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

Sponsor

Leigh R. Hochberg, MD, PhD. (Other)

Overall Status

Recruiting

CT.gov ID

NCT06094205

Collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anarthria Dysarthria Tetraplegia Spinal Cord Injuries Amyotrophic Lateral Sclerosis Brain Stem Infarctions Locked-in Syndrome Muscular Dystrophies	Device: BrainGate Neural Interface System	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2024

Anticipated Primary Completion Date :

Aug 31, 2027

Anticipated Study Completion Date :

Aug 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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

Arm

Intervention/Treatment

Experimental: 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

Outcome Measures

Primary Outcome Measures

Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant [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: 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.

Secondary Outcome Measures

Decoded speech output accuracy [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: The word error rate of speech that is output by the System The phoneme error rate of speech that is output by the System

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.