Actively Recruiting
Interfacing With NeuroTechnology to Expand Neural Throughput (INTENT) Device for Adults with Disabling Paralysis
Led by Johns Hopkins University · Updated on 2026-04-13
5
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
B
Blackrock Neurotech
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and early effectiveness of an implantable device designed to record and stimulate different brain areas. This device aims to help adults with disabling paralysis, such as those caused by spinal cord injury, brain stem stroke, or neuromuscular diseases like ALS, to control and receive feedback from assistive devices. This early feasibility study focuses on using intracortical microelectrodes in sensory, motor, and integrative brain regions to improve communication between the brain and assistive technologies. The study involves implanting up to eight microelectrode arrays on the motor, sensory, and integrative cortex, connected through percutaneous pedestals. Neural recording and stimulation will be performed during study visits that occur at least weekly and up to five days per week throughout the study. Participants will use the INTENT Neural Interface System to control virtual or real assistive devices and receive sensory or haptic feedback during these sessions. Participants will be involved in frequent study visits where neural activity and device function are monitored. Researchers will assess safety by tracking device-related adverse events over 54 weeks. They will also evaluate how many participants can control assistive devices, perceive sensory feedback, and maintain device functionality during this time. The study requires participants to have the ability to travel regularly and communicate reliably, and includes detailed monitoring of neurological and psychosocial status throughout the trial.
CONDITIONS
Brief Title
Interfacing With NeuroTechnology to Expand Neural Throughput (INTENT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Complete or incomplete tetraplegia, tetraparesis, severe ataxia, or disabling motor impairments in both upper limbs
- Diagnosed with brainstem stroke, traumatic spinal cord injury (C6 or higher), or progressive neuromuscular disease such as muscular dystrophy or ALS
- For traumatic SCI, upper extremity motor score of 7 or less and lower limbs with less than antigravity strength
- For progressive conditions like ALS, less than antigravity strength throughout upper limbs
- Motor impairments present for at least 12 months if due to non-progressive neurological cause
- Cleared for surgery by healthcare providers
- Ability to communicate reliably via speech or eye movement
- Stable psychosocial support with caregiver available
- Willingness and ability to travel to study location up to five days per week
- Corrected vision sufficient for computer use
You will not qualify if you...
- Psychiatric or cognitive conditions interfering with consent or participation
- Active implanted devices incompatible with MRI
- Contraindications to MRI or planned MRI during study
- Medical conditions making surgery unsafe (e.g., severe pulmonary, cardiovascular, metabolic, or renal issues)
- Chronic anticoagulation or inability to suspend it for surgery
- Conditions preventing safe chronic device implantation (e.g., infection, poorly controlled diabetes, cancer, autoimmune disorders, epilepsy, poor wound healing)
- Significant dental infection risk
- Chronic steroid or immunosuppressive therapy
- Active cancer within past year or ongoing chemotherapy
- Uncontrolled autonomic dysreflexia in past 3 months
- Hydrocephalus with or without ventricular shunt
- Other chronic unstable medical conditions
- Persistent suicidal thoughts within past year
- Substance use disorder within past year
- Pregnancy, nursing, planning pregnancy, or inadequate birth control
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo implantation of up to eight microelectrode arrays on motor, sensory, and integrative cortex connected to percutaneous pedestals.
1 surgical visit
Duration - Up to 54 weeks
Participants receive neural recording and stimulation sessions to control assistive devices and receive sensory feedback using the implanted INTENT Neural Interface System.
Weekly visits up to five days per week throughout the study
Duration - Up to 54 weeks
Participants are monitored for safety and device-related adverse events after treatment sessions.
Visits coincide with treatment visits
Trial Site Locations
Total: 1 location
1
Johns Hopkins Medicine
Baltimore, Maryland, United States, 21205
Actively Recruiting
Research Team
N
Nathan E Crone, MD
F
Francesco Tenore, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here