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)

Study on Feasibility of Targeted Epidural Spinal Stimulation to Improve MObility Recovery in Patients With Sub-acute Spinal Cord Injury

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

Study Overview

• Status: Withdrawn
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Device: STIMO-2 device implantation

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • CHUV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Through study completion, until 12 months after injury
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.	Through study completion, until 12 months after injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through study completion, until 12 months after injury
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.	Through study completion, until 12 months after injury

Collaborators and Investigators

• Sponsor: Ecole Polytechnique Fédérale de Lausanne

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2022
• Primary Completion (Estimated): March 31, 2023
• Study Completion (Estimated): March 31, 2023

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: spinal cord injury
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: STIMO-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No