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

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

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