Brain-controlled Spinal Cord Stimulation in Patients With Spinal Cord Injury

NCT04632290 | Active Not Recruiting DMC

• 1 other identifier: STIMO-BSI
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

In a current first-in-human study, called Stimulation Movement Overground (STIMO, NCT02936453), Epidural Electrical Stimulation (EES) of the spinal cord is applied to enable individuals with chronic severe spinal cord injury (SCI) to complete intensive locomotor neurorehabilitation training. In this clinical feasibility study, it was demonstrated that EES results in an immediate enhancement of walking function, and that when applied repeatedly as part of a neurorehabilitation program, EES can improve leg motor control and trigger neurological recovery in individuals with severe SCI to a certain extent (Wagner et al. 2018). Preclinical studies showed that linking brain activity to the onset and modulation of spinal cord stimulation protocols not only improves the usability of the stimulation, but also augments neurological recovery. Indeed, rats rapidly learned to modulate their cortical activity in order to adjust the amplitude of spinal cord stimulation protocols. This brain-spine interface allowed them to increase the amplitude of the movement of their otherwise paralyzed legs to climb up a staircase (Bonizzato et al. 2018). Moreover, gait rehabilitation enabled by this brain-spine interface (BSI) augmented plasticity and neurological recovery. When EES was correlated with cortical neuron activity during training, rats showed better recovery than when training was only supported by continuous stimulation (Bonizzato et al. 2018). This concept of brain spine-interface was validated in non-human primates (Capogrosso et al. 2016). Clinatec (Grenoble, France) has developed a fully implantable electrocorticogram (ECoG) recording device with a 64-channel epidural electrode array capable of recording electrical signals from the motor cortex for an extended period of time and with a high signal to noise ratio the electrical signals from the motor cortex. This ECoG-based system allowed tetraplegic patients to control an exoskeleton (ClinicalTrials.gov, NCT02550522) with up to 8 degrees of freedom for the upper limb control (Benabid et al. 2019). This device was implanted in 2 individuals so far; one of them has been using this system both at the hospital and at home for more than 3 years. We hypothesize that ECoG-controlled EES in individuals with SCI will establish a direct bridge between the patient's motor intention and the spinal cord below the lesion, which will not only improve or restore voluntary control of leg movements, but will also boost neuroplasticity and neurological recovery when combined with neurorehabilitation.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (2)

• Safety Measure

  Number of Adverse Events possibly, probably or causally related to the procedure or device.

  Through study completion, an average of 1 year

• Safety Measure

  Number of device deficiencies

  Through study completion, an average of 1 year

Secondary Outcomes (16)

• WISCI II score

  1 week before implantation, 8 weeks and 19 weeks after implantation

• 10mWT

  1 week before implantation, 8 weeks and 19 weeks after implantation

• Weight bearing capacity

  1 week before implantation, 8 weeks and 19 weeks after implantation

• SCIM III score

  1 week before implantation, 8 weeks and 19 weeks after implantation

• 6minWT

  1 week before implantation, 8 weeks and 19 weeks after implantation

Study Arms (1)

All participants

EXPERIMENTAL

All participants receive the same intervention.

Device: STIMO-BSI system implantation; Device: ARC-BSI Lumbar System

Interventions

STIMO-BSI system implantation DEVICE

Participants are implanted bilaterally with epidural electrocorticography devices. The decoded motor intentions are driving the implanted spinal cord stimulation system. Brain-controlled spinal cord stimulation is used for training and rehabilitation to recover voluntary movements.

All participants

ARC-BSI Lumbar System DEVICE

ARC-BSI Lumbar System for participants entering the optional extension with system upgrade: replacement of the neurostimulator, and upgrade of the WIMAGINE system and STIMO system wearable devices.

All participants

Eligibility Criteria

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

You may qualify if:

• Having completed the main phase of the STIMO study (NCT02936453).
• SCI graded as American Spinal Injury Association Impairment Scale (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 60 mm.
• Focal spinal cord disorder caused by either trauma or epidural, subdural or intramedullary bleeding
• Minimum 12 months post-injury
• Completed in-patient rehabilitation program
• Stable medical, physical and psychological condition as considered by Investigators
• Able to understand and interact with the study team in French or English
• Adequate care-giver support and access to appropriate medical care in patient's home community
• Must agree to comply in good faith with all conditions of the study and to attend all required study training and visit
• Must provide and sign the 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 severe autonomic dysreflexia
• Brain damage
• Epilepsy
• Spinal stenosis
• Use of an intrathecal Baclofen pump.
• Any active implanted cardiac device such as pacemaker or defibrillator.
• Any indication that would require diathermy.
• Any indication that would require MRI.
• 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).
• Congenital or acquired lower limb abnormalities (affection of joints and bone).
• Women who are pregnant (pregnancy test obligatory for women of childbearing potential) or breast feeding or not willing to take contraception.
• Known or suspected non-compliance, drug or alcohol abuse.

Sponsors & Collaborators

• Ecole Polytechnique Fédérale de Lausanne: lead

Study Sites (1)

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (4)

• Wagner FB, Mignardot JB, Le Goff-Mignardot CG, Demesmaeker R, Komi S, Capogrosso M, Rowald A, Seanez I, Caban M, Pirondini E, Vat M, McCracken LA, Heimgartner R, Fodor I, Watrin A, Seguin P, Paoles E, Van Den Keybus K, Eberle G, Schurch B, Pralong E, Becce F, Prior J, Buse N, Buschman R, Neufeld E, Kuster N, Carda S, von Zitzewitz J, Delattre V, Denison T, Lambert H, Minassian K, Bloch J, Courtine G. Targeted neurotechnology restores walking in humans with spinal cord injury. Nature. 2018 Nov;563(7729):65-71. doi: 10.1038/s41586-018-0649-2. Epub 2018 Oct 31.

  PMID: 30382197 BACKGROUND

• Capogrosso M, Milekovic T, Borton D, Wagner F, Moraud EM, Mignardot JB, Buse N, Gandar J, Barraud Q, Xing D, Rey E, Duis S, Jianzhong Y, Ko WK, Li Q, Detemple P, Denison T, Micera S, Bezard E, Bloch J, Courtine G. A brain-spine interface alleviating gait deficits after spinal cord injury in primates. Nature. 2016 Nov 10;539(7628):284-288. doi: 10.1038/nature20118.

  PMID: 27830790 BACKGROUND

• Benabid AL, Costecalde T, Eliseyev A, Charvet G, Verney A, Karakas S, Foerster M, Lambert A, Moriniere B, Abroug N, Schaeffer MC, Moly A, Sauter-Starace F, Ratel D, Moro C, Torres-Martinez N, Langar L, Oddoux M, Polosan M, Pezzani S, Auboiroux V, Aksenova T, Mestais C, Chabardes S. An exoskeleton controlled by an epidural wireless brain-machine interface in a tetraplegic patient: a proof-of-concept demonstration. Lancet Neurol. 2019 Dec;18(12):1112-1122. doi: 10.1016/S1474-4422(19)30321-7. Epub 2019 Oct 3.

  PMID: 31587955 BACKGROUND

• Bonizzato M, Pidpruzhnykova G, DiGiovanna J, Shkorbatova P, Pavlova N, Micera S, Courtine G. Brain-controlled modulation of spinal circuits improves recovery from spinal cord injury. Nat Commun. 2018 Aug 1;9(1):3015. doi: 10.1038/s41467-018-05282-6.

  PMID: 30068906 BACKGROUND

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

• Jocelyne Bloch

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 17, 2020
• Study Start: July 4, 2021
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)