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

NCT ID: NCT04196114

Last Updated: 2023-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-03-31

Brief Summary

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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

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Conditions

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Spinal Cord Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All patients

All patients implanted.

Group Type EXPERIMENTAL

STIMO-2 device implantation

Intervention Type DEVICE

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

Interventions

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STIMO-2 device implantation

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ecole Polytechnique Fédérale de Lausanne

OTHER

Sponsor Role lead

Responsible Party

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Jocelyne Bloch

Coordinating investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHUV

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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STIMO-2

Identifier Type: -

Identifier Source: org_study_id

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