Tetraplegia/TetraparesisINTENTNCT07521930
Interfacing With NeuroTechnology to Expand Neural Throughput (INTENT)
A study testing INTENT Neural Interface System in people with Tetraplegia/Tetraparesis and Amyotrophic Lateral Sclerosis (ALS), run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tetraplegia/Tetraparesis, Amyotrophic Lateral Sclerosis (ALS), Muscular Disorders, Atrophic
- What is being tested?
- INTENT Neural Interface System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Medicine
Baltimore, Maryland, 21205
Nathan E Crone, MD, 410-955-6772, ncrone@jhmi.edu
About this study
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.
Read the 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).
- Conditions
- Tetraplegia/Tetraparesis, Amyotrophic Lateral Sclerosis (ALS), Muscular Disorders, Atrophic, Brain Stem Stroke, Spinal Cord Injuries (SCI), Muscular Dystrophies
- Being tested
- INTENT Neural Interface System
- Keywords
- Assistive device, Brain Computer Interface
- Medical subject headings
- Quadriplegia, Amyotrophic Lateral Sclerosis, Muscular Disorders, Atrophic, Brain Stem Infarctions, Spinal Cord Injuries, Muscular Dystrophies, Muscular Atrophy, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTENT Neural Interface SystemDevice
Also called NeuroPort, brain-computer interface, brain computer interface, neural prosthesis
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.
| Study group | Role | What they receive |
|---|---|---|
| INTENT Neural Interface System | Experimental | INTENT Neural Interface System Receives: Device: INTENT Neural Interface System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 54 weeks
Secondary outcomes (3)
Number of participants achieving BCI control of assistive devices
A secondary endpoint of this study is the number of participants achieving simultaneous control of two or more assistive devices during the study period.
Measured: 54 weeks
Number of participants perceiving sensory feedback
A secondary endpoint is the number of participants who perceive sensory feedback from intracortical microstimulation during BCI control of assistive devices.
Measured: 54 weeks
Number of microelectrodes capable of neural recording and stimulation
A secondary endpoint will be the number of implanted microelectrodes that are capable of neural recording and stimulation during the study period.
Measured: 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study startJan 2027 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tetraplegia/TetraparesisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Blackrock Neurotech, JHU Applied Physics Laboratory, Kennedy Krieger Institute, Baltimore, MD
- Responsible party
- Sponsor
- Investigators
- Nathan Crone, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521930
- Sponsor's protocol ID
- IRB00516445
- Acronym
- INTENT
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interfacing With NeuroTechnology to Expand Neural Throughput (INTENT)
- ClinicalTrials.gov ID
- NCT07521930
- Acronym / sponsor ID
- INTENT / IRB00516445
- Conditions
- Tetraplegia/Tetraparesis, Amyotrophic Lateral Sclerosis (ALS), Muscular Disorders, Atrophic, Brain Stem Stroke, Spinal Cord Injuries (SCI), Muscular Dystrophies
- Keywords
- Assistive device, Brain Computer Interface
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Blackrock Neurotech, JHU Applied Physics Laboratory, Kennedy Krieger Institute, Baltimore, MD
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INTENT Neural Interface System | Experimental | Device: INTENT Neural Interface SystemINTENT Neural Interface System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INTENT Neural Interface SystemAlso: NeuroPort, brain-computer interface, brain computer interface, neural prosthesisUp 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. | Device | INTENT Neural Interface System |
Primary outcome
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.
3 secondary outcomes
Number of participants achieving BCI control of assistive devices
Time frame: 54 weeks
Number of participants perceiving sensory feedback
Time frame: 54 weeks
Number of microelectrodes capable of neural recording and stimulation
Time frame: 54 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathan Crone, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INTENT Neural Interface System in people with Tetraplegia/Tetraparesis and Amyotrophic Lateral Sclerosis (ALS), run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathan E Crone, MD (4109559441, ncrone@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Device-Related Adverse Events [Safety and Tolerability] (time frame: 54 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.