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

Not Applicable

Withdrawn

• Conditions: Spinal Cord Injury
• Interventions: Device: STIMO-2 device implantation

• Registration Number: NCT04196114
• Lead Sponsor: Ecole Polytechnique Fédérale de Lausanne

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 available

Study Timeline

• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-12
• Study Start: 2022-02-01
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	STIMO-2 device implantation	All patients implanted.

Primary Outcome Measures

Name	Time	Method
Safety Measure: occurence of Serious Adverse Event	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	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

Name	Time	Method
Preliminary effectiveness: mobility assessment using SCIM-III mobility score	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.
Preliminary effectiveness: assessment of function recovery of leg motor function using the 6 mnWT distance	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.

Trial Locations

Locations (1)

CHUV; 🇨🇭 Lausanne, Vaud, Switzerland