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
|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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: All patients
All patients implanted.
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.
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
|Lausanne, Vaud, Switzerland, 1011|