Study of the INTENT Neural Interface System to Help Adults with Severe Paralysis Control Assistive Devices Early Feasibility Trial Using Brain Implants for Recording and Stimulation

What this Trial Is About

Researchers are evaluating the safety and preliminary effectiveness of an implantable device designed to record and stimulate different areas of the brain in adults with disabling paralysis. This early feasibility study focuses on using intracortical microelectrodes placed in sensory, motor, and integrative brain regions to help participants control assistive devices and receive environmental or touch feedback. The study targets adults with conditions such as tetraplegia, ALS, brain stem stroke, and other severe motor impairments affecting upper limb function and communication. Participants will have up to eight microelectrode arrays implanted in specific brain areas connected to percutaneous pedestals. Neural recording and stimulation sessions will occur during study visits, which can happen at least weekly and up to five days per week throughout the study period. The device system, called the INTENT Neural Interface System, is being studied for its feasibility in enabling brain-computer interface control of virtual or real assistive devices while providing sensory feedback. Throughout the trial, participants will attend regular visits for neural recording, stimulation, and device monitoring over approximately 54 weeks. Researchers will assess device-related adverse events, the number of participants who can control assistive devices using the brain interface, those who perceive sensory feedback, and the functionality of the implanted microelectrodes. Participants must be able to communicate reliably and have stable psychosocial support. Safety, tolerability, and device performance will be closely monitored during the study.

Interfacing With NeuroTechnology to Expand Neural Throughput (INTENT)