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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 9-11 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).
At the end of the protocol, the study aims to make the patients walk better and faster, however, as this is the first study of its kind, success is not guaranteed.
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 demonstrated successfully in animals.
The study lasts about 9-11 months for each individual participant, from signing informed consent to the final test in the study. The period can be divided in 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.
- 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 4-5 days per week at the CHUV University Hospital in Lausanne (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 improving the walking capabilities of the patient significantly.
During this period, participants need to be present 4 days per week at the CHUV University Hospital in Lausanne (lodging can be provided).
At the end of the protocol, the study aims to make the patients walk better and faster, as is quantified through the pre-defined measures which are assessed prior to implant and at the end of the study.
As this is the first study of its kind, success is not guaranteed, but the potential benefits outweigh over the potential risks.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Spinal Cord Injury
Centre Hospitalier Universitaire Vaudois
Canton de Vaud
Centre Hospitalier Universitaire Vaudois
Published on BioPortfolio: 2016-10-19T02:38:21-0400
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