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Spinal Cord InjurySTIMONCT02936453

STIMO: Epidural Electrical Simulation (EES) With Robot-assisted Rehabilitation in Patients With Spinal Cord Injury.

A study testing Device implantation in people with Spinal Cord Injury, run by Jocelyne Bloch at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

STIMO is a First-in-Man (FIM) study to confirm the safety and feasibility of a closed-loop Epidural Electrical Stimulation (EES) in combination with overground robot assisted rehabilitation training for patients with chronic incomplete spinal cord injury (SCI). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Spinal Cord Injury
What is being tested?
Device implantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteSwitzerland
Study dates
Jul 2016to 1 Jul 2026
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-65 (women or men)
  • Incomplete SCI graded as AIS A,B,C \& D
  • Level of lesion: T10 and above, based on AIS level determination by the PI, with preservation of conus function
  • The intact distance between the cone and the lesion must be at least 60mm
  • Focal spinal cord disorder caused by either trauma or epidural, subdural or intramedullary bleeding
  • Minimum 12 months post-injury
Show all 13Show fewer
  • Completed in-patient rehabilitation program
  • Able to stand with walker or 2 crutches
  • Stable medical and physical condition as considered by Investigators
  • Adequate care-giver support and access to appropriate medical care in patient's home community
  • Agree to comply in good faith with all conditions of the study and to attend all required study training and visits
  • Must participate in two training sessions before enrolment
  • Must provide and sign Informed Consent prior to any study related procedures

Who cannot join

  • Limitation of walking function based on accompanying (CNS) disorders (systemic malignant disorders, cardiovascular disorders restricting physical training, peripheral nerve disorders)
  • History of significant autonomic dysreflexia
  • Cognitive/brain damage
  • Epilepsy
  • Patient who has spinal canal stenosis
  • Patient who uses an intrathecal Baclofen pump.
Show all 19Show fewer
  • Patient who has any active implanted cardiac device such as pacemaker or defibrillator.
  • Patient who has any indication that would require diathermy.
  • Patient who has any indication that would require MRI.
  • Patient that have an increased risk for defibrillation
  • Severe joint contractures disabling or restricting lower limb movements.
  • Haematological disorders with increased risk for surgical interventions (increased risk of haemorrhagic events).
  • Participation in another locomotor training study.
  • Congenital or acquired lower limb abnormalities (affection of joints and bone).
  • Women who are pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding or not willing to take contraception.
  • Known or suspected non-compliance, drug or alcohol abuse.
  • Spinal cord lesion due to either a neurodegenerative disease or a tumour.
  • Patient has other anatomic or co-morbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results.
  • Patient is unlikely to survive the protocol follow-up period of 12 months.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, Canton of Vaud, 1011

Other trials in Switzerland

About this study

Official title: Efficacy of Spinal Epidural Electrical Stimulation (EES) in Combination With Robot-assisted Neurorehabilitation in Patients With Spinal Cord Injury (STIMO)

STIMO is a First-in-Man (FIM) study to confirm the safety and feasibility of a closed-loop Epidural Electrical Stimulation (EES) in combination with overground robot assisted rehabilitation training for patients with chronic incomplete spinal cord injury (SCI).

Patients will participate during 8-12 months, during which there will be:

Read more
  • Pre-implant evaluations (6-8 weeks)
  • Device implantation and stimulation optimization (6-8 weeks)
  • Overground rehabilitation training with EES (5-6 months). In the period after implantation, participants need to be present for testing and training, 4 days per week at the CHUV University Hospital in Lausanne (lodging can be provided). It is possible to complement the neuro-rehabilitative training at CHUV with training outside the rehabilitation room by making use of the Home-use system.

At the end of the protocol, the study aims to make the patients walk better and faster. As this is the first study of its kind, success is not guaranteed. However, the potential benefits outweigh the potential risks.

An optional extension of the study up to 3 years is offered. During this period, the patient can continue the training with the Home-use system.

Read the detailed description

STIMO is a First-in-Man (FIM) study with the objective to confirm the safety and feasibility of a closed-loop Epidural Electrical Stimulation (EES) in combination with overground robot assisted rehabilitation training for patients with chronic incomplete spinal cord injury (SCI), as it was previously successfully demonstrated in animals.

