Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BrainGate Neural Interface System.
- Who it may be relevant to
- Registry conditions: Brainstem Stroke, ALS, Tetraplegia, Spinal Cord Injuries. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intuitive, Complete Neural Control of Tablet Computers for Communication
Overview
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
- Device BrainGate Neural Interface System
Placement of the BrainGate2 sensor(s) into arm-hand motor-related cortex.
Primary outcome measures
- Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant [Time frame: 1 year]
Eligibility criteria
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 exclusion criteria)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
United States · 1 center
- Masssachusetts General Hospital — Boston
Identifiers
NCT: NCT06511934 · 2009P000505 (BG-Tablet-01) · U01DC017844