Interfacing With NeuroTechnology to Expand Neural Throughput (INTENT)

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07521930
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • INTENT Neural Interface System — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: INTENT Neural Interface System
    INTENT Neural Interface System

Primary Outcome Measure

Incidence of Device-Related Adverse Events [Safety and Tolerability] [ Time Frame: 54 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins MedicineBaltimoreMaryland21205
Nathan E Crone, MD
[email protected]
410-955-6772

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By research site
Johns Hopkins Medicine· Baltimore, MD

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