Actively Recruiting
INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study
Led by Synchron, Inc. · Updated on 2026-05-11
10
Participants Needed
5
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Synchron BCI motor neuroprosthesis, an implanted brain-computer interface designed for people with bilateral upper-limb motor impairment, such as those caused by Amyotrophic Lateral Sclerosis (ALS). The device aims to replace motor neuron function by detecting and transmitting brain signals to help users control digital devices. This early feasibility study focuses on understanding the safety and potential of this technology for individuals with ALS and related motor neuron diseases. The study involves implanting the Stentrode device, an endovascular electrode array that senses electrical signals from the brain's sensorimotor areas. Participants receive this implant and are then monitored over time. The study includes a single treatment arm where the device is implanted, followed by assessments at various time points up to one year post-implantation to evaluate device safety and function. Participants will be involved in clinical testing visits and training both at the study site and in their homes, supported by caregivers. Researchers will track serious adverse events related to the device up to one year after implantation. Imaging tests such as CT venography will assess the blood vessel condition and device position at six months and one year. The study duration and follow-up involve regular evaluations to monitor safety and device performance.
CONDITIONS
Brief Title
INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
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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 the Stentrode device, an endovascular electrode array that senses electrical signals from the sensorimotor cortices.
1 visit (in-person)
Duration - Up to 12 months after implantation
Participants are monitored for device-related safety, including serious adverse events and vascular assessments using imaging.
Visits at 6 months and 12 months post-implant for imaging assessments and safety monitoring
Trial Site Locations
Total: 5 locations
1
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
2
University of Buffalo Neurosurgery
Buffalo, New York, United States, 14203
Actively Recruiting
3
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
4
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
5
University of Texas Southwestern Medical Center (UTSW)
Dallas, Texas, United States, 75390
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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