N. Intering1,2, A. Galvez1,3, V. Spagnolo1,3, L. Asboth1,2, E. Baaklini1,2, H. Lorach1,3, J. Bloch1,2,3, G. Courtine1,3
1.NeuroRestore - Defitech Center for Interventional Neurotherapies, Lausanne, Switzerland, 2CHUV - University Hospital Vaud, Clinical Neurosciences, Lausanne, Switzerland, 3EPFL - Swiss Federal Institute of Technology, Center for Neuroprosthetics and Brain Mind Institute, Lausanne, Switzerland
Background: Spinal cord injuries (SCI) interrupt communication between brain and spinal cord, having devastating impacts on motor control and sensory function leading to paralysis and decrease in quality of life.
Spatiotemporal Epidural Electrical Stimulation (EES) was used in various clinical trials (e.g. Wagner et al., 2018) to activate the lumbosacral region of the spinal cord. We implanted a lead of 16 electrodes, targeting the dorsal roots of lumbosacral segments and a pulse generator to reactivate the spinal cord below injury. Using external triggers, EES delivers bursts of electrical stimulation coinciding with the intended leg movement and amplifying residual brain commands.
A Brain-Spine Interface (BSI) is a digital bridge that re-establishes communication between the brain and the lumbosacral region of the spinal cord, resulting in natural control of leg movements.
Spatiotemporal Epidural Electrical Stimulation (EES) was used in various clinical trials (e.g. Wagner et al., 2018) to activate the lumbosacral region of the spinal cord. We implanted a lead of 16 electrodes, targeting the dorsal roots of lumbosacral segments and a pulse generator to reactivate the spinal cord below injury. Using external triggers, EES delivers bursts of electrical stimulation coinciding with the intended leg movement and amplifying residual brain commands.
A Brain-Spine Interface (BSI) is a digital bridge that re-establishes communication between the brain and the lumbosacral region of the spinal cord, resulting in natural control of leg movements.
Purpose: We proposed a new therapeutic solution for patients with SCI to restore voluntary motor function and present results of the first-in-human fully implantable BSI system, which establishes a direct link between cortical signals and EES.
Methods: In the context of the STIMO-BSI clinical trial (clinicaltrials.gov, NCT04632290), we enrolled a 38-year-old male with a chronic incomplete SCI (C5/C6). He previously participated in the clinical trial STIMO (clinicaltrials.gov, NCT02936453), which involved 5 months of neurorehabilitation, supported by targeted EES. This allowed him to regain the ability to walk using assistive devices. Despite continued use of stimulation at home for three years; he reached a neurological recovery plateau motivating him to enroll in STIMO-BSI.
The participant was implanted with the BSI system composed of:
1. A pair of 64 electrocorticographic electrodes that enable wireless brain recordings over the sensorimotor cortex and
2. A stimulation system, which translates brain signals into stimulation commands, delivered by the EES system, implanted as part of the STIMO trial.
We used the BSI system in 40 sessions of neurorehabilitation (four sessions/week for three hours), including gait training, strengthening of lower extremities, balance training, all with BSI. Before implantation and after the rehabilitation phase, we measured the functional recovery using various clinical assessments.
The participant was implanted with the BSI system composed of:
1. A pair of 64 electrocorticographic electrodes that enable wireless brain recordings over the sensorimotor cortex and
2. A stimulation system, which translates brain signals into stimulation commands, delivered by the EES system, implanted as part of the STIMO trial.
We used the BSI system in 40 sessions of neurorehabilitation (four sessions/week for three hours), including gait training, strengthening of lower extremities, balance training, all with BSI. Before implantation and after the rehabilitation phase, we measured the functional recovery using various clinical assessments.
Results: The BSI system allowed the participant to have full control of the stimulation meaning starting, stopping and adapting walking voluntarily without an external trigger. He improved 42% in the Timed “Up and Go”, and 68% in the Berg Balance Scale after the rehabilitation phase. Walking endurance and speed increased (6-Minute Walking Test improved by 48%) as well as his WISCI II score improved from 13 to 16. A blinded observational gait analysis showed improvement of gait quality assessed by physiotherapists foreign to the study.
Conclusions: The BSI system can act as a neuroprosthetic to restore communication between brain and spinal cord. This digital bridge, converting thoughts into actions, establishes a framework to restore volitional control of movement. A BSI in combination with intensive physiotherapy enabled an individual with chronic incomplete tetraplegia to improve gait quality and support the activities of daily life.
Implications: We introduce BSI as an addition to standard neurorehabilitation to promote neurological recovery and its potential in a bigger scope of patients with incomplete and complete SCI.
Funding acknowledgements:
Defitech foundation, Rolex Award, IRP, Leenards foundation, ONWARD Medical, Pictet Group, SNSF, NCCR, Sinergia, SNF, InnoSuisse, ERC and more
Keywords:
Research
Epidural Electrical Stimulation
Neuromodulation
Research
Epidural Electrical Stimulation
Neuromodulation
Topics:
Neurology: spinal cord injury
Innovative technology: robotics
Disability & rehabilitation
Neurology: spinal cord injury
Innovative technology: robotics
Disability & rehabilitation
Did this work require ethics approval? Yes
Institution: Swissethics
Committee: CER-VD
Ethics number: CER-VD2020-01814
All authors, affiliations and abstracts have been published as submitted.
