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STIMO: Epidural Electrical Simulation (EES) With Robot-assisted Rehabilitation in Patients With Spinal Cord Injury.
Sponsor: Jocelyne Bloch
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.
Official title: Efficacy of Spinal Epidural Electrical Stimulation (EES) in Combination With Robot-assisted Neurorehabilitation in Patients With Spinal Cord Injury (STIMO)
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2016-07
Completion Date
2026-07
Last Updated
2023-10-17
Healthy Volunteers
No
Conditions
Interventions
Device implantation
* Implantation of Specify 5-6-5 lead or Go-2 lead in epidural space * Implantation of Activa RC neurostimulator
Locations (1)
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland