RecruitingNot Applicable

Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)

United States2 participantsStarted 2024-07-22

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant

Timeframe: 1 year

Trial details

NCT IDNCT06511934

SponsorLeigh R. Hochberg, MD, PhD.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-30

Contact for this trial

Leigh R Hochberg, MD, Ph.D

617-724-9247 lhochberg@mgh.harvard.edu