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

N/AWithdrawnNCT04196114

Ecole Polytechnique Fédérale de Lausanne

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Spinal Cord Injury

Interventions

STIMO-2 device implantationDEVICE

Implantation of SCS lead in epidural space and implantation of neurostimulator in abdominal region

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

CHUV

Lausanne, Canton of Vaud, Switzerland

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: Through study completion, until 12 months after injury

Secondary Outcomes

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.

Time frame: 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.

Time frame: Through study completion, until 12 months after injury

Data from ClinicalTrials.gov

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