STIMO: Epidural Electrical Simulation (EES) With Robot-assisted Rehabilitation in Patients With S… (NCT02936453) | Clinical Trial Compass
CompletedNot Applicable
STIMO: Epidural Electrical Simulation (EES) With Robot-assisted Rehabilitation in Patients With Spinal Cord Injury.
Switzerland12 participantsStarted 2016-07
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-65 (women or men)
* Incomplete SCI graded as AIS A,B,C \& D
* Level of lesion: T10 and above, based on AIS level determination by the PI, with preservation of conus function
* The intact distance between the cone and the lesion must be at least 60mm
* Focal spinal cord disorder caused by either trauma or epidural, subdural or intramedullary bleeding
* Minimum 12 months post-injury
* Completed in-patient rehabilitation program
* Able to stand with walker or 2 crutches
* Stable medical and physical condition as considered by Investigators
* Adequate care-giver support and access to appropriate medical care in patient's home community
* Agree to comply in good faith with all conditions of the study and to attend all required study training and visits
* Must participate in two training sessions before enrolment
* Must provide and sign Informed Consent prior to any study related procedures
Exclusion Criteria:
* Limitation of walking function based on accompanying (CNS) disorders (systemic malignant disorders, cardiovascular disorders restricting physical training, peripheral nerve disorders)
* History of significant autonomic dysreflexia
* Cognitive/brain damage
* Epilepsy
* Patient who has spinal canal stenosis
* Patient who uses an intrathecal Baclofen pump.
* Patient who has any active implanted cardiac device such as pacemaker or defibrillator.
* Patient who has any indication that would require diathermy.
* Patient who has any indication that w…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and Preliminary efficacy: Walking Index for Spinal Cord Injury (WISCI II)
Timeframe: 7 months after implant
2
Safety and Preliminary efficacy: 10-Meter Walk Test (10MWT)
Timeframe: 7 months after implant
3
Safety and Preliminary efficacy: Weight Bearing Capacity (WBC).