Study on feasibility of Targeted epidural spinal stimulation to Improve MObility recovery in patients with sub-acute spinal cord injury

Withdrawn

Conditions: Spinal Cord injury
rehabilitation for controlling the legs
10041543
10009720

Registration Number: NL-OMON49181

Lead Sponsor: École Polytechnique Fédérale de Lausanne

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

1. Patient enrolled in the EMSCI study
2. Patient eligible following stratification based on URP model* (see Figure 3)
3. Age 18 to 70 years old included
4. Focal spinal cord injury due to trauma
5. Patient with history of SCI within the past 6 months (sub-acute SCI)
6. Level of lesion (confirmed by MRI):
o vertebral lesion T11 or above, and the distance between the tip of the conus
medullaris and the location of spinal cord damage must be at least 70 mm,
allowing for electrode placement
o and neurological lesion T11 or above, with conus function preserved
7. Psychological condition compatible with study participation
8. Able and willing to fulfil all study procedures

Exclusion Criteria

1. Spinal cord lesion due to neurodegenerative disease, spondylitis, tumor, or
presence of a spinal stenosis
2. Severe or chronic medical disorder pre-existing SCI affecting rehabilitation
3. Active implanted device such as a pacemaker, implantable cardiac
defibrillator or indication that might lead to implantation of such device.
4. Inability to follow study procedures, e.g. due to language problems,
psychological disorders, dementia
5. Hematological disorders with an increased risk of hemorrhagic event during
surgical interventions
6. Permanent artificial ventilation
7. Congenital or acquired lower limb abnormalities (affection of joints and
bone)
8. Known or suspected drug or alcohol abuse
9. Life expectancy of less than 12 months
10. Pregnant or breast feeding
11. Participation in other interventional study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary safety and feasibility outcome of this feasibility study is<br /><br>composed of 2 measures:<br /><br>* The safety measure will report on the number of patients with a Serious<br /><br>Adverse Event that is deemed related or possibly related to study procedure or<br /><br>to study investigational system, from implant surgery until the end of study.<br /><br>The safety population will account for all enrolled patients eligible for<br /><br>implant surgery. Patients enrolled in the study but withdrawn before implant<br /><br>will not account for the safety population.<br /><br>* The feasibility measure will quantify the integration of TESS in standard<br /><br>clinical mobility rehabilitation procedures, as measured by the absolute and<br /><br>relative usage of TESS (in minutes) during mobility rehabilitation sessions. </p><br>

Secondary Outcome Measures