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Interfacing With NeuroTechnology to Expand Neural Throughput (INTENT)

NCT07521930 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2026-07-08

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Blackrock Neurotech

    collaborator UNKNOWN

  • JHU Applied Physics Laboratory

    collaborator UNKNOWN

  • Kennedy Krieger Institute, Baltimore, MD

    collaborator UNKNOWN

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Nathan Crone, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-06-30
Completion
2028-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07521930 on ClinicalTrials.gov