Brain Controlled Spinal Cord Stimulation in Participants With Cervical Spinal Cord Injury for Upper Limb Rehabilitation

NCT05665998 | Recruiting

• 1 other identifier: UP2
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Cervical spinal cord stimulation can elicit arm and hand movements through recruitment of proprioceptive neurons in the dorsal roots. In participants with cervical spinal cord injury, the spare roots bellow the lesion can be used to reactivate motor function. Decoding of motor intentions can be achieved through implantable electrocorticography (ECoG) devices. In this study, the investigators will use an investigational system using ECoG signal recording over the motor cortex to drive muscle specific electrical epidural spinal cord stimulation (EES). The investigators will assess the safety and preliminary efficacy of this system in 3 participants.

Conditions

Cervical Spinal Cord Injury; Tetraplegia

Keywords

Spinal cord stimulation; Brain computer interface; Brain spine interface

Outcome Measures

Primary Outcomes (1)

• Number of treatment-related serious adverse events (SAEs).

  Through completion of the study 12 months

Secondary Outcomes (9)

• Graded and Redefined Assessment of Strength Sensibility, and Prehension (GRASSP) score

  7 months

• Action Research Arm Test (ARAT) score

  7 months

• Capabilities of the Upper Extremity Test (CUE-T)

  7 months

• Range of Motion (in rad)

  7 months

• Grasp force (in N)

  7 months

Study Arms (1)

ARC-BSI Cervical Rehabilitation

EXPERIMENTAL

Implantation of a neuroprosthetics system composed of an electrocorticography acquisition system (WIMAGINE) and a cervical epidural electrical spinal cord stimulation system (ARC-IM) to restore voluntary arm movements in participants with SCI.

Device: ARC-BSI Cervical system

Interventions

ARC-BSI Cervical system DEVICE

Unilateral implantation of a 64 channel - ECoG array over the sensory motor cortex combined with an implantation of 32 channel spinal cord stimulation system over the cervical region. The system decodes the motor attempts of the participant and translates those intentions into modulation of electrical stimulation.

ARC-BSI Cervical Rehabilitation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* Must provide Informed Consent as documented by signature (Appendix Informed Consent Form), * Must be at least 18 years old and no older than 75 years old at the time of enrolment, * Must be suffering from non-progressive traumatic cervical spinal cord injury, * Must be graded A, B, C, or D in the American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification, * Must have completed primary standard of care rehabilitation, * Must be severely impaired in his upper limb function as determined by the investigator, * Must have sustained the injury at least 6 months before signing the consent form, * Must be able to understand and interact with the study team in French or English, * Must agree to comply in good faith with all conditions of the study and to attend all scheduled appointments, * Must use safe contraception for women of childbearing capacity, * Must not be pregnant nor breast feeding, * Must not have history of severe autonomic dysreflexia, * Must not have brain damage, * Must not have history of epilepsy, * Must not have spinal stenosis, * Must not have gastrointestinal ulcers in the last five years, * Must not have any psychological disorder, * Must not have the intention to become pregnant during the course of the study, * Must not be known or suspected of drug or alcohol abuse, * Must not have participated in another clinical study using drugs or medical devices within the 30 days preceding and during the present study, * Must not have previously been injected with stem cells in the spinal cord, * Must not be the investigator himself, his/her family members, employees or other dependent persons, * Must not have any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations as determined by the Investigator, * Must not have any hematological disorders with increased risk for surgical intervention, * Must not require ventilator support, * Must not suffer from spinal cord injury from other etiology than traumatic (ischemic, tumoral, autoimmune, etc), * Must not be subject to spasms that limit the ability of the subject to participate in the study training as determined by the investigator, * Must not display spinal stenosis or post traumatic damage at location of implantation, * Must not require the use of an intrathecal baclofen pump, * Must not be implanted with a device such as pacemakers or defibrillators, * Must not have any indication that would require an MRI, * Must not suffer from congenital nor acquired upper limb abnormalities (affection of joints or bones).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Ecole Polytechnique Fédérale de Lausanne: lead

Study Sites (1)

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (6)

• 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

• Kathe C, Skinnider MA, Hutson TH, Regazzi N, Gautier M, Demesmaeker R, Komi S, Ceto S, James ND, Cho N, Baud L, Galan K, Matson KJE, Rowald A, Kim K, Wang R, Minassian K, Prior JO, Asboth L, Barraud Q, Lacour SP, Levine AJ, Wagner F, Bloch J, Squair JW, Courtine G. The neurons that restore walking after paralysis. Nature. 2022 Nov;611(7936):540-547. doi: 10.1038/s41586-022-05385-7. Epub 2022 Nov 9.

  PMID: 36352232 BACKGROUND

• 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 BACKGROUND

• Larzabal C, Bonnet S, Costecalde T, Auboiroux V, Charvet G, Chabardes S, Aksenova T, Sauter-Starace F. Long-term stability of the chronic epidural wireless recorder WIMAGINE in tetraplegic patients. J Neural Eng. 2021 Sep 9;18(5). doi: 10.1088/1741-2552/ac2003.

  PMID: 34425566 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

• Lorach H, Charvet G, Bloch J, Courtine G. Brain-spine interfaces to reverse paralysis. Natl Sci Rev. 2022 Jan 18;9(10):nwac009. doi: 10.1093/nsr/nwac009. eCollection 2022 Oct. No abstract available.

  PMID: 36196116 BACKGROUND

MeSH Terms

Conditions

Quadriplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jocelyne Bloch, MD

CONTACT

+41 79 556 29 51; jocelyne.bloch@chuv.ch

Henri Lorach, PhD

CONTACT

+41 77 495 50 48; henri.lorach@epfl.ch

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: Certified neurosurgeon, head of functional neurosurgery

Model Details: single-site, single-arm, non-blinded, non-randomized, interventional

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 27, 2022
• Study Start: May 22, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

CH (1)