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

3 juni 2026 bijgewerkt door: Jocelyne Bloch, Ecole Polytechnique Fédérale de Lausanne

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

In a current first-in-human clinical trial, called STIMO (ClinicalTrials.gov, NCT02936453), Electrical Epidural 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, EES immediately enhances walking function and, with repeated use as part of the EES-assisted neurorehabilitation program, improves leg motor control and neurological recovery in severe SCI participants to a certain extent. Linking brain activity to spinal stimulation, as shown in preclinical and clinical studies, enhances usability of EES and neurological recovery.

Clinatec (CEA, Grenoble, France) has developed an implantable electrocorticogram (ECoG) recording device with a 64-channel epidural electrode array called WIMAGINE capable of recording electrical signals from the motor cortex for an extended period and with a high signal to noise ratio. This ECoG-based system allowed tetraplegic patients to control an exoskeleton (Clinicaltrials.gov, NCT 02550522) with up to 8 degrees of freedom for the upper limb control. This device has been implanted in 5 chronic participants so far; one of them has been using this system both at the hospital and at home for more than 3 years.

The WIMAGINE ECoG technology has been integrated with epidural electrical stimulation (EES) across multiple clinical trials exploring implantable brain-spine interfaces. In the STIMO-BSI trial (NCT04632290), real-time decoding of cortical motor intentions for leg movements was used to modulate lumbar EES, enabling a chronic SCI participant to regain volitional control of standing and walking, with neurological improvements persisting even without the system after three years. In the UP2 trial (NCT05665998), two participants with incomplete C3/C4 SCI received cervical EES arrays and a WIMAGINE implant to decode up to six upper-limb motor states; brain-controlled cervical EES was shown to be safe, feasible, and supportive of neurological recovery of arm and hand function. In the Think2Go trial (NCT06243952), two participants with complete motor paraplegia received a WIMAGINE implant paired with the ARC-IM lumbar EES system, enabling lower-limb movement within days and leading to restored voluntary leg control and unsupported walking after months of rehabilitation. Together, these studies demonstrate that implantable ECoG-based brain-spine interfaces can safely decode motor intentions and drive targeted EES to restore multi-limb motor functions and promote neurological recovery across a range of SCI severities.

In this study, the investigators will assess the preliminary safety and effectiveness of ECoG-controlled EES in individuals with chronic stroke who suffer from hemiplegia, to establish a direct bridge between the motor intention and the spinal cord. This could improve or restore voluntary control of arm and leg movement as well as promote neurological recovery when combined with neurorehabilitation. The WIMAGINE ECoG system will be coupled with the ARC-IM purpose-built spinal cord stimulation technology in the ARC-BSI Stroke system, which is equivalent technology to systems currently used in the UP2 (ARC-BSI Cervical system) and Think2Go (ARC-BSI Lumbar system) clinical studies.

Studietype

Ingrijpend

Inschrijving (Geschat)

3

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Zwitserland
    • Canton of Vaud
      • Lausanne, Canton of Vaud, Zwitserland, 1005
        • Werving
        • Centre Hospitalier Universitaire Vaudois (CHUV)
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Alle deelnemers
Alle deelnemers krijgen dezelfde interventie.
Apparaat: ARC-BSI Stroke system
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Preliminary safety
Tijdsspanne: From enrollment until End of the Study timepoint (at 5 years)
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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Fugl-Meyer Assessment Lower Extremities
Tijdsspanne: 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.
A performance-based measure used to assess motor functioning, balance, sensation, joint range of motion and joint pain in upper and lower limbs of stroke patients.
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)
Tijdsspanne: 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.
Clinical measure to assess walking speed (in m/s) over 10 meters.
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):
Tijdsspanne: 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.
Submaximal test to assess endurance during 6 minutes of walking.
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):
Tijdsspanne: 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 test of functional mobility (stand-up, walk, turn around, sit-down)
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
Tijdsspanne: Baseline, 6-Months measures, 1-Year Measures, then Yearly Measures until 5 years.

Evaluation of locomotion parameters during different tasks, assessing biomechanics of movement through the acquisition of electromyographic data (electrical activity, in millivolts, associated to muscular fibers contraction) with placement of wearable sensors on the legs muscles.

The tasks performed will be the following:

  • Walking overground.
  • Parkours: the participant will be asked to perform tasks such as: change the walking speed, walk with head turns, stepping over and turn around obstacles, walk on a soft surface and climb stairs, walk with cognitive load (e.g., counting backward by threes). For this task, a parkours with obstacles, different surfaces, and a staircase will be prepared.
  • Balance: the participant will be asked to perform a series of balance exercises - such as heel and toe raises, side stepping, single-leg standing, weight shifting, and sit-to-stand movements - to assess balance and symmetry.
Baseline, 6-Months measures, 1-Year Measures, then Yearly Measures until 5 years.
Kinematics-based Gait Analysis
Tijdsspanne: Baseline, 6-Months measures, 1-Year Measures, then Yearly Measures until 5 years.

