Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLeigh R. Hochberg, MD, PhD.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
BrainGate Neural Interface System
DevicePlacement of the BrainGate2 sensor(s) into arm-hand motor-related cortex.
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: BrainGate Neural Interface SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant
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.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Leigh R. Hochberg, MD, PhD.
Lead sponsor
Massachusetts General Hospital
Sponsor institution
Brown University
Collaborator
Stanford University
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Source ClinicalTrials.gov