Feasibility Study for Enhancing Gait Following Stroke With Implanted

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01640041
Study type	Interventional
Source	The Alfred E. Mann Foundation for Scientific Research
Contact
Status	Completed
Phase	N/A
Start date	May 2008
Completion date	January 2010

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01662960` - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke	N/A
Completed	`NCT03780296` - Implementing Technology Enhanced Real Time Action Observation Therapy in Persons With Chronic Stroke	N/A
Recruiting	`NCT03605381` - MORbidity PRevalence Estimate In StrokE
Recruiting	`NCT05163210` - Effectiveness of AOT Based on Virtual Reality in Stroke Rehabilitation.	N/A
Terminated	`NCT04113525` - Transcutaneous Spinal and Peripheral Stimulation and Wrist Robotic Therapy for Patients With Spastic Stroke	N/A
Completed	`NCT01948739` - Brain Machine Interface Control of an Robotic Exoskeleton in Training Upper Extremity Functions in Stroke	N/A
Not yet recruiting	`NCT03237520` - Comparing Virtual Reality Therapy With Modified-CIMT Versus Modified-CIMT Alone in Hemiparetic Children	N/A
Completed	`NCT03080454` - The Role of Trans-spinal Direct Current Stimulation (tsDCS) in Treating Patients With Hand Spasticity After Stroke	Phase 1/Phase 2
Completed	`NCT01651533` - Mental Practice in Chronic, Stroke Induced Hemiparesis	N/A
Suspended	`NCT01519843` - Post Stroke Motor Learning	N/A
Completed	`NCT01106755` - Effects of Ground Level Gait Training With Body Weight Support (BWS) and Functional Electrical Stimulation (FES)	N/A
Active, not recruiting	`NCT00170716` - Safety and Effectiveness of Cortical Stimulation in the Treatment of Stroke Patients With Upper Extremity Hemiparesis	Phase 3
Completed	`NCT04286997` - VARA (Virtual and Augmented Reality Applications in Rehabilitation): Motor Rehabilitation Protocol With GRAIL for Patients Affected by Hemiparesis	N/A
Completed	`NCT05856669` - The Effects of Mirror-Based Virtual Reality Systems and Recalibration Software on Upper Extremity Function in Individuals Experiencing Hemiparesis Post-Stroke	N/A
Recruiting	`NCT05801874` - Gait and Posture Analysis in Hemiparetic Patients Through Optoelectronic Systems, "Smart" Tools and Clinical Evaluation
Recruiting	`NCT05590988` - Sensorimotor Arm Rehabilitation After Stroke	N/A
Completed	`NCT04536987` - Robot Therapy for Rehabilitation of Hand Movement After Stroke	Phase 2
Recruiting	`NCT04694833` - Telerehabilitation Through Serious Games in Virtual Reality in a Stroke Population (AutoRReVi)	N/A
Completed	`NCT03965403` - Upper Extremity Rehabilitation With the BURT Robotic Arm	N/A
Not yet recruiting	`NCT03638570` - Altered Connections in the Spinal Cord to Reduce Hand Impairment After Stroke	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Feasibility Study for Enhancing Gait Following Stroke With Implanted Microstimulators

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms