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

NCT06094205 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-12-01

No results posted yet for this study

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.

Conditions

  • Anarthria
  • Dysarthria
  • Tetraplegia
  • Spinal Cord Injuries
  • Amyotrophic Lateral Sclerosis
  • Brain Stem Infarctions
  • Locked-in Syndrome
  • Muscular Dystrophies

Interventions

DEVICE

BrainGate Neural Interface System

Placement of the BrainGate2 sensor(s) into the speech-related cortex

Sponsors & Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    collaborator NIH

  • Leigh R. Hochberg, MD, PhD.

    lead OTHER

Principal Investigators

  • Sergey Stavisky, Ph.D. · University of California, Davis

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-16
Primary Completion
2027-08-31
Completion
2027-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06094205 on ClinicalTrials.gov