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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04196114

Acronym

STIMO-2

Enrollment

Registered

2019-12-12

Start date

2022-02-01

Completion date

2023-03-31

Last updated

2023-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Keywords

spinal cord injury

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

Interventions

DEVICESTIMO-2 device implantation

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safety Measure: occurence of Serious Adverse Event	Through study completion, until 12 months after injury	Occurrence of Serious Adverse Event that are deemed related or possibly related to study procedure or to study investigational system
Feasibility Measure: use of TESS stimulation (in minutes) for improved mobility	Through study completion, until 12 months after injury	Measure of the absolute and relative usage of TESS (in minutes) during mobility rehabilitation sessions.

Secondary

Measure	Time frame	Description
Preliminary effectiveness: assessment of function recovery of leg motor function using the 6 mnWT distance	Through study completion, until 12 months after injury	This endpoint will compare each patient's 6mnWT distance at 12 months post Date Of Injury to historical controls.
Preliminary effectiveness: mobility assessment using SCIM-III mobility score	Through study completion, until 12 months after injury	This endpoint will compare each patient's SCIM-III mobility score at 12 months post Date Of Injury to historical controls.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026