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

First listed
Oct 23, 2023
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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