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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

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 (There are additional exclusion criteria)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
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

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Leigh R Hochberg, MD, PhD
617-742-9247
lhochberg@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Leigh R. Hochberg, MD, PhD.

Study Contact

Leigh R Hochberg, MD, Ph.D
617-724-9247
lhochberg@mgh.harvard.edu

Detailed Description

The goal of the BrainGate2 research and development project is to identify the core methods and features for a medical device that could allow people with paralysis, including severe speech impairment, to recover a host of abilities that normally rely on the hands or on speech.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.