Back to search results

INTENT Neural Interface System for Paralysis

This study is testing the safety and initial effectiveness of a device called the INTENT Neural Interface System. This system involves implanting up to eight tiny electrode arrays into areas of the brain that control movement and sensation. The goal is to help adults with severe paralysis, such as from spinal cord injury, ALS (Amyotrophic Lateral Sclerosis), or stroke, control assistive devices. The main way success will be measured is by looking at any device-related side effects over 54 weeks. The study is currently unclear on its recruitment status and plans to enroll 5 participants who are between 18 and 80 years old and have complete or incomplete tetraplegia (paralysis affecting all four limbs), tetraparesis (weakness affecting all four limbs), severe ataxia (lack of muscle control), or other disabling motor impairments in both upper limbs.

Study design
This is an interventional study with an unclear phase, planning to enroll 5 participants. It is designed to evaluate the safety and preliminary effectiveness of the INTENT Neural Interface System.
What's involved
You would have up to eight microelectrode arrays implanted in your brain, connected to up to three pedestals on your skin. Neural recording and stimulation will occur during study visits, at least weekly and up to five days per week throughout the study.
Compensation
Not stated in the trial record.
Follow-up
Safety and tolerability will be measured at 54 weeks after the device is implanted.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07521930

Interfacing With NeuroTechnology to Expand Neural Throughput (INTENT)

Recruiting
NAAges 18–80InterventionalDevice feasibility
Johns Hopkins University
~5 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:INTENT Neural Interface System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Device-Related Adverse Events [Safety and Tolerability]
Measured over 54 weeks

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

Explore related trials

Amyotrophic Lateral SclerosisBrain stem infarctionMuscular DystrophyQuadriplegiaSpinal Cord InjuryTetraparesis

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Nathan Crone, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Nathan E Crone, MD
[email protected]
4109559441
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of Device-Related Adverse Events [Safety and Tolerability]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.