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NCT04196114 | Withdrawn DMC

• 1 other identifier: STIMO-2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Spinal Cord Injury

Keywords

spinal cord injury

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Preliminary effectiveness: assessment of function recovery of leg motor function using the 6 mnWT distance

  Through study completion, until 12 months after injury

• Preliminary effectiveness: mobility assessment using SCIM-III mobility score

  Through study completion, until 12 months after injury

Study Arms (1)

All patients

EXPERIMENTAL

All patients implanted.

Device: STIMO-2 device implantation

Interventions

STIMO-2 device implantation DEVICE

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

All patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ecole Polytechnique Fédérale de Lausanne: lead

Study Sites (1)

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating investigator

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 12, 2019
• Study Start: February 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)