Study 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.Study Status:
Recruiting
Disease:
Tetraplegia , Spinal Cord Injuries , Amyotrophic Lateral Sclerosis , Brain Stem Infarctions , Locked in Syndrome , Muscular Dystrophy
Study Type:
Interventional
Type of Intervention:
Device
Intervention Name:
Placement of the BrainGate2 sensor(s) into the motor-related cortex
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Leigh R Hochberg, M.D., Ph.D., Massachusetts General Hospital
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Massachusetts General Hospital
Leigh R Hochberg, M.D., Ph.D. / email hidden; JavaScript is required / 617-724-9247
Boston, Massachusetts, 02114 United States
Full Study Summary:
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.
Study Sponsor:
Leigh R. Hochberg, MD, PhD.
Participant Duration:
approximately 13 months
Estimated Enrollment:
15
Estimated Study Start Date:
05 / 01 / 2009
Estimated Study Completion Date:
12 / 01 / 2038
Posting Last Modified Date:
01 / 10 / 2023
Date Study Added to neals.org:
06 / 03 / 2009
This study is invasive and requires surgery. You must live within 3 hours of Boston, MA, Providence, RI, Palo Alto, CA, Sacramento, CA, or Atlanta, GA.
Minimum Age:
18 Years
Maximum Age:
80 Years
Can participants use Riluzole?
Yes
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)
University of California, Davis | Recruiting
David M Brandman, MD, PhD / 916-703-5010 / email hidden; JavaScript is required
Principal Investigator : David M Brandman, MD, PhD
Sacramento, California
95817
United States
Stanford University School of Medicine | Recruiting
Jaimie Henderson, M.D. / 650-723-5574 / email hidden; JavaScript is required
Principal Investigator : Jaimie Henderson, M.D.
Stanford, California
94305
United States
Emory University School of Medicine | Recruiting
Yvan Bamps, Ph.D. / 404-778-7673 / email hidden; JavaScript is required
Principal Investigator : Nicholas Au Yong, M.D., Ph.D.
Atlanta, Georgia
30322
United States
Massachusetts General Hospital | Recruiting
Leigh R Hochberg, MD, PhD / 617-742-9247 / email hidden; JavaScript is required
Sub-Investigator : Ziv Williams, M.D., Ph.D.
Boston, Massachusetts
02114
United States
Providence VA Medical Center | Recruiting
Stephen Mernoff, M.D. / email hidden; JavaScript is required
Sub-Investigator : Leigh R Hochberg, M.D., Ph.D.
Providence, Rhode Island
02908
United States