Actively Recruiting
Interfacing With NeuroTechnology to Expand Neural Throughput (INTENT)
Led by Johns Hopkins University · Updated on 2026-04-13
5
Participants Needed
1
Research Sites
130 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
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
Official 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, muscular dystrophy, ALS, or similar progressive neuromuscular disease
- Traumatic spinal cord injury candidates must have injury at or above C6 with ASIA Impairment Scale A, B, or C
- Upper extremity motor score of 7 or less and less than antigravity strength (<3) in lower limbs for non-progressive neurological disorders
- Less than antigravity strength (<3) in upper limbs for progressive conditions like ALS
- Motor impairments present for at least 12 months if due to non-progressive causes
- Meet surgical safety criteria and have surgical clearance
- Ability to communicate reliably (speech or eye movement)
- Stable psychosocial support with a capable caregiver
- Willingness and ability to travel up to five days per week for the study
- Ability to understand and follow study instructions
- Corrected vision sufficient to use a computer monitor
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 need for MRI during study
- Medical conditions making surgery unsafe (e.g., severe pulmonary, cardiovascular, metabolic, or renal impairments)
- Chronic anticoagulation without safe suspension for surgery
- Conditions contraindicating chronic device implantation (e.g., osteomyelitis, chronic infection, poorly controlled diabetes, cancer, severe autoimmune disorder, epilepsy, poor wound healing)
- Significant dental or periodontal infection risk
- Chronic steroid or immunosuppressive therapy
- Active cancer or chemotherapy within past year
- Uncontrolled autonomic dysreflexia in past 3 months
- Hydrocephalus with or without shunt
- Other unstable medical conditions affecting participation
- Persistent suicidal thoughts in past 12 months
- Substance use disorder in past year
- Pregnancy, nursing, planning pregnancy, or not using adequate birth control
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Johns Hopkins Medicine
Baltimore, Maryland, United States, 21205
Actively Recruiting
Research Team
N
Nathan E Crone, MD
CONTACT
F
Francesco Tenore, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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