INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study
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.
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.).
Single group
Stentrode
DeviceThe Stentrode is an endovascular electrode array that senses electrical signals from the sensorimotor cortices.
Device-related serious adverse events up to 180 days after implant
Device-related serious adverse events up to 1 year after implant
Target vessel patency assessed using CT venography at 180 days and 364 days after implant
Device migration assessed using CT images at 180 days and 365 days after implant
Time in days from implant to device activation
Time in days from device activation to successful demonstration of motor signal transmission.
Stability of recorded Synchron BCI signal up to 3 years after device implant
Synchron BCI use up to 1 year after device implant
Click on the lead sponsor to view all of their trials.
