NCT07521930

Interfacing With NeuroTechnology to Expand Neural Throughput (INTENT)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Tetraplegia/Tetraparesis
• Amyotrophic Lateral Sclerosis (ALS)
• Muscular Disorders, Atrophic
• Brain Stem Stroke
• Spinal Cord Injuries (SCI)
• Muscular Dystrophies
• Muscular Atrophy, Progressive
• Pontine Hemorrhage
• Pontine Infarction

Interventions

Type	Name	Description
DEVICE	INTENT 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.

Timeline

• Start date: 2026-06-01
• Primary completion: 2028-06-01
• Completion: 2028-12-01
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study