Brain Controlled Spinal Cord Stimulation In Participants With Spinal Cord Injury For Lower Limb Rehabilitation

NCT06243952 | Recruiting DMC

• 1 other identifier: Think2Go
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to evaluate the preliminary safety and effectiveness of using a cortical recording device (ECoG) combined with lumbar targeted epidural electrical stimulation (EES) of the spinal cord to restore voluntary motor functions of lower limbs in participants with chronic spinal cord injury suffering from mobility impairment. The goal is to establish a direct bridge between the motor intention of the participant and the the spinal cord below the lesion, which should not only improve or restore voluntary control of legs movement and support immediate locomotion, but also promote neurological recovery when combined with neurorehabilitation.

Conditions

Spinal Cord Injuries; Paraplegia

Keywords

Spinal cord stimulation; Brain computer interface; Brain spine interface

Outcome Measures

Primary Outcomes (1)

• Preliminary safety

  Occurrence of Serious Adverse Events (SAE) and Adverse Events (AE) that are deemed related or possibly related to the procedure or to the ARC-BSI Lumbar System.

  Through study completion (implantation up to end of study - average of 1 year)

Secondary Outcomes (13)

• 10 Meters Walk Test (10MWT)

  Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).

• 6 Minutes Walk Test (6MWT)

  Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).

• Timed Up and Go (TUG)

  Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).

• Walking Index for Spinal Cord Injury (WISCI II)

  Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).

• Berg Balance Scale (BBS)

  Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).

Other Outcomes (4)

• WHOQOL-BREF (World Health Organization Quality of Life)

  Pre-implantation (up to 4 weeks before implantation), during BSI configuration (at 4 weeks and and lasting up to 2 weeks), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).

• PIADS (Psychosocial Impact of Assistive Device Scale)

  Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).

• SCIM III (Spinal Cord Independence Measure)

  Pre-implantation (up to 4 weeks before implantation), post-rehabilitation (at 24 weeks and lasting up to 2 weeks) and post-remote follow up (at 1 year and lasting up to 2 weeks).

Study Arms (1)

All participants

EXPERIMENTAL

All participants receive the same intervention.

Device: ARC-BSI Lumbar system

Interventions

ARC-BSI Lumbar system DEVICE

Implantation of a 64 channel - ECoG array over the sensory motor cortex of the lower limbs, combined with an implantation of 16 channel spinal cord stimulation system over the lumbar region. 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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Must provide Informed Consent as documented by signature (Appendix Informed Consent Form) prior to any study-related procedures,
• Must be at least 18 years old and no older than 60 years old at the time of enrolment,
• Must be suffering from non-progressive traumatic 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 have stable medical, physical and psychological condition as considered by the investigator,
• Must be lesioned at T10 or above, based on AIS level determination by the investigator, with preservation of conus function,
• Must have sustained the injury at least 12 months before signing the consent form,
• Must have residual upper limb function (capable of using a manual wheelchair),
• 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.

You may not qualify if:

• Must not be pregnant nor breast feeding,
• Must not have the intention to become pregnant during the course of the study,
• Must not have brain damage,
• Must not have history of epilepsy,
• 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 have any hematological disorders with increased risk for surgical intervention,
• Must not require ventilator support,
• Must not have limitation of walking function based on accompanying (Central Nervous System (CNS)) disorders (systemic malignant disorders, cardiovascular disorders restricting physical training, peripheral nerve disorders),
• Must not suffer from spinal cord injury from other etiology than traumatic (ischemic, tumoral, autoimmune, etc.),
• 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 Magnetic Resonance Imaging (MRI),
• Must not suffer from congenital nor acquired lower limb abnormalities (affection of joints or bones).

Sponsors & Collaborators

• Ecole Polytechnique Fédérale de Lausanne: lead

Study Sites (1)

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (5)

• 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

• 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

• Capogrosso M, Wenger N, Raspopovic S, Musienko P, Beauparlant J, Bassi Luciani L, Courtine G, Micera S. A computational model for epidural electrical stimulation of spinal sensorimotor circuits. J Neurosci. 2013 Dec 4;33(49):19326-40. doi: 10.1523/JNEUROSCI.1688-13.2013.

  PMID: 24305828 BACKGROUND

• Lorach H, Galvez A, Spagnolo V, Martel F, Karakas S, Intering N, Vat M, Faivre O, Harte C, Komi S, Ravier J, Collin T, Coquoz L, Sakr I, Baaklini E, Hernandez-Charpak SD, Dumont G, Buschman R, Buse N, Denison T, van Nes I, Asboth L, Watrin A, Struber L, Sauter-Starace F, Langar L, Auboiroux V, Carda S, Chabardes S, Aksenova T, Demesmaeker R, Charvet G, Bloch J, Courtine G. Walking naturally after spinal cord injury using a brain-spine interface. Nature. 2023 Jun;618(7963):126-133. doi: 10.1038/s41586-023-06094-5. Epub 2023 May 24.

  PMID: 37225984 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

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jocelyne Bloch, MD

  CHUV

  PRINCIPAL INVESTIGATOR

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: Prof.

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

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: February 6, 2024
• Study Start: May 3, 2024
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)