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 (STIMO-2)

Ecole Polytechnique Fédérale de Lausanne

Status

Withdrawn

Conditions

Spinal Cord Injury

Treatments

Device: STIMO-2 device implantation

Study type

Interventional

Funder types

Other

Identifiers

NCT04196114

STIMO-2

Details and patient eligibility

About

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

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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