NCT05740540

Implant for Walking After Stroke

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: MetroHealth Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to evaluate the effects of neural stimulation for improving walking after stroke. Participants will undergo surgery to implant a stimulator and electrodes to activate muscles used during walking. The device delivers electrical pulses to the nerves causing the muscles to contract to perform functional movements. The system coordinates assistance based on external sensors. After receiving the implanted device, participants undergo training to use the device to assist walking. Evaluations are completed prior to surgery as well after training and at later follow up sessions.

Conditions

• Stroke
• Hemiplegia
• Gait, Hemiplegic

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2023-05-16
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2023-02-23
• Last updated: 2025-09-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study