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.
The goal of this early feasibility study is to evaluate the safety and preliminary efficacy of chronic recording and stimulation of the human sensory, motor, and integrative cortices with intracortical microelectrodes to control assistive devices (virtual or real) while also receiving environmental and/or haptic feedback (virtual or real sensors).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
5
Up 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.
Johns Hopkins Medicine
Baltimore, Maryland, United States
RECRUITINGIncidence 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.
Time frame: 54 weeks
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.
Time frame: 54 weeks
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.
Time frame: 54 weeks
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.
Time frame: 54 weeks
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