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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

  • 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 - (There are additional inclusion criteria)

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 		BrainGate Neural Interface System
  • Device: Placement of the BrainGate2 sensor(s) into the motor-related cortex
    Up to six 4x4 mm BrainGate2 sensor(s) are placed into the motor-related cortex (including speech-related areas of cortex), connected to one, two, or three percutaneous pedestals. Neural recordings are made at least weekly for a year or more.
    Other names:
    • BrainGate
    • NeuroPort
    • neural prosthesis
    • neural prosthetic
    • neuroprosthetic
    • brain computer interface
    • brain-computer interface

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, M.D., Ph.D.
617-724-9247
clinicaltrials@braingate.org

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.