INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study
Synchron, Inc.
Summary
INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study
Description
The Synchron BCI motor neuroprosthesis is an implanted brain-computer interface indicated for individuals with bilateral upper-limb motor impairment, such as Amyotrophic Lateral Sclerosis (ALS). The Synchron BCI is intended to replace the function of motor neurons by detecting, translating and transmitting motor-related brain signals to restore clinically meaningful control of digital devices.
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 v…
Interventions
- DeviceStentrode
The Stentrode is an endovascular electrode array that senses electrical signals from the sensorimotor cortices.
Locations (4)
- University of Buffalo NeurosurgeryBuffalo, New York
- Mount Sinai HospitalNew York, New York
- University of Pittsburgh Medical Center (UPMC)Pittsburgh, Pennsylvania
- University of Texas Southwestern Medical Center (UTSW)Dallas, Texas