NCT07543367
INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study
Recruiting · Not Applicable · Synchron, Inc. · registry updated 2026-05-11
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study
Inclusion
- 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.
Exclusion
- 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.