Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

NCT05724173 | Recruiting DMC FDA Device

• 2 other identifiers: 2022p003220 (BG-Speech-01)U01DC019430
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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: 1. the sensors are not explanted for safety reasons during the one-year post-implant evaluation period. 2. 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 Outcomes (1)

• Device Feasibility

  At participant exit from study, or up to 5 years

Study Arms (1)

BrainGate Neural Interface System

OTHER

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

Device: BrainGate Neural Interface System

Interventions

BrainGate Neural Interface System DEVICE

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

BrainGate Neural Interface System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18 and 80 years of age.
• 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.
• Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.

You may not qualify if:

• 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

Sponsors & Collaborators

• Leigh R. Hochberg, MD, PhD.: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (2)

Stanford University School of Medicine

Stanford, California, 94305, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Dysarthria; Quadriplegia; Spinal Cord Injuries; Amyotrophic Lateral Sclerosis; Brain Stem Infarctions; Locked-In Syndrome; Muscular Dystrophies

Condition Hierarchy (Ancestors)

Articulation Disorders; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jaimie Henderson, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leigh R Hochberg, MD, Ph.D

CONTACT

617-724-9247; lhochberg@mgh.harvard.edu

Jaimie Henderson, MD

CONTACT

650-723-5574; henderj@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Neurologist

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: February 13, 2023
• Study Start: October 18, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

US (2)