STIMO: Epidural Electrical Simulation (EES) With Robot-assisted Rehabilitation in Patients With Spinal Cord Injury.
Key facts
- Who runs it
- Jocelyne Bloch
- Where
- Switzerland1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 12 people enrolled
- Started
- Jul 2016
- Ended
- 1 Jul 2026
- Type of study
- Interventional
- Treatments tested
- Device implantation
- Record updated
- 5 August 2026
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
- 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 take part
- Known or suspected non-compliance, drug or alcohol abuse
- 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
- Epilepsy
- Patient who has any active implanted cardiac device such as pacemaker or defibrillator
- Haematological disorders with increased risk for surgical interventions (increased risk of haemorrhagic events)
- 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
- Cognitive/brain damage
- Patient who has spinal canal stenosis
- Patient who uses an intrathecal Baclofen pump
- 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
- 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
- Patient is unlikely to survive the protocol follow-up period of 12 months
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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).
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Patients 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 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.
The group in the trial
- All patientsTreatment being tested
Patients 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.
Treatment: Device implantation
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Efficacy of Spinal Epidural Electrical Stimulation (EES) in Combination With Robot-assisted Neurorehabilitation in Patients With Spinal Cord Injury (STIMO)
- Record updated
- 5 August 2026