Trials / Recruiting
RecruitingNCT00912041
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 27 (estimated)
- Sponsor
- Leigh R. Hochberg, MD, PhD. · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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, including severe speech impairment, to recover a host of abilities that normally rely on the hands or on speech.
Conditions
- Tetraplegia
- Spinal Cord Injuries
- Amyotrophic Lateral Sclerosis
- Brain Stem Infarctions
- Locked in Syndrome
- Muscular Dystrophy
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
Timeline
- Start date
- 2009-05-01
- Primary completion
- 2038-09-01
- Completion
- 2038-12-01
- First posted
- 2009-06-03
- Last updated
- 2025-12-03
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT00912041. Inclusion in this directory is not an endorsement.