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Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)

NCT06511934 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-12-01

No results posted yet for this study

Summary

People with brainstem stroke, advanced amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), or other disorders can become unable to move or speak despite being awake and alert. In this project, the investigators seek to further translate knowledge about interpreting brain signals related to movement, and to further develop an intracortical brain-computer interface (iBCI) that could restore rapid and intuitive use of communication apps on tablet computers by people with paralysis.

Conditions

  • Brainstem Stroke
  • ALS
  • Tetraplegia
  • Spinal Cord Injuries
  • Cervical Spinal Cord Injury

Interventions

DEVICE

BrainGate Neural Interface System

Placement of the BrainGate2 sensor(s) into arm-hand motor-related cortex.

Sponsors & Collaborators

  • Brown University

    collaborator OTHER

  • Stanford University

    collaborator OTHER

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

    collaborator NIH

  • Leigh R. Hochberg, MD, PhD.

    lead OTHER

Principal Investigators

  • Leigh R Hochberg, MD, Ph.D. · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-07-22
Primary Completion
2026-07-30
Completion
2027-07-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT06511934 on ClinicalTrials.gov