Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)

NCT06511934 | Recruiting DMC FDA Device

• 2 other identifiers: 2009P000505 (BG-Tablet-01)U01DC017844
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

People with brainstem stroke, advanced amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), or other disorders can become unable to move or speak despite being awake and alert. In this project, the investigators seek to further translate knowledge about interpreting brain signals related to movement, and to further develop an intracortical brain-computer interface (iBCI) that could restore rapid and intuitive use of communication apps on tablet computers by people with paralysis.

Conditions

Brainstem Stroke; ALS; Tetraplegia; Spinal Cord Injuries; Cervical Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• 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: 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

Study Arms (1)

BrainGate Neural Interface System

EXPERIMENTAL

Device: BrainGate Neural Interface System

Device: BrainGate Neural Interface System

Interventions

BrainGate Neural Interface System DEVICE

Placement of the BrainGate2 sensor(s) into arm-hand motor-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:

• 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
• Prior enrollment in BrainGate2 clinical trial (NCT00912041)

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
• Brown University: collaborator
• Stanford University: collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Masssachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Brain Stem Infarctions; Quadriplegia; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Paralysis; Neurologic Manifestations; Signs and Symptoms; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Leigh R Hochberg, MD, Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leigh R Hochberg, MD, Ph.D

CONTACT

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

Study Design

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

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 22, 2024
• Study Start: July 22, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)