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RECRUITING
NCT05740540
NA

Implant for Walking After Stroke

Sponsor: MetroHealth Medical Center

View on ClinicalTrials.gov

Summary

This is a device study that will evaluate the effect of an implanted stimulator on improving walking in stroke survivors. There are two phases in the study: 1) Screening - this phase determines if the individual is a good candidate to receive an implanted system, 2) Implantation, controller development, and evaluation - this phase includes installing the device and setting the individual up for home use, creating advanced controllers for walking and evaluating the effect of the device over several months.

Official title: Customizable Cooperative Multi-joint Control to Enhance Walking Mobility After Stroke

Key Details

Gender

All

Age Range

21 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2023-05-16

Completion Date

2027-06-30

Last Updated

2025-09-29

Healthy Volunteers

No

Interventions

DEVICE

IRS-8

Implanted Receiver Stimulator (IRS) delivering 8 channels of stimulation. Appropriate for muscle-based (intramuscular or epimysial) electrodes only

DEVICE

IST 12 & IST 16

Implantable Stimulator Telemeter (IST) that provides 12 independent channels of stimulation with the option of 2 channels of bipolar myoelectric signal recording, or 16 independent stimulus channels. Suitable for muscle-based or nerve cuff electrodes such as the CWRU Spiral, Flat Interface Nerve Electrode (FINE) or Composite-Flat Interface Nerve Electrode (C-FINE).

Locations (2)

Louis Stokes Cleveland Veterans Affairs Medical Center

Cleveland, Ohio, United States

MetroHealth Medical Center

Cleveland, Ohio, United States