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BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia

NCT07791459 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2026-08-31

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 aphasia to generate text on a computer screen and audible, computer-generated speech by attempting to speak.

Conditions

  • Expressive Aphasia
  • Aphasia Following Cerebral Infarction
  • Aphasia Following Nontraumatic Intracerebral Hemorrhage
  • Aphasia Non Fluent

Interventions

DEVICE

BrainGate Neural Interface System

Up to six 4x4 mm BrainGate sensor(s) are placed into the speech or language-related cortex, connected to one, two, or three percutaneous pedestals. Neural recordings are made at least weekly for a year or more.

Sponsors & Collaborators

  • Leigh R. Hochberg, MD, PhD.

    lead OTHER

Principal Investigators

  • Leigh R Hochberg, MD, PhD · 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
2026-08-31
Primary Completion
2038-09-30
Completion
2038-12-31
FDA Device
Yes

More Related Trials

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 NCT07791459 on ClinicalTrials.gov