Hemiplegia, Stroke
Conditions
Keywords
Spinal cord stimulation, Brain computer interface, Brain spine interface
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.
Detailed description
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.
Interventions
DEVICEARC-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.
Sponsors
Ecole Polytechnique Fédérale de Lausanne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
monocentric, single-arm, non-blinded, non-randomized, interventional
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preliminary safety | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | Clinical measure to assess walking speed (in m/s) over 10 meters. |
| 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. | Submaximal test to assess endurance during 6 minutes of walking. |
| 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. | Timed test of functional mobility (stand-up, walk, turn around, sit-down) |
| EMG-based Gait Analysis | 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. |
| Kinematics-based Gait Analysis | 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. |
| Fugl-Meyer Assessment Upper Extremities (FMA-UE) | 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 |
| Action Research Arm Test (ARAT) | 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). |
| Box and Block Test (BBT) | 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 |
| Range of Motion | 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. |
| Modified Ashworth Scale (MAS) | 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). |
| Chedoke-McMaster Stroke Assessment (CMSA) | 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. |
| Muscle Strength Testing (MST) | 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. |
| Somatosensory Evoked Potential (SSEP) | 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. |
Countries
Switzerland
Contacts
CONTACTJocelyne Bloch, MD
CONTACTHenri Lorach, PhD
PRINCIPAL_INVESTIGATORJocelyne Bloch, MD
CHUV
Outcome results
None listed