Interfacing With NeuroTechnology to Expand Neural Throughput (INTENT)
Johns Hopkins University
Summary
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.
Description
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).
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 irr…
Interventions
- DeviceINTENT Neural Interface System
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.
Location
- Johns Hopkins MedicineBaltimore, Maryland