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Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

NCT05724173 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-12-03

No results posted yet for this study

Summary

The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.

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

  • Jaimie Henderson, MD · Stanford University

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
2023-10-18
Primary Completion
2026-07-31
Completion
2026-12-31
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 NCT05724173 on ClinicalTrials.gov