Feasibility Study for Enhancing Gait Following Stroke With Implanted Microstimulators

Completed · Not applicable

Conditions studied: Hemiparesis

In brief

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.

Key facts

Study ID

NCT01640041

Run by

The Alfred E. Mann Foundation for Scientific Research

People needed

1

Starts

2008-05-01

Expected to finish

2010-01-01

Last updated by the study team

2017-01-25

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• VA Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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