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BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia (BrainGate2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Massachusetts General Hospital
Sponsor:
Collaborators:
National Center for Medical Rehabilitation Research (NCMRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
VA Office of Research and Development
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Leigh R. Hochberg, MD, PhD., Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00912041
First received: June 1, 2009
Last updated: September 12, 2016
Last verified: September 2016

June 1, 2009
September 12, 2016
May 2009
September 2021   (final data collection date for primary outcome measure)
The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System. [ Time Frame: One year post-implant evaluation period ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00912041 on ClinicalTrials.gov Archive Site
To investigate the feasibility of BrainGate2 and to establish the parameters for a larger clinical study, such as appropriate neural decoding algorithms, sample size, indices of measurement, success criteria, and endpoints. [ Time Frame: Course of the study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility of efficacy) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.
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 to recover a host of abilities that normally rely on the hands.
Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Tetraplegia
  • Spinal Cord Injuries
  • Amyotrophic Lateral Sclerosis
  • Brain Stem Infarctions
  • Locked in Syndrome
  • Muscular Dystrophy
Device: Placement of the BrainGate2 sensor(s) into the motor-related cortex
One or two 4x4 mm BrainGate2 sensor(s) are placed into the motor-related cortex, connected to a percutaneous pedestal. 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
BrainGate
BrainGate Neural Interface System
Intervention: Device: Placement of the BrainGate2 sensor(s) into the motor-related cortex

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
December 2021
September 2021   (final data collection date for primary outcome measure)

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)
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact: Leigh R Hochberg, M.D., Ph.D. 617-724-9247 clinicaltrials@braingate.org
United States
 
NCT00912041
MGH-BG2-TP-001, R01DC009899, RC1HD063931, R01HD077220, 1UH2NS095548
Yes
Not Provided
Not Provided
Leigh R. Hochberg, MD, PhD., Massachusetts General Hospital
Leigh R. Hochberg, MD, PhD.
  • National Center for Medical Rehabilitation Research (NCMRR)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • VA Office of Research and Development
  • National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Leigh R Hochberg, M.D., PH.D. Massachusetts General Hospital
Massachusetts General Hospital
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP