Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation

NCT07610850 | Recruiting DMC

• 1 other identifier: Stroke-BSI
• 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 cervical and lumbar targeted epidural electrical stimulation (EES) of the spinal cord to restore voluntary motor functions of upper and lower limbs in participants with chronic stroke suffering from mobility impairment. The goal is to establish a direct bridge between the motor intention of the participant and the spinal cord, which should not only improve or restore voluntary control of arm and leg movement and support immediate mobility, but also promote neurological recovery when combined with neurorehabilitation.

Conditions

Stroke; Hemiplegia

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 Stroke System.

  From enrollment until End of the Study timepoint (at 5 years)

Secondary Outcomes (14)

• Fugl-Meyer Assessment Lower Extremities

  Pre-implantation: Baseline (B) Post-implantation (counting from first surgery) :6-Months measures (M6), 1-Year Measures (Y1), then Yearly Measures until 5 years (Y2, Y3, Y4 and Y5). All the timepoint Measures last 1 to 2 weeks.

• 10 Meters Walk Test (10MWT)

  Pre-implantation: Baseline (B) Post-implantation (counting from first surgery) :6-Months measures (M6), 1-Year Measures (Y1), then Yearly Measures until 5 years (Y2, Y3, Y4 and Y5). All the timepoint Measures last 1 to 2 weeks.

• 6 Minute Walk Test (6MWT):

  Pre-implantation: Baseline (B) Post-implantation (counting from first surgery) :6-Months measures (M6), 1-Year Measures (Y1), then Yearly Measures until 5 years (Y2, Y3, Y4 and Y5). All the timepoint Measures last 1 to 2 weeks.

• Timed Up and Go (TUG):

  Pre-implantation: Baseline (B) Post-implantation (counting from first surgery) :6-Months measures (M6), 1-Year Measures (Y1), then Yearly Measures until 5 years (Y2, Y3, Y4 and Y5). All the timepoint Measures last 1 to 2 weeks.

• EMG-based Gait Analysis

  Baseline, 6-Months measures, 1-Year Measures, then Yearly Measures until 5 years.

Other Outcomes (5)

• Stroke-Specific Quality of Life (SS-QOL)

  Baseline; monthly for up to 1 year during the Main Study phase; and every 3 months for up to 5 years during the Optional Study Extension phase

• Psychosocial Impact of Assistive Device Scale (PIADS)

  Monthly for up to 1 year during the Main Study phase; and every 3 months for up to 5 years during the Optional Study Extension phase

• Stroke Impact Scale (SIS)

  Baseline; monthly for up to 1 year during the Main Study phase; and every 3 months for up to 5 years during the Optional Study Extension phase

Study Arms (1)

All participants

EXPERIMENTAL

All participants receive the same intervention.

Device: ARC-BSI Stroke system

Interventions

ARC-BSI Stroke system DEVICE

Implantation of a 64 channel - ECoG array over the sensory motor cortex of one side's upper and lower limbs, combined with an implantation of two 16 channel spinal cord stimulation system, one over the cervical region and one 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 - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be between 18-70 years old at the time of enrolment.
• Must have suffered from a subcortical including brain stem stroke that occurred at least 9 months but not more than 10 years prior to enrolment.
• Must have a score lower than 25 on the Fugl-Meyer upper-limb scale.
• Must be able to stand with or without assistive device for 30 seconds.
• Must have a score higher than 22 at the Montreal Cognitive Assessment.
• Must present right or left hemiplegia.
• Must have completed primary standard of care rehabilitation.
• Must provide and sign the study's Informed Consent prior to any study-related procedures.
• 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 effective contraception for women of childbearing capacity.
• Must be able to withhold antiplatelet/anticoagulation agents perioperatively for the time of the surgeries (if applicable).

You may not qualify if:

• Must not be pregnant or breast feeding (if applicable).
• Must not have the intention to become pregnant during the study (if applicable).
• Must not have any diseases and conditions that would increase the morbidity and mortality of the implantation surgery.
• Must not have any mental instability, including a diagnosis of personality disorder, psychosis, substance abuse, or severe depression as assessed by the psychologist.
• Must not have any other medical conditions that would make the subject unable to participate in testing in the judgment of the investigators (e.g., major cognitive disorder, renal failure, hepatic dysfunction, epilepsy, etc.).
• Must not have ongoing significant dysphagia or aspiration difficulties or require ventilator support.
• Must not have any active implanted device, such as a pacemaker or other neurostimulator.
• Must not have any spinal anatomical abnormalities or incompatibilities with the implanted system precluding surgery.
• Must not have severe spasticity of the upper limb or lower limb (Modified Ashworth Scale \> 3).
• Must not have indication requiring frequent MRIs.
• Must not participate in another clinical study using drugs or medical devices that might interfere with the outcomes of the study.
• Must not be the investigator him/herself, his/her family members, employees, and other dependent persons.

