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History of Changes for Study: NCT04196114
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)
Latest version (submitted March 22, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 10, 2019 None (earliest Version on record)
2 March 22, 2021 Recruitment Status, Study Status, Contacts/Locations and Oversight
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Study NCT04196114
Submitted Date:  December 10, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: STIMO-2
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 (STIMO-2)
Official Title: Study on Feasibility of Targeted Epidural Spinal Stimulation to Improve MObility Recovery in Patients With Sub-acute Spinal Cord Injury
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2019
Overall Status: Not yet recruiting
Study Start: March 31, 2020
Primary Completion: March 31, 2023 [Anticipated]
Study Completion: March 31, 2023 [Anticipated]
First Submitted: December 5, 2019
First Submitted that
Met QC Criteria:
December 10, 2019
First Posted: December 12, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
December 10, 2019
Last Update Posted: December 12, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Ecole Polytechnique Fédérale de Lausanne
Responsible Party: Principal Investigator
Investigator: Jocelyne Bloch
Official Title: Coordinating investigator
Affiliation: Ecole Polytechnique Fédérale de Lausanne
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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
Detailed Description:
Open or close this module Conditions
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 20 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Grégoire Courtine
Telephone: +41 (0)21 693 01 31
Email: stimo2.contact@epfl.ch
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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