The study consists of two phases:

  1. Main study

The main study lasts about 8-12 months for each individual participant, from signing informed consent to the final test in the study This period can be divided into 3 distinct phases:

  • Pre-implant : about 6-8 weeks from informed consent to implant. During this phase, patient will participate during a total of 6 distinct days of evaluations, of which 5 days in Lausanne and 1 day at the assessment center in Zurich. The patient will also participate to 3 weeks of pre-implantation training in a Body Weight Support (BWS) system.
  • Implant and stimulation optimization: about 6-8 weeks, including the implantation of the epidural lead and the neurostimulator. In this phase, the optimal stimulation parameters will be determined for the flexing and stretching of both legs. During this period, participants need to be present at the CHUV University Hospital in Lausanne 4-5 days per week (lodging can be provided).
  • Rehabilitation training and final evaluation: 4 days per week of rehabilitation training during a period of 5 months, followed by a final evaluation lasting 4 days in Lausanne and 1 day in Zurich. In this phase, the patients receive intensive overground rehabilitation training using a body weight support device in combination with EES, with the aim of significantly improving their walking capabilities. During this period, participants need to be present at the CHUV University Hospital in Lausanne (lodging can be provided) 4 days per week.

Once the patient has shown the ability to stand or walk safely without robotic assistance, he/she is offered the possibility to complement his/her neuro-rehabilitative training using EES outside the robotic environment and rehabilitation room by making use of the Home-use system.

  1. Optional study extension (3 years)

The patient has the possibility to continue his/her neuro-rehabilitative training with the home-use system for an additional period of 3 years after the end of clinical rehabilitation period. During this period, evaluation measures and technical check-ups are made at regular time points. The patient is contacted monthly to ensure a normal training conduct and a safety follow-up.

At the end of the protocol, the study aims to make the patients walk better and faster. Improvements are quantified through pre-defined measures assessed prior to implant and at the end of the main study as well as at regular time points during the optional study extension.

As this is the first study of its kind, success is not guaranteed. However, the potential benefits outweigh the potential risks.

Being tested
Device implantation
Keywords
Spinal Cord Injury, Epidural Electrical Stimulation, Robot-assisted
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.

  • Device implantationProcedure or surgery

    • Implantation of Specify 5-6-5 lead or Go-2 lead in epidural space
    • Implantation of Activa RC neurostimulator
Study groups in NCT02936453
Study groupRoleWhat they receive
All patientsExperimentalPatients will participate during 8-12 months, during which there will be : * Pre-implant evaluations (6-8 weeks) * Device implantation and stimulation optimization (6-8 weeks) * Overground rehabilitation training with EES (5-6 months) In the period after implantation participants need to be present at the CHUV University Hospital in Lausanne 4 days per week for testing and training (lodging can be provided). It is possible to complement the neuro-rehabilitative training at CHUV with a training outside the rehabilitation room by making use of the Home-use system. An optional extension of the study up to 3 years is offered. During this period, the patient can continue the training with the Home-use system.
Receives: Procedure: Device implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Preliminary efficacy: Walking Index for Spinal Cord Injury (WISCI II)

    The Walking Index for Spinal Cord Injury is an ordinal scale that has been frequently used in clinical trials as a tool to assess walking function.

    Measured: 7 months after implant

  2. Safety and Preliminary efficacy: 10-Meter Walk Test (10MWT)

    10-Meter Walk Test (10MWT) is commonly used to measure walking speeds during two conditions: comfortable and fast. It yields scores that are valid and reliable for SCI individuals.

    Measured: 7 months after implant

  3. Safety and Preliminary efficacy: Weight Bearing Capacity (WBC).

    Weight-bearing capacity (WBC) is an important outcome to monitor and particularly relevant in patients with severe motor impairments who cannot walk independently.

    Measured: 7 months after implant

Secondary outcomes (2)

  1. Improvement of walking capability: Spinal Cord Independence Measure (SCIM III).

    Spinal Cord Independence Measure (SCIM III) is a test used as a reference tool for the assessment of overall functional ability after SCI.

    Measured: 7 months after implant

  2. Improvement of walking capability: 6-Min Walk Test (6MWT).

    This assessment is a submaximal test that will be used as a global and easy indicator of the locomotor performance.

    Measured: 7 months after implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2016 (estimated)
  2. Study startJul 2016
  3. Primary completion1 Jul 2026
  4. Study completion1 Jul 2026

Resources

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
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02936453
Sponsor's protocol ID
STIMO2016
Acronym
STIMO
Status last verified
Aug 2026
First submitted
12 Oct 2016
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • Angeli CA, Edgerton VR, Gerasimenko YP, Harkema SJ. Altering spinal cord excitability enables voluntary movements after chronic complete paralysis in humans. Brain. 2014 May;137(Pt 5):1394-409. doi: 10.1093/brain/awu038. Epub 2014 Apr 8.

