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

Part of paid clinical trials in Sacramento, California.

Sponsor
Leigh R. Hochberg, MD, PhD.
Study ID
NCT06094205
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • BrainGate Neural Interface System — DEVICE
    Placement of the BrainGate2 sensor(s) into the speech-related cortex

Study Details

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.

Key Dates

Start date
Oct 16, 2023
Status verified
Nov 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
2 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: BrainGate Neural Interface System
    Placement of the BrainGate2 sensor(s) into the speech-related cortex

Primary Outcome Measure

Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, DavisSacramentoCalifornia95817
David M Brandman, M.D.
[email protected]
916-703-5010
Sergey Stavisky, Ph.D
[email protected]
530-754-3413

Find similar trials in Sacramento, CA

By research site
University of California, Davis· Sacramento, CA

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