Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

Part of paid clinical trials in Stanford, California.

Sponsor
Leigh R. Hochberg, MD, PhD.
Study ID
NCT05724173
Status
Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • BrainGate Neural Interface System — DEVICE
    Placement of the BrainGate2 sensor(s) into the speech-related cortex

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
Oct 18, 2023
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

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

Arms

  • Other: BrainGate Neural Interface System
    Placement of the BrainGate2 sensor(s) into the speech-related cortex

Primary Outcome Measure

Device Safety [ Time Frame: 1 year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicineStanfordCalifornia94305
Jaimie Henderson, M.D.
650-723-5574
Jaimie Henderson, M.D. (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Leigh R Hochberg, MD, PhD
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)
Daniel B Rubin, M.D., Ph.D. (SUB_INVESTIGATOR)

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