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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
Sponsor:
Information provided by (Responsible Party):
Jocelyne Bloch, Ecole Polytechnique Fédérale de Lausanne

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: STIMO-2 device implantation Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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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
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
Contacts and Locations
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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


Locations
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Switzerland
CHUV
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Ecole Polytechnique Fédérale de Lausanne
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jocelyne Bloch, Ecole Polytechnique Fédérale de Lausanne:
spinal cord injury
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System