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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

NCT04196114 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-10-05

No results posted yet for this study

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

Conditions

  • Spinal Cord Injury

Interventions

DEVICE

STIMO-2 device implantation

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

Sponsors & Collaborators

  • Ecole Polytechnique Fédérale de Lausanne

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04196114 on ClinicalTrials.gov