Endovascular neuroprosthetic (Stentrode) to restore hand and arm control in ALS

INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study

This trial tests an implanted endovascular brain-computer interface (the Stentrode) to help people with ALS and severe arm and hand weakness control digital devices and regain functional independence.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Synchron, Inc. (Industry-sponsored)
• Locations: 5 sites (Jacksonville, Florida and 4 other locations)
• Trial ID: NCT07543367 on ClinicalTrials.gov

What this trial studies

The trial implants the Synchron Stentrode, an endovascular brain-computer interface, to detect and translate motor-related brain signals into commands for digital devices. Participants are adults with ALS and bilateral upper-limb paresis who meet imaging and vascular anatomy requirements and can undergo anesthesia. The protocol includes device implantation, creation of a subcutaneous pocket, training sessions (including home-based training with caregiver support), and repeated clinical testing visits. Imaging (CT and CT venography) is used to confirm suitable precentral gyrus and venous anatomy before enrollment.

Who should consider this trial

Good fit: Adults (22+) with ALS and bilateral upper-limb paresis, preserved precentral gyrus and suitable venous anatomy on CT/CT venography, life expectancy over 12 months, ability to undergo anesthesia, and a caregiver and home environment able to support device use and training are ideal candidates.

Not a fit: People with active infection, unsuitable vascular anatomy or brain anatomy, inability to undergo anesthesia, life expectancy under 12 months, lacking caregiver support or required English fluency, or with advanced widespread motor neuron loss are unlikely to benefit.

Why it matters

Potential benefit: If successful, the device could restore clinically meaningful control of computers and communication aids, increasing independence for people with severe arm and hand weakness from ALS.

How similar studies have performed: Early first-in-human and small pilot studies of the Stentrode and similar endovascular BCIs have shown initial feasibility and device control in a few participants, but larger controlled data remain limited.

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.

Where this trial is running

Jacksonville, Florida and 4 other locations

• Mayo Clinic — Jacksonville, Florida, United States (Recruiting)
• University of Buffalo Neurosurgery — Buffalo, New York, United States (Recruiting)
• Mount Sinai Hospital — New York, New York, United States (Recruiting)
• University of Pittsburgh Medical Center (UPMC) — Pittsburgh, Pennsylvania, United States (Not_yet_recruiting)
• University of Texas Southwestern Medical Center (UTSW) — Dallas, Texas, United States (Not_yet_recruiting)

Conditions Neurological Disorder; ALS; Motor Neuron Disease; ALS - Amyotrophic Lateral Sclerosis