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

October 30, 2023 updated by: Leigh R. Hochberg, MD, PhD.

Single Neuron Population Dynamics in Human Speech Motor Cortex for a Speech Prosthesis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal of the BrainGate2 research and development project is to identify the core methods and features for a medical device that could allow people with paralysis, including severe speech impairment, to recover a host of abilities that normally rely on the hands or on speech.

Study Type

Interventional

Enrollment (Estimated)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University School of Medicine
        • Contact:
        • Principal Investigator:
          • Jaimie Henderson, M.D.
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Leigh R Hochberg, M.D., Ph.D.
        • Sub-Investigator:
          • Sydney S Cash, M.D., Ph.D.
        • Sub-Investigator:
          • Ziv Williams, M.D., Ph.D.
        • Sub-Investigator:
          • Daniel B Rubin, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases.
  • Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months.

Exclusion Criteria:

  1. Between 18 and 80 years of age.
  2. The patient must be able to speak understandably or if unable to speak understandably must have one reliable means of communication.
  3. Complete or incomplete tetraplegia (quadriplegia)
  4. A minimum of twelve months elapsed post-injury and recovery must have plateaued at least 3 months prior to baseline screening.
  5. Per clinical opinion, a life expectancy of greater than 6 months.
  6. Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.

(There are additional exclusion criteria)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: BrainGate Neural Interface System
Placement of the BrainGate2 sensor(s) into the speech-related cortex
Device: BrainGate Neural Interface System
Placement of the BrainGate2 sensor(s) into the speech-related cortex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Safety
Time Frame: 1 year

To determine the safety of the Sensor and overall safety of the System. Participants will be considered a success for this safety measure if they are successfully implanted with the Sensor(s) and:

  1. the sensors are not explanted for safety reasons during the one-year post-implant evaluation period.
  2. there are no device-related Serious Adverse Events that result in death or permanently increased disability during the one-year post-implant evaluation period.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Feasibility
Time Frame: At participant exit from study, or up to 5 years

The purpose of this feasibility measure is to define the metrics by which a larger trial of intracortical recording for the restoration of speech-based communication might be planned.

The secondary endpoints are:

Number of participants that are able to use the BrainGate system to communicate via speech decoding:

  1. at a rate of at least 5 words per minute and
  2. with less than a median word error rate of 50%.
At participant exit from study, or up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leigh R. Hochberg, MD, PhD.

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Jaimie Henderson, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (Actual)

February 13, 2023

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022p003220 (BG-Speech-01)
  • U01DC019430 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Amyotrophic Lateral Sclerosis

Clinical Trials on BrainGate Neural Interface System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe