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

Study Purpose:

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 Status:



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

Study Type:


Type of Intervention:


Intervention Name:

BrainGate Neural Interface System




Study Chair(s)/Principal Investigator(s):

Jaimie Henderson, MD, Stanford University ID:


Neals Affiliated?


Coordinating Center Contact Information

Leigh R Hochberg, MD, Ph.D / email hidden; JavaScript is required / 617-724-9247

Full Study Summary:

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 Sponsor:

Leigh R. Hochberg, MD, PhD.

Estimated Enrollment:


Estimated Study Start Date:

03 / 21 / 2023

Estimated Study Completion Date:

12 / 01 / 2026

Posting Last Modified Date:

04 / 05 / 2023

Date Study Added to

02 / 13 / 2023

Minimum Age:

18 Years

Maximum Age:

75 Years

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 75 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)

Stanford University School of Medicine | Recruiting

Jaimie Henderson, M.D. / 650-723-5574 / email hidden; JavaScript is required

Principal Investigator : Jaimie Henderson, M.D.

Stanford, California 94305
United States

Massachusetts General Hospital | Recruiting

Leigh R Hochberg, MD, PhD / 617-742-9247 / email hidden; JavaScript is required

Sub-Investigator : Daniel B Rubin, M.D., Ph.D.

Boston, Massachusetts 02114
United States