Recruiting

Implantable DeviceInterfacing With NeuroTechnology to Expand Neural Throughput (INTENT)

Sponsor:

Johns Hopkins University

Code:

NCT07521930

Conditions

Tetraplegia/Tetraparesis

Amyotrophic Lateral Sclerosis (ALS)

Muscular Disorders, Atrophic

Brain Stem Stroke

Spinal Cord Injuries (SCI)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

INTENT Neural Interface System

Study Details

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

Tetraplegia/Tetraparesis

Amyotrophic Lateral Sclerosis (ALS)

Muscular Disorders, Atrophic

Brain Stem Stroke

Spinal Cord Injuries (SCI)

Study ID

NCT07521930

Start date

Sep, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: INTENT Neural Interface System

INTENT Neural Interface System

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Nathan E Crone, MD

4109559441 ncrone@jhmi.edu

Francesco Tenore, PhD

4437789774 francesco.tenore@jhuapl.edu

Locations

Johns Hopkins Medicine

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Nathan E Crone, MD

410-955-6772 ncrone@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Sep 2, 2026

Last verified

Sep, 2026

Keywords

Assistive device
Brain Computer Interface

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-09-02.