The goal of this clinical trial is to evaluate the safety and preliminary efficacy of an implantable device that records and stimulates different areas of the brain to allow adults affected by disabling paralysis (see Eligibility for more details) to control and receive feedback from assistive devices.
Complete or incomplete tetraplegia (quadriplegia), tetraparesis (quadriparesis), severe ataxia, or disabling motor impairments in both upper limbs, based on neurological exam. In addition, these motor impairments may be combined with severe motor-related speech impairment (dysarthria or anarthria), as in Locked In Syndrome (LIS) and amyotrophic lateral sclerosis (ALS), including the bulbar variant of ALS.
Clinical diagnosis must be established for the etiology of motor impairments, including brainstem stroke*, traumatic spinal cord injury (SCI), or progressive and irreversible neuromuscular disease, including muscular dystrophy and motor neuron disease, including amyotrophic lateral sclerosis (ALS). *Brain stem stroke is defined as an acute onset of neurological deficit with clinical features of brain stem or cerebellar dysfunction lasting more than 24 hours together with computed tomography (CT) or magnetic resonance imaging (MRI) evidence of ischemic infarction or parenchymal hemorrhage.
Candidates with traumatic spinal cord injury must have a complete or incomplete tetraplegia or tetraparesis (ASIA Impairment Scale A, B, C) with an injury level of C6 or higher.
Candidates with tetraplegia or tetraparesis from traumatic SCI and other non-progressive neurological disorders must have an upper extremity motor score (UEMS, ISNCSCI) of 7 or less in each of the upper extremities. Candidate must also have less than antigravity strength (< 3) throughout the lower limbs.
Psychiatric conditions or cognitive impairments that would interfere with obtaining informed consent or fully participating in study activities.
Individuals with active implanted devices, including devices that are incompatible with magnetic resonance imaging (MRI).
Contraindications to MRI or anticipated need for an MRI during the study period
Medical conditions contraindicating device implantation surgery (for example significant pulmonary, cardiovascular, metabolic, or renal impairments making the surgical procedure unsafe)
Single group
INTENT Neural Interface System
DeviceUp to eight microelectrode arrays will be implanted on motor, sensory, and integrative cortex, connected to up to three percutaneous pedestals. Neural recording and stimulation will occur during study visits that will occur at least weekly and up to five days per week throughout the study.
Incidence of Device-Related Adverse Events [Safety and Tolerability]
The primary endpoint of this study is to determine the incidence of device-related adverse events. This will be met if the device is not explanted due to safety concerns throughout the duration of the study.
Number of participants achieving BCI control of assistive devices
A secondary endpoint of this study is the number of participants achieving simultaneous control of two or more assistive devices during the study period.
Number of participants perceiving sensory feedback
A secondary endpoint is the number of participants who perceive sensory feedback from intracortical microstimulation during BCI control of assistive devices.
Number of microelectrodes capable of neural recording and stimulation
A secondary endpoint will be the number of implanted microelectrodes that are capable of neural recording and stimulation during the study period.
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Johns Hopkins University
Lead sponsor
Blackrock Neurotech
Collaborator
JHU Applied Physics Laboratory
Collaborator
Kennedy Krieger Institute, Baltimore, MD
Collaborator