Evaluation of locomotion parameters during different tasks, assessing biomechanics of movement through the acquisition of kinematic data (displacement in the 3 directions of space) with placement of wearable markers on the legs joints; only the 3D displacement of these markers placed on each joint is assessed, and all measurements are expressed in millimeters across the following tasks:

  • Walking overground.
  • Parkours: the participant will be asked to perform tasks such as: change the walking speed, walk with head turns, stepping over and turn around obstacles, walk on a soft surface and climb stairs, walk with cognitive load (e.g., counting backward by threes). For this task, a parkours with obstacles, different surfaces, and a staircase will be prepared.
  • Balance: the participant will be asked to perform a series of balance exercises - such as heel and toe raises, side stepping, single-leg standing, weight shifting, and sit-to-stand movements - to assess balance and symmetry.
Baseline, 6-Months measures, 1-Year Measures, then Yearly Measures until 5 years.
Fugl-Meyer Assessment Upper Extremities (FMA-UE)
Tijdsspanne: 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.
A performance-based measure used to assess motor functioning, balance, sensation, joint range of motion and joint pain in upper and lower limbs of stroke patients
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.
Action Research Arm Test (ARAT)
Tijdsspanne: 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.
An observational measure to assess the upper extremity performance (coordination, dexterity, and functioning) through four subscales (grasp, grip, pinch, and gross movement).
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.
Box and Block Test (BBT)
Tijdsspanne: 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.
Test composed of a wooden box divided into two compartments by a partition and 150 blocks. The participant has to move the maximum number of blocks within 60 seconds. It measures unilateral gross manual dexterity
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.
Range of Motion
Tijdsspanne: 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.
It will be evaluated for the following movements for both unaffected and affected limbs: shoulder abduction, shoulder rotations, shoulder flexion, elbow flexion, elbow extension hand dorsiflexion and palmarflexion. The aim of this test is to assess the degree of joint mobility and functional limitations in the affected upper limb.
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.
Modified Ashworth Scale (MAS)
Tijdsspanne: 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.
The participant's upper and lower limb spasticity levels are assessed by rating the resistance of a muscle to a passive range of motion about a single joint (6-points nominal scale).
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.
Chedoke-McMaster Stroke Assessment (CMSA)
Tijdsspanne: 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.
An assessment tool utilized to measure physical impairment and activity of the participant in 6 domains (shoulder pain and stages of recovery of postural control, arm, hand, leg and foot), and an activity inventory, which assesses gross motor function (rolling, sitting, transferring, and standing) and walking.
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.
Muscle Strength Testing (MST)
Tijdsspanne: 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.
It will be assessed during different single joint movements of the upper and lower limbs. The aim of this test is to evaluate the residual voluntary muscle force and identify specific weaknesses that may impact functional movement.
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.
Somatosensory Evoked Potential (SSEP)
Tijdsspanne: 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.
An electrophysiological measure to evaluate the transmission of electrical activity resulting from touch stimulation.
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.

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Stroke-Specific Quality of Life (SS-QOL)
Tijdsspanne: 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
The SS-QOL assesses health-related quality of life specific to stroke survivors. It considers different areas including behavior, cognition, functional mobility, language, negative affect, personality, quality of life, social relationships, and upper extremity function. This questionnaire will help the investigators to evaluate the areas in which the participant is most affected and determine if there is an evolution during the study.
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)
Tijdsspanne: 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
The PIADS is a 26-item, self-report questionnaire designed to assess the effects of an assistive device on functional independence, well-being, and quality of life
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)
Tijdsspanne: 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
A self-report questionnaire that evaluates disability and health-related quality of life after stroke. It assesses different areas including activities of daily living, cognition, communication, depression, function mobility, gait, general health, life participation, quality of life, social relationships, social support, and upper extremity function.
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
Goal Attainment Scaling (GAS)
Tijdsspanne: 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).
A method of scoring the extent to which patient's individual goals are achieved during intervention. In effect, each patient has their own outcome measure, but this is scored in a standardized way to allow statistical analysis.
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).
Patient's Global Impression of Change (PGIC)
Tijdsspanne: 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).
A single-item questionnaire to measure the change in clinical status, disease severity, or disease improvement, and evaluate the response of a condition to the given therapy.
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).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ecole Polytechnique Fédérale de Lausanne

Onderzoekers

  • Hoofdonderzoeker: Jocelyne Bloch, MD, CHUV

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 oktober 2028

Studie voltooiing (Geschat)

1 oktober 2032

Studieregistratiedata

Eerst ingediend

15 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 mei 2026

Eerst geplaatst (Werkelijk)

28 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

3 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Stroke-BSI

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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