Back to resultsStudy 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)
Primary Purpose
Spinal Cord Injury
Status
Withdrawn
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
STIMO-2 device implantation
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring spinal cord injury
Eligibility 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
Sites / Locations
- CHUV
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All patients
Arm Description
All patients implanted.
Outcomes
Primary Outcome Measures
Safety Measure: occurence of Serious Adverse Event
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
Measure of the absolute and relative usage of TESS (in minutes) during mobility rehabilitation sessions.
Secondary Outcome Measures
Preliminary effectiveness: assessment of function recovery of leg motor function using the 6 mnWT distance
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
This endpoint will compare each patient's SCIM-III mobility score at 12 months post Date Of Injury to historical controls.
Full Information
NCT ID
NCT04196114
First Posted
December 5, 2019
Last Updated
October 4, 2023
Sponsor
Ecole Polytechnique Fédérale de Lausanne
1. Study Identification
Unique Protocol Identification Number
NCT04196114
Brief Title
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
Acronym
STIMO-2
Official Title
Study on Feasibility of Targeted Epidural Spinal Stimulation to Improve MObility Recovery in Patients With Sub-acute Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Study on-hold before first recruitment
Study Start Date
February 1, 2022 (Anticipated)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ecole Polytechnique Fédérale de Lausanne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
spinal cord injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All patients
Arm Type
Experimental
Arm Description
All patients implanted.
Intervention Type
Device
Intervention Name(s)
STIMO-2 device implantation
Intervention Description
Implantation of SCS lead in epidural space and implantation of neurostimulator in abdominal region
Primary Outcome Measure Information:
Title
Safety Measure: occurence of Serious Adverse Event
Description
Occurrence of Serious Adverse Event that are deemed related or possibly related to study procedure or to study investigational system
Time Frame
Through study completion, until 12 months after injury
Title
Feasibility Measure: use of TESS stimulation (in minutes) for improved mobility
Description
Measure of the absolute and relative usage of TESS (in minutes) during mobility rehabilitation sessions.
Time Frame
Through study completion, until 12 months after injury
Secondary Outcome Measure Information:
Title
Preliminary effectiveness: assessment of function recovery of leg motor function using the 6 mnWT distance
Description
This endpoint will compare each patient's 6mnWT distance at 12 months post Date Of Injury to historical controls.
Time Frame
Through study completion, until 12 months after injury
Title
Preliminary effectiveness: mobility assessment using SCIM-III mobility score
Description
This endpoint will compare each patient's SCIM-III mobility score at 12 months post Date Of Injury to historical controls.
Time Frame
Through study completion, until 12 months after injury
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHUV
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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