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)
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ClinicalTrials.gov Identifier: NCT04196114 |
Recruitment Status :
Suspended
(Study on-hold before first recruitment)
First Posted : December 12, 2019
Last Update Posted : March 24, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Spinal Cord Injury | Device: STIMO-2 device implantation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Study on Feasibility of Targeted Epidural Spinal Stimulation to Improve MObility Recovery in Patients With Sub-acute Spinal Cord Injury |
Estimated Study Start Date : | February 1, 2022 |
Estimated Primary Completion Date : | March 31, 2023 |
Estimated Study Completion Date : | March 31, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: All patients
All patients implanted.
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Device: STIMO-2 device implantation
Implantation of SCS lead in epidural space and implantation of neurostimulator in abdominal region |
- Safety Measure: occurence of Serious Adverse Event [ Time Frame: Through study completion, until 12 months after injury ]Occurrence of Serious Adverse Event that are deemed related or possibly related to study procedure or to study investigational system
- Feasibility Measure: use of TESS stimulation (in minutes) for improved mobility [ Time Frame: Through study completion, until 12 months after injury ]Measure of the absolute and relative usage of TESS (in minutes) during mobility rehabilitation sessions.
- Preliminary effectiveness: assessment of function recovery of leg motor function using the 6 mnWT distance [ Time Frame: Through study completion, until 12 months after injury ]This endpoint will compare each patient's 6mnWT distance at 12 months post Date Of Injury to historical controls.
- Preliminary effectiveness: mobility assessment using SCIM-III mobility score [ Time Frame: Through study completion, until 12 months after injury ]This endpoint will compare each patient's SCIM-III mobility score at 12 months post Date Of Injury to historical controls.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04196114
Switzerland | |
CHUV | |
Lausanne, Vaud, Switzerland, 1011 |
Responsible Party: | Jocelyne Bloch, Coordinating investigator, Ecole Polytechnique Fédérale de Lausanne |
ClinicalTrials.gov Identifier: | NCT04196114 |
Other Study ID Numbers: |
STIMO-2 |
First Posted: | December 12, 2019 Key Record Dates |
Last Update Posted: | March 24, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
spinal cord injury |
Spinal Cord Injuries Wounds and Injuries Spinal Cord Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System |