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

NCT02936453 | Active Not Recruiting DMC

• 1 other identifier: STIMO2016
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Spinal Cord Injury

Keywords

Spinal Cord Injury; Epidural Electrical Stimulation; Robot-assisted

Outcome Measures

Primary Outcomes (3)

• 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.

  7 months after implant

• 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.

  7 months after implant

• 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.

  7 months after implant

Secondary Outcomes (2)

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

  7 months after implant

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

  7 months after implant

Other Outcomes (7)

• ASIA Impairment Scale (AIS)

  7 months after implant

• Modified Ashworth Scale (MAS)

  7 months after implant

• Berg Balance Scale (BBS)

  7 months after implant

Study Arms (1)

All patients

EXPERIMENTAL

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.

Procedure: Device implantation

Interventions

Device implantation PROCEDURE

* Implantation of Specify 5-6-5 lead or Go-2 lead in epidural space * Implantation of Activa RC neurostimulator

All patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Jocelyne Bloch: lead
• Ecole Polytechnique Fédérale de Lausanne: collaborator
• Foundation Wings For Life: collaborator

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (8)

• 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.

  PMID: 24713270 BACKGROUND

• 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.

  PMID: 22653117 BACKGROUND

• 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.

  PMID: 21601270 BACKGROUND

• 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.

  PMID: 22654062 BACKGROUND

• 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.

  PMID: 25253676 BACKGROUND

• 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.

  PMID: 26779815 BACKGROUND

• 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.

  PMID: 39446982 DERIVED

• 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.

  PMID: 35132264 DERIVED

Related Links

• Courtine-Lab is a part of the Center for Neuroprosthetic and Brain Mind Institute of the Life Science School at the Swiss Federal Institute of Technology Lausanne (EPFL). The laboratory is headed by Professor Grégoire Courtine.

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Grégoire Courtine

  Ecole Polytechnique Fédérale de Lausanne

  STUDY CHAIR

• Armin Curt

  University Hospital Balgrist, Zuerich

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 18, 2016
• Study Start: July 1, 2016
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)