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

2026年6月3日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

3

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • スイス
    • Canton of Vaud
      • Lausanne、Canton of Vaud、スイス、1005
        • 募集
        • Centre Hospitalier Universitaire Vaudois (CHUV)
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：参加者全員
すべての参加者は同じ介入を受けます。
デバイス：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Preliminary safety
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Fugl-Meyer Assessment Lower Extremities
時間枠：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)
時間枠：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):
時間枠：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):
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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.

その他の成果指標

結果測定
メジャーの説明
時間枠
Stroke-Specific Quality of Life (SS-QOL)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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).

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Ecole Polytechnique Fédérale de Lausanne

捜査官

  • 主任研究者：Jocelyne Bloch, MD、CHUV

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2028年10月1日

研究の完了 (推定)

2032年10月1日

試験登録日

最初に提出

2026年4月15日

QC基準を満たした最初の提出物

2026年5月22日

最初の投稿 (実際)

2026年5月28日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月8日

QC基準を満たした最後の更新が送信されました

2026年6月3日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • Stroke-BSI

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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