Sponsors & Collaborators

• Ecole Polytechnique Fédérale de Lausanne: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1005, Switzerland

RECRUITING

Related Publications (14)

• Ajiboye AB, Willett FR, Young DR, Memberg WD, Murphy BA, Miller JP, Walter BL, Sweet JA, Hoyen HA, Keith MW, Peckham PH, Simeral JD, Donoghue JP, Hochberg LR, Kirsch RF. Restoration of reaching and grasping movements through brain-controlled muscle stimulation in a person with tetraplegia: a proof-of-concept demonstration. Lancet. 2017 May 6;389(10081):1821-1830. doi: 10.1016/S0140-6736(17)30601-3. Epub 2017 Mar 28.

  PMID: 28363483 BACKGROUND

• Hochberg LR, Bacher D, Jarosiewicz B, Masse NY, Simeral JD, Vogel J, Haddadin S, Liu J, Cash SS, van der Smagt P, Donoghue JP. Reach and grasp by people with tetraplegia using a neurally controlled robotic arm. Nature. 2012 May 16;485(7398):372-5. doi: 10.1038/nature11076.

  PMID: 22596161 BACKGROUND

• Jovanovic LI, Kapadia N, Zivanovic V, Rademeyer HJ, Alavinia M, McGillivray C, Kalsi-Ryan S, Popovic MR, Marquez-Chin C. Brain-computer interface-triggered functional electrical stimulation therapy for rehabilitation of reaching and grasping after spinal cord injury: a feasibility study. Spinal Cord Ser Cases. 2021 Mar 19;7(1):24. doi: 10.1038/s41394-020-00380-4.

  PMID: 33741900 BACKGROUND

• Schirmer CM, Shils JL, Arle JE, Cosgrove GR, Dempsey PK, Tarlov E, Kim S, Martin CJ, Feltz C, Moul M, Magge S. Heuristic map of myotomal innervation in humans using direct intraoperative nerve root stimulation. J Neurosurg Spine. 2011 Jul;15(1):64-70. doi: 10.3171/2011.2.SPINE1068. Epub 2011 Apr 8.

  PMID: 21476796 BACKGROUND

• Uchiyama S, Ishizuka N, Shimada K, Teramoto T, Yamazaki T, Oikawa S, Sugawara M, Ando K, Murata M, Yokoyama K, Minematsu K, Matsumoto M, Ikeda Y; JPPP Study Group. Aspirin for Stroke Prevention in Elderly Patients With Vascular Risk Factors: Japanese Primary Prevention Project. Stroke. 2016 Jun;47(6):1605-11. doi: 10.1161/STROKEAHA.115.012461. Epub 2016 May 10.

  PMID: 27165949 BACKGROUND

• Puentes S, Kaido T, Hanakawa T, Ichinohe N, Otsuki T, Seki K. Internal capsule stroke in the common marmoset. Neuroscience. 2015 Jan 22;284:400-411. doi: 10.1016/j.neuroscience.2014.10.015. Epub 2014 Oct 20.

  PMID: 25453768 BACKGROUND

• Kato K, Sawada M, Nishimura Y. Bypassing stroke-damaged neural pathways via a neural interface induces targeted cortical adaptation. Nat Commun. 2019 Oct 16;10(1):4699. doi: 10.1038/s41467-019-12647-y.

  PMID: 31619680 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

• Selfslagh A, Shokur S, Campos DSF, Donati ARC, Almeida S, Yamauti SY, Coelho DB, Bouri M, Nicolelis MAL. Non-invasive, Brain-controlled Functional Electrical Stimulation for Locomotion Rehabilitation in Individuals with Paraplegia. Sci Rep. 2019 May 1;9(1):6782. doi: 10.1038/s41598-019-43041-9.

  PMID: 31043637 BACKGROUND

• Biasiucci A, Leeb R, Iturrate I, Perdikis S, Al-Khodairy A, Corbet T, Schnider A, Schmidlin T, Zhang H, Bassolino M, Viceic D, Vuadens P, Guggisberg AG, Millan JDR. Brain-actuated functional electrical stimulation elicits lasting arm motor recovery after stroke. Nat Commun. 2018 Jun 20;9(1):2421. doi: 10.1038/s41467-018-04673-z.

  PMID: 29925890 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

• Powell MP, Verma N, Sorensen E, Carranza E, Boos A, Fields DP, Roy S, Ensel S, Barra B, Balzer J, Goldsmith J, Friedlander RM, Wittenberg GF, Fisher LE, Krakauer JW, Gerszten PC, Pirondini E, Weber DJ, Capogrosso M. Epidural stimulation of the cervical spinal cord for post-stroke upper-limb paresis. Nat Med. 2023 Mar;29(3):689-699. doi: 10.1038/s41591-022-02202-6. Epub 2023 Feb 20.

  PMID: 36807682 BACKGROUND

• Wist S, Clivaz J, Sattelmayer M. Muscle strengthening for hemiparesis after stroke: A meta-analysis. Ann Phys Rehabil Med. 2016 Apr;59(2):114-24. doi: 10.1016/j.rehab.2016.02.001. Epub 2016 Mar 8.

  PMID: 26969343 BACKGROUND

Related Links

• World Health Organization (2025), Stroke, Cerebrovascular accident, World Health Organization Eastern Mediterranean Region

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; 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: April 15, 2026
• First Posted: May 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2032
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)