Implant for Walking After Stroke

NCT05740540 | Recruiting DMC FDA Device

• 1 other identifier: StudyID00000125
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Stroke; Hemiplegia; Gait, Hemiplegic

Outcome Measures

Primary Outcomes (1)

• Difference in Gait speed

  The 10mWT is used to assess walking speed in meters/second (m/s) over a short distance. Gait speed is how we're evaluating whether the advanced controller works better than a simple generic triggering approach.

  baseline, ~18 weeks post implant, ~44 week post implant

Secondary Outcomes (1)

• Difference in Usability Rating Scale (URS)

  baseline, ~18 weeks post implant, ~44-week post implant

Study Arms (1)

Implantation, controller development, and evaluation

EXPERIMENTAL

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.

Device: IRS-8; Device: IST 12 & IST 16

Interventions

IRS-8 DEVICE

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

Implantation, controller development, and evaluation

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).

Implantation, controller development, and evaluation

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 6-months post stroke
• Age 21 to 75 years old
• Able to ambulate, but does not require the assistance of more than one person
• Walk slower than 0.8m/s during a 10m walk test
• Lower extremity Fugl-Meyer Motor Assessment (FMA) \<= 20
• Reduced peak hip, knee and/or ankle range of motion during stance or swing phases
• Modified Ashworth Scale (MAS) \<= 2 at the above joints during passive flexion and extension
• Innervated and excitable lower extremity and trunk musculature
• Appropriate body habitus (height and weight within acceptable limits as determined by study physician)
• Adequate social support and stability
• Willingness to comply with follow-up procedures
• Neurologically stable as determined by a physician

You may not qualify if:

• Non-English speaking
• Significant range of motion limitations (lacking hip extension, etc.)
• History of spontaneous fractures or other evidence of excessively low bone density
• Acute orthopedic problems (severe scoliosis, joint dislocations, etc.)
• Medical complications (cardiac abnormalities, skin breakdowns, uncontrolled seizures, immunological/pulmonary/renal/circulatory compromise, additional neurologic conditions etc.)
• Cardiovascular or pulmonary disease
• Uncontrolled diabetes or hypertension
• Presence of a demand pacemaker or cardiac defibrillator
• Pregnancy
• Complications of stroke that result in an increased risk of falls (apraxia, uncompensated hemineglect, hemianopsia etc.)
• Significant history of repeated falls
• Severely impaired cognition and communication
• Any other medical or psychological condition that would be a contraindication

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• Case Western Reserve University: collaborator
• Louis Stokes VA Medical Center: collaborator
• Cleveland State University: collaborator

Study Sites (2)

Louis Stokes Cleveland Veterans Affairs Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Stroke; Hemiplegia; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nathan Makowski, PhD

  MetroHealth System, Ohio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Lombardo, MPT

CONTACT

216-791-3800; lisa.lombardo2@va.gov

Nathan Makowski

CONTACT

216 791-3800; nmakowski@metrohealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 23, 2023
• Study Start: May 16, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available after study completion
• Access Criteria: De-identified data will be available anyone with access to the NICHD DASH repository

Locations

US (2)