    PubMed 24713270

  • Dominici N, Keller U, Vallery H, Friedli L, van den Brand R, Starkey ML, Musienko P, Riener R, Courtine G. Versatile robotic interface to evaluate, enable and train locomotion and balance after neuromotor disorders. Nat Med. 2012 Jul;18(7):1142-7. doi: 10.1038/nm.2845.

    PubMed 22653117

  • Harkema S, Gerasimenko Y, Hodes J, Burdick J, Angeli C, Chen Y, Ferreira C, Willhite A, Rejc E, Grossman RG, Edgerton VR. Effect of epidural stimulation of the lumbosacral spinal cord on voluntary movement, standing, and assisted stepping after motor complete paraplegia: a case study. Lancet. 2011 Jun 4;377(9781):1938-47. doi: 10.1016/S0140-6736(11)60547-3. Epub 2011 May 19.

    PubMed 21601270

  • van den Brand R, Heutschi J, Barraud Q, DiGiovanna J, Bartholdi K, Huerlimann M, Friedli L, Vollenweider I, Moraud EM, Duis S, Dominici N, Micera S, Musienko P, Courtine G. Restoring voluntary control of locomotion after paralyzing spinal cord injury. Science. 2012 Jun 1;336(6085):1182-5. doi: 10.1126/science.1217416.

    PubMed 22654062

  • Wenger N, Moraud EM, Raspopovic S, Bonizzato M, DiGiovanna J, Musienko P, Morari M, Micera S, Courtine G. Closed-loop neuromodulation of spinal sensorimotor circuits controls refined locomotion after complete spinal cord injury. Sci Transl Med. 2014 Sep 24;6(255):255ra133. doi: 10.1126/scitranslmed.3008325.

    PubMed 25253676

  • Wenger N, Moraud EM, Gandar J, Musienko P, Capogrosso M, Baud L, Le Goff CG, Barraud Q, Pavlova N, Dominici N, Minev IR, Asboth L, Hirsch A, Duis S, Kreider J, Mortera A, Haverbeck O, Kraus S, Schmitz F, DiGiovanna J, van den Brand R, Bloch J, Detemple P, Lacour SP, Bezard E, Micera S, Courtine G. Spatiotemporal neuromodulation therapies engaging muscle synergies improve motor control after spinal cord injury. Nat Med. 2016 Feb;22(2):138-45. doi: 10.1038/nm.4025. Epub 2016 Jan 18.

    PubMed 26779815

  • Carroll AH, Fakhre E, Quinonez A, Tannous O, Mesfin A. An Update on Spinal Cord Injury and Current Management. JBJS Rev. 2024 Oct 24;12(10). doi: 10.2106/JBJS.RVW.24.00124. eCollection 2024 Oct 1.

    PubMed 39446982

  • Rowald A, Komi S, Demesmaeker R, Baaklini E, Hernandez-Charpak SD, Paoles E, Montanaro H, Cassara A, Becce F, Lloyd B, Newton T, Ravier J, Kinany N, D'Ercole M, Paley A, Hankov N, Varescon C, McCracken L, Vat M, Caban M, Watrin A, Jacquet C, Bole-Feysot L, Harte C, Lorach H, Galvez A, Tschopp M, Herrmann N, Wacker M, Geernaert L, Fodor I, Radevich V, Van Den Keybus K, Eberle G, Pralong E, Roulet M, Ledoux JB, Fornari E, Mandija S, Mattera L, Martuzzi R, Nazarian B, Benkler S, Callegari S, Greiner N, Fuhrer B, Froeling M, Buse N, Denison T, Buschman R, Wende C, Ganty D, Bakker J, Delattre V, Lambert H, Minassian K, van den Berg CAT, Kavounoudias A, Micera S, Van De Ville D, Barraud Q, Kurt E, Kuster N, Neufeld E, Capogrosso M, Asboth L, Wagner FB, Bloch J, Courtine G. Activity-dependent spinal cord neuromodulation rapidly restores trunk and leg motor functions after complete paralysis. Nat Med. 2022 Feb;28(2):260-271. doi: 10.1038/s41591-021-01663-5. Epub 2022 Feb 7.

    PubMed 35132264

Questions about this trial

What is this clinical trial studying?

A study testing Device implantation in people with Spinal Cord Injury, run by Jocelyne Bloch 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 13 inclusion and 19 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: finished, as of the sponsor's last update on 5 Aug 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 and Preliminary efficacy: Walking Index for Spinal Cord Injury (WISCI II) (time frame: 7 months after implant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02936453, which also lists 8 linked publications.

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 Aug 2026.

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