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

NCT ID: NCT06094205

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-16
• Study Completion Date: 2027-08-31

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

BrainGate Neural Interface System

Placement of the BrainGate2 sensor(s) into the speech-related cortex

Group Type: EXPERIMENTAL

BrainGate Neural Interface System

Intervention Type: DEVICE

Placement of the BrainGate2 sensor(s) into the speech-related cortex

Interventions

BrainGate Neural Interface System

Placement of the BrainGate2 sensor(s) into the speech-related cortex

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Between 18 and 80 years of age
• 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 and geographically stable for at least 15 months after enrollment.

Exclusion Criteria

• Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses
• Chronic oral or intravenous steroids or immunosuppressive therapy
• Other serious disease or disorder that could seriously affect ability to participate in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Leigh R. Hochberg, MD, PhD.

OTHER

Sponsor Role: lead

Responsible Party

Leigh R. Hochberg, MD, PhD.

Neurologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sergey Stavisky, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California, Davis

Sacramento, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Leigh R. Hochberg, M.D., Ph.D.

Role: CONTACT

lhochberg@mgh.harvard.edu

617-724-9247

Sergey Stavisky, Ph.D.

Role: CONTACT

sstavisky@ucdavis.edu

530-754-3413

Facility Contacts

David M Brandman, M.D.

Role: primary

dmbrandman@ucdavis.edu

916-703-5010

Sergey Stavisky, Ph.D

Role: backup

sstavisky@ucdavis.edu

530-754-3413

Other Identifiers

1DP2DC021055

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2009p000505 (BG-Speech-02)

Identifier Type: -

Identifier Source: org_study_id