Recruiting

Neural Interface

Sponsor:

Leigh R. Hochberg, MD, PhD.

Code:

NCT00912041

Conditions

Tetraplegia

Spinal Cord Injuries

Amyotrophic Lateral Sclerosis

Brain Stem Infarctions

Locked in Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief summary:

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

Tetraplegia

Spinal Cord Injuries

Amyotrophic Lateral Sclerosis

Brain Stem Infarctions

Locked in Syndrome

Study ID

NCT00912041

Start date

May, 2009

Status verified date

May, 2026

Completion date

Dec, 2038

Anticipated

Primary completion date

Sep, 2038

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

27 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: BrainGate

BrainGate Neural Interface System

Interventions

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.

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 ]

Central Contacts and Locations

Central contacts

Leigh R Hochberg, M.D., Ph.D.

617-724-9247clinicaltrials@braingate.org

Locations

University of California, Davis

Recruiting

Sacramento, California, United States, 95817

Contacts

David M Brandman, MD, PhD

916-703-5010braingate@ucdavis.edu

Principal Investigator:

David M Brandman, MD, PhD

Stanford University School of Medicine

Recruiting

Stanford, California, United States, 94305

Contacts

Jaimie Henderson, M.D.

650-723-5574henderj@stanford.edu

Principal Investigator:

Jaimie Henderson, M.D.

Emory University School of Medicine

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Yvan Bamps, Ph.D.

404-778-7673braingate@emory.edu

Principal Investigator:

Nicholas Au Yong, M.D., Ph.D.

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Leigh R Hochberg, MD, PhD

617-742-9247lhochberg@mgh.harvard.edu

Principal Investigator:

Leigh R Hochberg, M.D., Ph.D.

Providence VA Medical Center

Recruiting

Providence, Rhode Island, United States, 02908

Contacts

Stephen Mernoff, M.D.

stephen.mernoff@va.gov

Principal Investigator:

Stephen Mernoff, M.D.

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Sameer Sheth, MD, PhD

832-779-3186BrainGateStudyBCM@bcm.edu

Principal Investigator:

Sameer Sheth, MD, PhD

More Information

Sponsor

Leigh R. Hochberg, MD, PhD.

Last update posted

Jun 1, 2026

Last verified

May, 2026

Keywords

  • Brain computer interface
  • Assistive device
  • Environmental control
  • Communication device
  • quadriplegia
  • tetraplegia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Leigh R. Hochberg, MD, PhD. on 2026-06-01.