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    "path": "/trials/NCT04632290",
    "result": {"pageContext":{"pagePath":"/trials/NCT04632290","trial":{"nct_id":"NCT04632290","brief_title":"Brain-controlled Spinal Cord Stimulation in Patients With Spinal Cord Injury","official_title":"Brain-controlled Spinal Cord Stimulation in Patients With Spinal Cord Injury","about_trial":"This is a clinical trial enrolling individuals with chronic spinal cord injuries to test combining an implanted device to record brain signal activity (intention to move) and spinal cord stimulation. Spinal cord stimulation is a technique for activating nerve networks to increase spinal cord function. Brain signals for intention to move are recorded on an implanted device (electrocorticogram) directly from the surface of the brain. The brain signals are decoded by computer and then sent to stimulation electrodes implanted on the spinal cord; this will enable voluntary muscle activity (such as leg movement), as intended. The goal is to provide direct communication between a person’s intention to move and the spinal cord.\n\nIf included in the trial, participants will undergo a surgery to implant the device to measure brain activity, and another surgery to implant a stimulating device on the spinal cord. Additionally, a neurorehabilitation program will be performed. Testing will assess safety, function, and measures of gait performance over the period of 1 year.","age_from":18,"age_to":65,"ais_a":true,"ais_b":true,"ais_c":true,"ais_d":true,"ais_e":false,"time_since_injury_from":12,"time_since_injury_from_unit":"months","time_since_injury_to":65,"time_since_injury_to_unit":"years","healthy_volunteers":false,"inclusion_criteria":["have completed the main phase of the STIMO (spinal cord stimulation) trial (NCT02936453)","NOT have baclofen pump implanted","NOT have other implanted device, e.g. pacemaker"],"study_type":"interventional","allocation":"N/A","brief_description":"In a current first-in-human study, called Stimulation Movement Overground (STIMO, NCT02936453), Epidural Electrical 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, it was demonstrated that EES results in an immediate enhancement of walking function, and that when applied repeatedly as part of a neurorehabilitation program, EES can improve leg motor control and trigger neurological recovery in individuals with severe SCI to a certain extent (Wagner et al. 2018).\n\nPreclinical studies showed that linking brain activity to the onset and modulation of spinal cord stimulation protocols not only improves the usability of the stimulation, but also augments neurological recovery. Indeed, rats rapidly learned to modulate their cortical activity in order to adjust the amplitude of spinal cord stimulation protocols. This brain-spine interface allowed them to increase the amplitude of the movement of their otherwise paralyzed legs to climb up a staircase (Bonizzato et al. 2018). Moreover, gait rehabilitation enabled by this brain-spine interface (BSI) augmented plasticity and neurological recovery. When EES was correlated with cortical neuron activity during training, rats showed better recovery than when training was only supported by continuous stimulation (Bonizzato et al. 2018). This concept of brain spine-interface was validated in non-human primates (Capogrosso et al. 2016).\n\nClinatec (Grenoble, France) has developed a fully implantable electrocorticogram (ECoG) recording device with a 64-channel epidural electrode array capable of recording electrical signals from the motor cortex for an extended period of time and with a high signal to noise ratio the electrical signals from the motor cortex. This ECoG-based system allowed tetraplegic patients to control an exoskeleton (ClinicalTrials.gov, NCT02550522) with up to 8 degrees of freedom for the upper limb control (Benabid et al. 2019). This device was implanted in 2 individuals so far; one of them has been using this system both at the hospital and at home for more than 3 years.\n\nWe hypothesize that ECoG-controlled EES in individuals with SCI will establish a direct bridge between the patient's motor intention and the spinal cord below the lesion, which will not only improve or restore voluntary control of leg movements, but will also boost neuroplasticity and neurological recovery when combined with neurorehabilitation.","detailed_description":"Participants are implanted with a (recording) device at the surface of the brain.\nParticipants are implanted with a (stimulating) device at the surface of the spinal cord.\nThe participants will undergo training and rehabilitation.\nFinal testing will be performed at around 1 year.\n“Training specifications are not provided. Further information needs to be acquired directly from the investigator.”","final_testing_performed":null,"version_id":5,"emsci_trial":false,"curation_status":"curated","overall_recruitment_status":"active","primary_intervention":{"id":5,"name":"Technology","parent_id":null,"icon_name":"technology"},"primary_benefit":{"id":12,"name":"Standing/walking/mobility","parent_id":null,"icon_name":"walking"},"sex":"All","injury_level_from":"C1","injury_level_to":"T10","start_date":"2021-07-04","organization":"Ecole Polytechnique Fédérale de Lausanne","benefits":[{"id":1,"name":"Arm/hand function","parent_id":null,"icon_name":"hand-expand"},{"id":5,"name":"General health","parent_id":null,"icon_name":"general-health"},{"id":6,"name":"Mental health and psychosocial factors","parent_id":null,"icon_name":"mental-health"},{"id":8,"name":"Sensory function","parent_id":null,"icon_name":"sensory-benefits"},{"id":11,"name":"Spasticity","parent_id":null,"icon_name":"wave"},{"id":12,"name":"Standing/walking/mobility","parent_id":null,"icon_name":"walking"},{"id":90,"name":"Mechanism of action","parent_id":null,"icon_name":null}],"injuries":[{"id":3,"name":"Traumatic","parent_id":1,"pivot":{"trial_id":2833,"injury_id":3}}],"interventions":[{"id":3,"name":"Rehabilitation","parent_id":null,"icon_name":"medical-rehabilitation"},{"id":4,"name":"Surgery","parent_id":null,"icon_name":"scalpel"},{"id":5,"name":"Technology","parent_id":null,"icon_name":"technology"}],"outcome_measures":[],"recovery_mechanisms":[],"published_at":"2021-11-05T20:13:35.000000Z","modified_at":"2021-11-05T20:13:35.000000Z"},"layout":"trial"}},
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