BrainGate2 for Tetraplegia and Other Motor Neuron Disorders
This study is testing the BrainGate2 Neural Interface System, which involves placing small sensors into the part of the brain that controls movement. The goal is to see if people with tetraplegia (paralysis affecting all four limbs) due to conditions like spinal cord injury, ALS, or brainstem stroke can use their thoughts to control a computer cursor and other assistive devices. Researchers want to make sure the BrainGate2 system is safe, which will be evaluated one year after the sensors are put in. The study is currently looking for up to 27 participants between 18 and 80 years old who live within a three-hour drive of the study site and have complete or incomplete tetraplegia. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 27 participants. It is not specified if it is randomized or blinded.
- What's involved
- Participants will have up to six BrainGate2 sensors placed into their motor-related cortex. Neural recordings will be made at least weekly for a year or more.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be evaluated one year after the sensors are implanted.
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BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
At a glance
Conditions
Where it's being run
6 sites across 5 statesStudy leadership
- Leigh R Hochberg, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System.One year post-implant evaluation period