Interfacing With NeuroTechnology to Expand Neural Throughput (INTENT) (INTENT)

April 2, 2026 updated by: Johns Hopkins University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Johns Hopkins Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 irreversible neuromuscular disease, including muscular dystrophy and motor neuron disease, including amyotrophic lateral sclerosis (ALS). *Brain stem stroke is defined as an acute onset of neurological deficit with clinical features of brain stem or cerebellar dysfunction lasting more than 24 hours together with computed tomography (CT) or magnetic resonance imaging (MRI) evidence of ischemic infarction or parenchymal hemorrhage.
  • Candidates with traumatic spinal cord injury must have a complete or incomplete tetraplegia or tetraparesis (ASIA Impairment Scale A, B, C) with an injury level of C6 or higher.
  • Candidates with tetraplegia or tetraparesis from traumatic SCI and other non-progressive neurological disorders must have an upper extremity motor score (UEMS, ISNCSCI) of 7 or less in each of the upper extremities. Candidate must also have less than antigravity strength (< 3) throughout the lower limbs.
  • Candidates with progressive conditions with shortened life expectancy, such as ALS, must have less than antigravity strength (<3) throughout the upper limbs.
  • Persistence of motor impairments at least 12 months prior to enrollment if due to a non-progressive neurological cause such as stroke or spinal cord injury
  • Meeting surgical safety criteria, including surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary consultants
  • Ability to communicate reliably, such as through speech or eye movement
  • Stable psychosocial support system with caregiver capable of monitoring participant throughout the study
  • Ability and willingness to travel to study location up to five days per week for the duration of the study
  • Ability to understand and comply with study session instructions
  • Corrected visual acuity sufficient for use of computer monitor

Exclusion Criteria:

  • Psychiatric conditions or cognitive impairments that would interfere with obtaining informed consent or fully participating in study activities.
  • Individuals with active implanted devices, including devices that are incompatible with magnetic resonance imaging (MRI).
  • Contraindications to MRI or anticipated need for an MRI during the study period
  • Medical conditions contraindicating device implantation surgery (for example significant pulmonary, cardiovascular, metabolic, or renal impairments making the surgical procedure unsafe)
  • Chronic anti-coagulation and medical contraindication to temporary suspension for surgery
  • Medical conditions contraindicating chronic device implantation (e.g. osteomyelitis, chronic infection, poorly controlled diabetes, cancer, severe autoimmune disorder, epilepsy, poor wound healing)
  • Participants with dental caries and a significant risk of dental or periodontal infection
  • Chronic oral or intravenous use of steroids or immunosuppressive therapy
  • Active cancer within the past year or ongoing chemotherapy
  • Uncontrolled autonomic dysreflexia within the past 3 months
  • Hydrocephalus with or without an implanted ventricular shunt
  • Other chronic, unstable medical conditions that could interfere with subject participation.
  • Persistent suicidal ideation within the past 12 months.
  • History of substance use disorder within the past year
  • Pregnancy (confirmation through blood test)
  • Nursing an infant, planning to become pregnant, or not using adequate birth control

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: INTENT Neural Interface System
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.
Other Names:
  • neuroprosthetic
  • brain-computer interface
  • NeuroPort
  • neural prosthesis
  • neural prosthetic
  • brain computer interface

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Device-Related Adverse Events [Safety and Tolerability]
Time Frame: 54 weeks
The primary endpoint of this study is to determine the incidence of device-related adverse events. This will be met if the device is not explanted due to safety concerns throughout the duration of the study.
54 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants achieving BCI control of assistive devices
Time Frame: 54 weeks
A secondary endpoint of this study is the number of participants achieving simultaneous control of two or more assistive devices during the study period.
54 weeks
Number of participants perceiving sensory feedback
Time Frame: 54 weeks
A secondary endpoint is the number of participants who perceive sensory feedback from intracortical microstimulation during BCI control of assistive devices.
54 weeks
Number of microelectrodes capable of neural recording and stimulation
Time Frame: 54 weeks
A secondary endpoint will be the number of implanted microelectrodes that are capable of neural recording and stimulation during the study period.
54 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Kennedy Krieger Institute, Baltimore, MD
Blackrock Neurotech
JHU Applied Physics Laboratory

Investigators

  • Principal Investigator: Nathan Crone, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00516445

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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