STIMO: Epidural Electrical Simulation (EES) With Robot-assisted Rehabilitation in Patients With Spinal Cord Injury. (STIMO)
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|ClinicalTrials.gov Identifier: NCT02936453|
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : January 23, 2017
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.
|Condition or disease||Intervention/treatment|
|Spinal Cord Injury||Procedure: Device implantation|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Spinal Epidural Electrical Stimulation (EES) in Combination With Robot-assisted Neurorehabilitation in Patients With Spinal Cord Injury (STIMO)|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Experimental: All patients
Patients will participate during 9-11 months, during which there will be :
Procedure: Device implantation
- Safety and Preliminary efficacy: Walking Index for Spinal Cord Injury (WISCI II) [ Time Frame: 7 months after implant ]The Walking Index for Spinal Cord Injury is an ordinal scale that has been frequently used in clinical trials as a tool to assess walking function.
- Safety and Preliminary efficacy: 10-Meter Walk Test (10MWT) [ Time Frame: 7 months after implant ]10-Meter Walk Test (10MWT) is commonly used to measure walking speeds during two conditions: comfortable and fast. It yields scores that are valid and reliable for SCI individuals.
- Safety and Preliminary efficacy: Weight Bearing Capacity (WBC). [ Time Frame: 7 months after implant ]Weight-bearing capacity (WBC) is an important outcome to monitor and particularly relevant in patients with severe motor impairments who cannot walk independently.
- Improvement of walking capability: Spinal Cord Independence Measure (SCIM III). [ Time Frame: 7 months after implant ]Spinal Cord Independence Measure (SCIM III) is a test used as a reference tool for the assessment of overall functional ability after SCI.
- Improvement of walking capability: 6-Min Walk Test (6MWT). [ Time Frame: 7 months after implant ]This assessment is a submaximal test that will be used as a global and easy indicator of the locomotor performance.
- ASIA Impairment Scale (AIS) [ Time Frame: 7 months after implant ]The American Spinal Injury Association (ASIA) Standard Neurological Classification of Spinal Cord Injury is a standard method of assessing the neurological status, including motor and sensory evaluations, of a person who has sustained a spinal cord injury.
- Modified Ashworth Scale (MAS) [ Time Frame: 7 months after implant ]The Modified Ashworth Scale is a method for measuring muscle spasticity. It involves manual movement of a limb through its range of motion to passively stretch specific muscle groups.
- Berg Balance Scale (BBS) [ Time Frame: 7 months after implant ]The Berg Balance Scale was developed to measure balance among frail populations with impairment in balance function by assessing the performance of functional tasks with a 14-item scale.
- SF-36-item Short Form Health Survey (SF-36) [ Time Frame: 7 months after implant ]The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.
- Neurobiomechanical recordings [ Time Frame: 7 months after implant ]Neurobiomechanical behavior during different (loco)motor tasks will be recorded with a combination of kinematics, kinetics and EMG data.
- Urodynamic Measurements [ Time Frame: 7 months after implant ]Patients will be assessed by urodynamic measurement using a Triton machine.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02936453
|Contact: Molywan Vat||+41 21 314 12 email@example.com|
|Contact: Jocelyne Bloch, MD||+41 21 314 12 firstname.lastname@example.org|
|Centre Hospitalier Universitaire Vaudois||Recruiting|
|Lausanne, Canton de Vaud, Switzerland, 1011|
|Contact: Jocelyne Bloch, MD +41 21 314 12 93 email@example.com|
|Study Chair:||Grégoire Courtine||Ecole Polytechnique Fédérale de Lausanne|
|Study Chair:||Armin Curt||University Hospital Balgrist, Zuerich|