ALS, Brainstem Stroke, Cervical Spinal Cord Injury, Spinal Cord Injuries, Tetraplegia
Conditions
Brief summary
People with brainstem stroke, advanced amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), or other disorders can become unable to move or speak despite being awake and alert. In this project, the investigators seek to further translate knowledge about interpreting brain signals related to movement, and to further develop an intracortical brain-computer interface (iBCI) that could restore rapid and intuitive use of communication apps on tablet computers by people with paralysis.
Detailed description
The goal of this project is to advance the methods by which people with tetraplegia can gain intuitive, reliable control of communication apps on industry-standard tablet computers through use of an intracortical brain-computer interface (iBCI).
Interventions
Placement of the BrainGate2 sensor(s) into arm-hand motor-related cortex.
Sponsors
Leigh R. Hochberg, MD, PhD.
Brown University
Stanford University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders * Complete or incomplete tetraplegia (quadriplegia) * Must live within a three-hour drive of the Study site * Prior enrollment in BrainGate2 clinical trial (NCT00912041)
Exclusion criteria
* Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses * Chronic oral or intravenous steroids or immunosuppressive therapy * Other serious disease or disorder that could seriously affect ability to participate in the study (There are additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant | 1 year | To determine the safety of the Sensor and overall safety of the System. Participants will be considered a success for this safety measure if they are successfully implanted with the Sensor(s) and: 1. the sensors are not explanted for safety reasons during the one-year post-implant evaluation period. 2. there are no device-related Serious Adverse Events that result in death or permanently increased disability during the one-year post-implant evaluation period. |
Countries
United States
Contacts
CONTACTLeigh R Hochberg, MD, Ph.D
PRINCIPAL_INVESTIGATORLeigh R Hochberg, MD, Ph.D.
Massachusetts General Hospital
Outcome results
None listed