NCT07543367 INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study
| NCT ID | NCT07543367 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Synchron, Inc. |
| Condition | Neurological Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-04 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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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 10 participants in total. It began in 2026-04 with a primary completion date of 2027-06.
⚠ 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
INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study
Eligibility Criteria
Inclusion Criteria: * Able to provide informed consent to participate in the study. * Diagnosis of ALS, with bilateral upper-limb paresis. * ALS must be refractory to treatment and have been present for a minimum of six months. * Aged 22 years or older. * Life expectancy greater than 12 months post-implantation. * Preserved precentral gyrus assessed using CT. * Suitable vascular anatomy assessed using CT venography. * Suitable anatomy for subcutaneous pocket creation. * Able to undergo anesthesia. * Willing and able to comply with all investigational requirements, including clinical testing visits and training visits in the home. * Caregiver(s) willing and able to facilitate study visits, including visits to the study site and in the home, and BCI use outside of study visits (e.g., device charging). * Patient and caregiver fluent in English. * Suitable home environment for BCI training. Exclusion Criteria: * Active infection or unexplained fever in the 48 hours prior to informed consent. * Major psychiatric disorder that may adversely impact the participant's safety or study compliance, including severe depression, psychotic features, personality disorder, severe emotional lability, or substance abuse. * Diagnosis of ALS-FTD or another dementia. * Active implanted device (e.g., deep brain stimulator, cardiac defibrillator, pacemaker, vagal nerve stimulator, spinal cord stimulator, diaphragmatic pacer, etc.). * Known allergy to patient-contacting materials included in the implanted device. * Contraindication to angiographic imaging or iodine contrast media. * History of central venous sinus thrombosis. * Recent history of new venous thromboembolic event (in the 6 months prior to implant), recurrent history of venous thromboembolic disease, or hypercoagulable state. * Contraindication to antithrombotic therapy. * Participant is at substantially increased risk of infection, including immunocompromised status, recurrent or chronic infection, or poorly controlled diabetes mellitus. * Significant risk of non-healing of the subcutaneous pocket incision, including history of chronic non-healing surgical wounds or poorly controlled diabetes mellitus. * Pregnant or breast feeding. * Patients who are currently enrolled in any other clinical trial that would confound interpretation of safety or effectiveness data or may interfere with the ability to meet study requirements. * Any other disease or disorder that could significantly affect participation in the study. Examples may include corrected vision insufficient for viewing computer screens or hearing insufficient for following verbal instructions, which might impact the participant's ability to participate in BCI training and testing.
Frequently Asked Questions
Who can join the NCT07543367 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Neurological Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07543367 currently recruiting?
Yes, NCT07543367 is actively recruiting participants. Visit ClinicalTrials.gov or contact Synchron, Inc. to inquire about joining.
Where is the NCT07543367 trial being conducted?
This trial is being conducted at Jacksonville, United States, Buffalo, United States, New York, United States, Pittsburgh, United States and 1 additional location.
Who is sponsoring the NCT07543367 clinical trial?
NCT07543367 is sponsored by Synchron, Inc.. The trial plans to enroll 10 participants.