NCT02936453

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

Efficacy of Spinal Epidural Electrical Stimulation (EES) in Combination With Robot-assisted Neurorehabilitation in Patients With Spinal Cord Injury (STIMO)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Jocelyne Bloch · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

STIMO is a First-in-Man (FIM) study with the objective 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), as it was previously successfully demonstrated in animals. The study consists of two phases: A. Main study The main study lasts about 8-12 months for each individual participant, from signing informed consent to the final test in the study This period can be divided into 3 distinct phases: * Pre-implant : about 6-8 weeks from informed consent to implant. During this phase, patient will participate during a total of 6 distinct days of evaluations, of which 5 days in Lausanne and 1 day at the assessment center in Zurich. The patient will also participate to 3 weeks of pre-implantation training in a Body Weight Support (BWS) system. * Implant and stimulation optimization: about 6-8 weeks, including the implantation of the epidural lead and the neurostimulator. In this phase, the optimal stimulation parameters will be determined for the flexing and stretching of both legs. During this period, participants need to be present at the CHUV University Hospital in Lausanne 4-5 days per week (lodging can be provided). * Rehabilitation training and final evaluation: 4 days per week of rehabilitation training during a period of 5 months, followed by a final evaluation lasting 4 days in Lausanne and 1 day in Zurich. In this phase, the patients receive intensive overground rehabilitation training using a body weight support device in combination with EES, with the aim of significantly improving their walking capabilities. During this period, participants need to be present at the CHUV University Hospital in Lausanne (lodging can be provided) 4 days per week. Once the patient has shown the ability to stand or walk safely without robotic assistance, he/she is offered the possibility to complement his/her neuro-rehabilitative training using EES outside the robotic environment and rehabilitation room by making use of the Home-use system. B. Optional study extension (3 years) The patient has the possibility to continue his/her neuro-rehabilitative training with the home-use system for an additional period of 3 years after the end of clinical rehabilitation period. During this period, evaluation measures and technical check-ups are made at regular time points. The patient is contacted monthly to ensure a normal training conduct and a safety follow-up. At the end of the protocol, the study aims to make the patients walk better and faster. Improvements are quantified through pre-defined measures assessed prior to implant and at the end of the main study as well as at regular time points during the optional study extension. As this is the first study of its kind, success is not guaranteed. However, the potential benefits outweigh the potential risks.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
PROCEDURE	Device implantation	* Implantation of Specify 5-6-5 lead or Go-2 lead in epidural space * Implantation of Activa RC neurostimulator

Timeline

• Start date: 2016-07-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2016-10-18
• Last updated: 2023-10-17

Locations

1 site across 1 country: Switzerland