Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation (Stroke-BSI)
3. juni 2026 oppdatert av: 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.
Studieoversikt
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
3
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jocelyne Bloch, MD
- Telefonnummer: +41 79 556 29 51
- E-post: jocelyne.bloch@chuv.ch
Studer Kontakt Backup
- Navn: Henri Lorach, PhD
- Telefonnummer: +41 77 495 50 48
- E-post: henri.lorach@epfl.ch
Studiesteder
-
-
Canton of Vaud
-
Lausanne, Canton of Vaud, Sveits, 1005
- Rekruttering
- Centre Hospitalier Universitaire Vaudois (CHUV)
-
Ta kontakt med:
- Jocelyne Bloch
- Telefonnummer: +41 79 556 2951
- E-post: jocelyne.bloch@chuv.ch
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Alle deltakere
Alle deltakere får samme intervensjon.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Preliminary safety
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Fugl-Meyer Assessment Lower Extremities
Tidsramme: 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)
Tidsramme: 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):
Tidsramme: 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):
Tidsramme: 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
Tidsramme: 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:
|
Baseline, 6-Months measures, 1-Year Measures, then Yearly Measures until 5 years.
|
|
Kinematics-based Gait Analysis
Tidsramme: 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:
|
Baseline, 6-Months measures, 1-Year Measures, then Yearly Measures until 5 years.
|
|
Fugl-Meyer Assessment Upper Extremities (FMA-UE)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Stroke-Specific Quality of Life (SS-QOL)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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).
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Jocelyne Bloch, MD, CHUV
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. oktober 2028
Studiet fullført (Antatt)
1. oktober 2032
Datoer for studieregistrering
Først innsendt
15. april 2026
Først innsendt som oppfylte QC-kriteriene
22. mai 2026
Først lagt ut (Faktiske)
28. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Stroke-BSI
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .