Study on Feasibility of Stimulation on the Lumbar Part of the Spinal Cord to Improve Mobility Recovery in Patients With Sub-acute Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
The STIMO-2 study aims to investigate TESS-supported rehabilitation training in sub-acute spinal cord injury (< 6 months post-injury). The primary endpoint of this study is to assess the safety and feasibility of TESS. The preliminary effectiveness of the therapy is the secondary study endpoint. The mobility recovery status of patients, who undergo TESS-supported rehabilitation, will be assessed at 12 months post SCI, compared to their predicted recovery expectations based on standard rehabilitation program

Official Title
-----------------
Study on Feasibility of Targeted Epidural Spinal Stimulation to Improve MObility Recovery in Patients With Sub-acute Spinal Cord Injury

Conditions
-----------------
Spinal Cord Injury

Intervention / Treatment
-----------------
* Device: STIMO-2 device implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria (non-exhaustive list) Patient enrolled in the EMSCI study Age 18 to 70 years old included Focal spinal cord injury due to trauma Patient with history of SCI within the past 6 months (sub-acute SCI) Vertebral lesion T11 or above Psychological condition compatible with study participation Able and willing to fulfil all study procedures Exclusion criteria (non-exhaustive list) Severe or chronic medical disorder pre-existing SCI affecting rehabilitation Active implanted device such as a pacemaker, implantable cardiac defibrillator Inability to follow study procedures, e.g. due to language problems, psychological disorders, dementia Pregnant or breast feeding Participation in other interventional study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All patients<br>All patients implanted. | Device: STIMO-2 device implantation<br>* Implantation of SCS lead in epidural space and implantation of neurostimulator in abdominal region<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Measure: occurence of Serious Adverse Event | Occurrence of Serious Adverse Event that are deemed related or possibly related to study procedure or to study investigational system | Through study completion, until 12 months after injury | 
| Feasibility Measure: use of TESS stimulation (in minutes) for improved mobility | Measure of the absolute and relative usage of TESS (in minutes) during mobility rehabilitation sessions. | Through study completion, until 12 months after injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary effectiveness: assessment of function recovery of leg motor function using the 6 mnWT distance | This endpoint will compare each patient's 6mnWT distance at 12 months post Date Of Injury to historical controls. | Through study completion, until 12 months after injury | 
| Preliminary effectiveness: mobility assessment using SCIM-III mobility score | This endpoint will compare each patient's SCIM-III mobility score at 12 months post Date Of Injury to historical controls. | Through study completion, until 12 months after injury | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spinal cord injury