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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 5, 2019
First Posted Date  ICMJE December 12, 2019
Last Update Posted Date March 24, 2021
Estimated Study Start Date  ICMJE February 1, 2022
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE Study on Feasibility of Targeted Epidural Spinal Stimulation to Improve MObility Recovery in Patients With Sub-acute Spinal Cord Injury
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE Device: STIMO-2 device implantation
Implantation of SCS lead in epidural space and implantation of neurostimulator in abdominal region
Study Arms  ICMJE Experimental: All patients
All patients implanted.
Intervention: Device: STIMO-2 device implantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: December 10, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2023
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04196114
Other Study ID Numbers  ICMJE STIMO-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Jocelyne Bloch, Ecole Polytechnique Fédérale de Lausanne
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ecole Polytechnique Fédérale de Lausanne
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ecole Polytechnique Fédérale de Lausanne
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP