RecruitingNot Applicable

Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)

United States2 participantsStarted 2023-10-16

Plain-language summary

The goal of this study is to improve our understanding of speech production, and to translate this into medical devices called intracortical brain-computer interfaces (iBCIs) that will enable people who have lost the ability to speak fluently to communicate via a computer just by trying to speak.

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: * Between 18 and 80 years of age * 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 and geographically stable for at least 15 months after enrollment. (There are additional inclusion criteria) 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 IDNCT06094205

SponsorLeigh R. Hochberg, MD, PhD.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-31

Contact for this trial

Leigh R. Hochberg, M.D., Ph.D.

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

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