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Study on-hold before first recruitment
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Experimental | All patients implanted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STIMO-2 device implantation | Device | Implantation of SCS lead in epidural space and implantation of neurostimulator in abdominal region |
|
| 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 |
| 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 |
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Inclusion criteria (non-exhaustive list)
Exclusion criteria (non-exhaustive list)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHUV | Lausanne | Canton of Vaud | 1011 | Switzerland |
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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 |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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