Implant for Walking After Incomplete SCI

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Louis Stokes VA Medical Center
Study ID
NCT06965127
Status
Recruiting
Apply to this trial

Conditions

  • Gait
  • Spinal Cord Injury (SCI)

Eligibility Criteria

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

Interventions

  • NNP-LE — DEVICE
    Networked NeuroProsthesis - Lower Extremity Configuration (NNP-LE) measuring physiologic command signals and delivering neural stimulation to intramuscular and nerve cuff electrodes for trunk and leg muscle assistance.

Study Details

This is a device study that will evaluate the effect of an implanted stimulator on improving walking in people with incomplete spinal cord injury. 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 implanting the device and setting the individual up for system use, creating controllers for walking, and evaluating the effect of the device over a couple years.

Key Dates

Start date
Aug 27, 2025
Status verified
May 2025
Primary completion
Aug 31, 2028
Completion
Aug 31, 2031

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Implantation, controller development and evaluation
    This phase includes installing the device and setting the individual up for use of the system and evaluating the effect of the system on walking ability.

Primary Outcome Measure

Difference in maximum walking distance [ Time Frame: Immediately after the participant is fully trained to use their implanted system ]

Central Contacts

Locations (1)

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
Nathan Makowski, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Louis Stokes Cleveland Veterans Affairs Medical Center· Cleveland, OH

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