NCT07521930 Interfacing With NeuroTechnology to Expand Neural Throughput (INTENT)
| NCT ID | NCT07521930 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Tetraplegia/Tetraparesis |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2026-06 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5 participants in total. It began in 2026-06 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Nathan Crone, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT07521930 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Tetraplegia/Tetraparesis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07521930 currently recruiting?
Yes, NCT07521930 is actively recruiting participants. Contact the research team at ncrone@jhmi.edu for enrollment information.
Where is the NCT07521930 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT07521930 clinical trial?
NCT07521930 is sponsored by Johns Hopkins University. The principal investigator is Nathan Crone, MD at Johns Hopkins University. The trial plans to enroll 5 participants.