Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)

Spinal Cord Injuries Clinical Trial

— BG-Speech-02  

Official title:

Understanding and Restoring Speech Production Using an Intracortical Brain-computer Interface

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06094205
• Other study ID #: 2009p000505
• Secondary ID: 1DP2DC021055
• Status: Recruiting
• Phase: N/A
• Start date: October 2024
• Est. completion date: August 31, 2027

Study information

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

Clinical Trial Summary

The goal of this study is to improve our understanding of speech production, and to translate this into medical devices called intracortical brain-computer interfaces (iBCIs) that will enable people who have lost the ability to speak fluently to communicate via a computer just by trying to speak.

Description:

The goal is to develop a new way to help people who lose the ability to speak due to neurological conditions including ALS or stroke, using an implanted medical device called a "brain-computer interface". The implanted medical device measures the person's brain activity as they try to talk and outputs their intended speech. By bypassing the injured parts of the nervous system this way, we can observe how individual brain cells are involved in speaking and working together as a network, to produce speech, and we can learn to decipher this activity to output what the person is trying to say.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders
• Complete or incomplete tetraplegia (quadriplegia)
• Must live within a three-hour drive of the Study site (There are additional inclusion criteria)

Exclusion Criteria:

• Between 18 and 80 years of age.
• The patient must be able to speak understandably or if unable to speak understandably must have one reliable means of communication.
• Complete or incomplete tetraplegia (quadriplegia)
• A minimum of twelve months elapsed post-injury and recovery must have plateaued at least 3 months prior to baseline screening.
• Per clinical opinion, a life expectancy of greater than 6 months.
• 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
• 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	University of California, Davis	Sacramento	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	Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant	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	Decoded speech output accuracy	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: The word error rate of speech that is output by the System; The phoneme error rate of speech that is output by the System	At participant exit from study, or up to 5 years