Spinal Cord InjurySTIMO-2NCT04196114
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
A study testing STIMO-2 device implantation in people with Spinal Cord Injury, run by Ecole Polytechnique Fédérale de Lausanne at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- STIMO-2 device implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on Feasibility of Targeted Epidural Spinal Stimulation to Improve MObility Recovery in Patients With Sub-acute Spinal Cord Injury
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
- Being tested
- STIMO-2 device implantation
- Keywords
- spinal cord injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STIMO-2 device implantationDevice
Implantation of SCS lead in epidural space and implantation of neurostimulator in abdominal region
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | All patients implanted. Receives: Device: STIMO-2 device implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
This endpoint will compare each patient's 6mnWT distance at 12 months post Date Of Injury to historical controls.
Measured: Through study completion, until 12 months after injury
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.
Measured: Through study completion, until 12 months after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start1 Feb 2022 (estimated)
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Why it stopped: Study on-hold before first recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ecole Polytechnique Fédérale de Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jocelyne Bloch, Ecole Polytechnique Fédérale de Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196114
- Sponsor's protocol ID
- STIMO-2
- Acronym
- STIMO-2
- Status last verified
- Oct 2023
- First submitted
- 5 Dec 2019
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Feasibility of Targeted Epidural Spinal Stimulation to Improve MObility Recovery in Patients With Sub-acute Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04196114
- Acronym / sponsor ID
- STIMO-2 / STIMO-2
- Conditions
- Spinal Cord Injury
- Keywords
- spinal cord injury
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study on-hold before first recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ecole Polytechnique Fédérale de LausanneUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Device: STIMO-2 device implantationAll patients implanted. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STIMO-2 device implantationImplantation of SCS lead in epidural space and implantation of neurostimulator in abdominal region | Device | All patients |
Primary outcome
Safety Measure: occurence of Serious Adverse Event
Time frame: 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
Time frame: Through study completion, until 12 months after injury
Measure of the absolute and relative usage of TESS (in minutes) during mobility rehabilitation sessions.
2 secondary outcomes
Preliminary effectiveness: assessment of function recovery of leg motor function using the 6 mnWT distance
Time frame: Through study completion, until 12 months after injury
Preliminary effectiveness: mobility assessment using SCIM-III mobility score
Time frame: Through study completion, until 12 months after injury
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STIMO-2 device implantation in people with Spinal Cord Injury, run by Ecole Polytechnique Fédérale de Lausanne at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Measure: occurence of Serious Adverse Event (time frame: Through study completion, until 12 months after injury). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.