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

10 Participants
are divided into 1 treatment group

Locations

5
Mayo Clinic32224, JacksonvilleFlorida, United States
University of Buffalo Neurosurgery14203, BuffaloNew York, United States
Mount Sinai Hospital10029, New YorkNew York, United States
University of Pittsburgh Medical Center (UPMC)15213, PittsburghPennsylvania, United States

Sponsors and collaborators

Synchron, Inc.

Lead sponsor