Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

Spinal Cord Injuries Clinical Trial

— BG-Speech-01  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05724173
• Other study ID #: 2022p003220 (BG-Speech-01)
• Secondary ID: U01DC019430
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2023
• Est. completion date: December 2026

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: Leigh R Hochberg, MD, Ph.D
• Phone: 617-724-9247
• Email: lhochberg[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: December 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Brain Stem Infarctions
• Dysarthria
• Locked in Syndrome
• Locked-In Syndrome
• Motor Neuron Disease
• Muscular Dystrophies
• Quadriplegia
• Spinal Cord Injuries
• Tetraplegia

Intervention

Device:
• BrainGate Neural Interface System
Placement of the BrainGate2 sensor(s) into the speech-related cortex

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Leigh R. Hochberg, MD, PhD.	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device Safety	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: the sensors are not explanted for safety reasons during the one-year post-implant evaluation period.; 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	Device Feasibility	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: at a rate of at least 5 words per minute and; with less than a median word error rate of 50%.	At participant exit from study, or up to 5 years