Interfacing With NeuroTechnology to Expand Neural Throughput (INTENT)

NCT07521930 | Recruiting DMC FDA Device

• 1 other identifier: IRB00516445
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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; Muscular Atrophy, Progressive; Tetraplegia/Tetraparesis; Amyotrophic Lateral Sclerosis (ALS); Muscular Disorders, Atrophic; Spinal Cord Injuries (SCI); Muscular Dystrophies; Pontine Hemorrhage; Pontine Infarction

Keywords

Assistive device; Brain Computer Interface

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (3)

• Number of participants achieving BCI control of assistive devices

  54 weeks

• Number of participants perceiving sensory feedback

  54 weeks

• Number of microelectrodes capable of neural recording and stimulation

  54 weeks

Study Arms (1)

INTENT Neural Interface System

EXPERIMENTAL

INTENT Neural Interface System

Device: INTENT Neural Interface System

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.

Also known as: NeuroPort, brain-computer interface, brain computer interface, neural prosthesis, neural prosthetic, neuroprosthetic

INTENT Neural Interface System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead
• Blackrock Neurotech: collaborator
• JHU Applied Physics Laboratory: collaborator
• Kennedy Krieger Institute, Baltimore, MD: collaborator

Study Sites (1)

Johns Hopkins Medicine

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Conditions

Quadriplegia; Amyotrophic Lateral Sclerosis; Muscular Disorders, Atrophic; Brain Stem Infarctions; Spinal Cord Injuries; Muscular Dystrophies; Muscular Atrophy, Spinal

Interventions

Brain-Computer Interfaces; Neural Prostheses

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Diseases; Musculoskeletal Diseases; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis; Trauma, Nervous System; Wounds and Injuries; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Prostheses and Implants

Study Officials

• Nathan Crone, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathan E Crone, MD

CONTACT

4109559441; ncrone@jhmi.edu

Francesco Tenore, PhD

CONTACT

4437789774; francesco.tenore@jhuapl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 13, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)