Implant for Walking After Stroke

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
MetroHealth Medical Center
Study ID
NCT05740540
Status
Recruiting
Apply to this trial

Conditions

  • Gait, Hemiplegic
  • Hemiplegia
  • Stroke

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • IRS-8 — DEVICE
    Implanted Receiver Stimulator (IRS) delivering 8 channels of stimulation. Appropriate for muscle-based (intramuscular or epimysial) electrodes only
  • IST 12 & IST 16 — DEVICE
    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).

Study Details

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.

Key Dates

Start date
May 16, 2023
Status verified
Sep 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: 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.

Primary Outcome Measure

Difference in Gait speed [ Time Frame: baseline, ~18 weeks post implant, ~44 week post implant ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Louis Stokes Cleveland Veterans Affairs Medical CenterClevelandOhio44106
Lisa Lombardo, MPT
[email protected]
216-791-3800
Maura Malenchek, PTA
[email protected]
216-791-3800
MetroHealth Medical CenterClevelandOhio44109
Kristine Hansen, PT
[email protected]
216-957-3584
Nathan Makowski, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cleveland, OH

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Louis Stokes Cleveland Veterans Affairs Medical Center· Cleveland, OHMetroHealth Medical Center· Cleveland, OH

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