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

Spinal Cord Injury Clinical Trial

— STIMO-2  

Official title:

Study on Feasibility of Targeted Epidural Spinal Stimulation to Improve MObility Recovery in Patients With Sub-acute Spinal Cord Injury

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04196114
• Other study ID #: STIMO-2
• Status: Withdrawn
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: October 2023
• Source: Ecole Polytechnique Fédérale de Lausanne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Device:
• STIMO-2 device implantation
Implantation of SCS lead in epidural space and implantation of neurostimulator in abdominal region

Locations

Country	Name	City	State
Switzerland	CHUV	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Ecole Polytechnique Fédérale de Lausanne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Through study completion, until 12 months after injury
Secondary	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.	Through study completion, until 12 months after injury