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

Recruiting now · Not applicable

Conditions studied: Neurological Disorder, ALS (Amyotrophic Lateral Sclerosis), Motor Neuron Disease, ALS - Amyotrophic Lateral Sclerosis, ALS

In brief

Key facts

Study ID: NCT07543367
Run by: Synchron, Inc.
People needed: 10
Starts: 2026-04-01
Expected to finish: 2029-12-01
Last updated by the study team: 2026-05-11

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 may not qualify if…

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 it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.