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
- Amyotrophic Lateral Sclerosis
- Anarthria
- Brain Stem Infarctions
- Dysarthria
- Locked in Syndrome
- Muscular Dystrophies
- Spinal Cord Injuries
- Tetraplegia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- BrainGate Neural Interface System — DEVICEPlacement 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 SystemPlacement of the BrainGate2 sensor(s) into the speech-related cortex
Primary Outcome Measure
Device Safety [ Time Frame: 1 year ]
Central Contacts
- Leigh R Hochberg, MD, Ph.D617-724-9247
- Jaimie Henderson, MD650-723-5574
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | Jaimie Henderson, M.D. (PRINCIPAL_INVESTIGATOR) |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | 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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