency Microstiumlator (RFM) System.

Implanted

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Alfred E. Mann Foundation for Scientific Research: lead
• VA Office of Research and Development: collaborator

Study Sites (1)

VA Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (3)

• 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.

  PMID: 16322492 BACKGROUND

• 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.

  PMID: 15465093 BACKGROUND

• 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.

  PMID: 11732829 BACKGROUND

MeSH Terms

Conditions

Paresis

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Janis J Daly, PhD, MSPT

  Cleveland VA Medical Center

  PRINCIPAL INVESTIGATOR

• Robert Ruff, MD, PhD

  Cleveland VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: July 13, 2012
• Study Start: May 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: January 25, 2017

Record last verified: 2012-07

Locations

US (1)