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

Part of paid clinical trials in Sacramento, California.

Sponsor
Leigh R. Hochberg, MD, PhD.
Study ID
NCT00912041
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Placement of the BrainGate2 sensor(s) into the motor-related cortex — DEVICE
    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.

Study Details

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.

Key Dates

Start date
May 31, 2009
Status verified
May 2026
Primary completion
Sep 30, 2038
Completion
Dec 31, 2038

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: BrainGate
    BrainGate Neural Interface System

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

Locations (6)

FacilityCityStateZIPSite coordinators
University of California, DavisSacramentoCalifornia95817
David M Brandman, MD, PhD
[email protected]
916-703-5010
David M Brandman, MD, PhD (PRINCIPAL_INVESTIGATOR)
Stanford University School of MedicineStanfordCalifornia94305
Jaimie Henderson, M.D.
[email protected]
650-723-5574
Jaimie Henderson, M.D. (PRINCIPAL_INVESTIGATOR)
Emory University School of MedicineAtlantaGeorgia30322
Yvan Bamps, Ph.D.
[email protected]
404-778-7673
Nicholas Au Yong, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Leigh R Hochberg, MD, PhD
[email protected]
617-742-9247
Leigh R Hochberg, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
Sydney S Cash, M.D., Ph.D. (SUB_INVESTIGATOR)
Ziv Williams, M.D., Ph.D. (SUB_INVESTIGATOR)
Providence VA Medical CenterProvidenceRhode Island02908
Stephen Mernoff, M.D.
[email protected]
Stephen Mernoff, M.D. (PRINCIPAL_INVESTIGATOR)
Leigh R Hochberg, M.D., Ph.D. (SUB_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Sameer Sheth, MD, PhD
[email protected]
832-779-3186
Sameer Sheth, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Sacramento, CA

By research site
University of California, Davis· Sacramento, CAStanford University School of Medicine· Stanford, CAEmory University School of Medicine· Atlanta, GAMassachusetts General Hospital· Boston, MAProvidence VA Medical Center· Providence, RIBaylor College of Medicine· Houston, TX

Related Studies