About this trial
INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.).
Trial design
Treatments tested in this trial
- Stentrode
Treatment groups
Locations
5Sponsors and collaborators
Synchron, Inc.
Lead sponsor