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

NCT ID: NCT06511934

Last Updated: 2025-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-22

Study Completion Date

2027-07-30

Brief Summary

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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.

Detailed Description

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The goal of this project is to advance the methods by which people with tetraplegia can gain intuitive, reliable control of communication apps on industry-standard tablet computers through use of an intracortical brain-computer interface (iBCI).

Conditions

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Brainstem Stroke ALS Tetraplegia Spinal Cord Injuries Cervical Spinal Cord Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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BrainGate Neural Interface System

Device: BrainGate Neural Interface System

Group Type EXPERIMENTAL

BrainGate Neural Interface System

Intervention Type DEVICE

Placement of the BrainGate2 sensor(s) into arm-hand motor-related cortex.

Interventions

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BrainGate Neural Interface System

Placement of the BrainGate2 sensor(s) into arm-hand motor-related cortex.

Intervention Type DEVICE

Eligibility Criteria

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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
* Prior enrollment in BrainGate2 clinical trial (NCT00912041)

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

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Brown University

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

Leigh R. Hochberg, MD, PhD.

OTHER

Sponsor Role lead

Responsible Party

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Leigh R. Hochberg, MD, PhD.

Neurologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Leigh R Hochberg, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Masssachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Leigh R Hochberg, MD, Ph.D

Role: CONTACT

617-724-9247

Facility Contacts

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Leigh R Hochberg, MD, PhD

Role: primary

617-724-9247

Other Identifiers

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U01DC017844

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2009P000505 (BG-Tablet-01)

Identifier Type: -

Identifier Source: org_study_id

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