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STIMO: Epidural Electrical Simulation (EES) With Robot-assisted Rehabilitation in Patients With Spinal Cord Injury.

NCT02936453 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-10-17

No results posted yet for this study

Summary

STIMO is a First-in-Man (FIM) study to confirm the safety and feasibility of a closed-loop Epidural Electrical Stimulation (EES) in combination with overground robot assisted rehabilitation training for patients with chronic incomplete spinal cord injury (SCI).

Patients will participate during 8-12 months, during which there will be:

* Pre-implant evaluations (6-8 weeks)
* Device implantation and stimulation optimization (6-8 weeks)
* Overground rehabilitation training with EES (5-6 months). In the period after implantation, participants need to be present for testing and training, 4 days per week at the CHUV University Hospital in Lausanne (lodging can be provided). It is possible to complement the neuro-rehabilitative training at CHUV with training outside the rehabilitation room by making use of the Home-use system.

At the end of the protocol, the study aims to make the patients walk better and faster. As this is the first study of its kind, success is not guaranteed. However, the potential benefits outweigh the potential risks.

An optional extension of the study up to 3 years is offered. During this period, the patient can continue the training with the Home-use system.

Conditions

  • Spinal Cord Injury

Interventions

PROCEDURE

Device implantation

* Implantation of Specify 5-6-5 lead or Go-2 lead in epidural space * Implantation of Activa RC neurostimulator

Sponsors & Collaborators

  • Ecole Polytechnique Fédérale de Lausanne

    collaborator OTHER

  • Foundation Wings For Life

    collaborator OTHER

  • Jocelyne Bloch

    lead OTHER

Principal Investigators

  • Grégoire Courtine · Ecole Polytechnique Fédérale de Lausanne

  • Armin Curt · University Hospital Balgrist, Zuerich

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02936453 on ClinicalTrials.gov