NCT05724173 Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia
| NCT ID | NCT05724173 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Leigh R. Hochberg, MD, PhD. |
| Condition | Anarthria |
| Study Type | INTERVENTIONAL |
| Enrollment | 3 participants |
| Start Date | 2023-10-18 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3 participants in total. It began in 2023-10-18 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Between 18 and 80 years of age. * Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases. * Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months. * Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment. 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)
Contact & Investigator
Jaimie Henderson, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT05724173 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Anarthria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05724173 currently recruiting?
Yes, NCT05724173 is actively recruiting participants. Contact the research team at lhochberg@mgh.harvard.edu for enrollment information.
Where is the NCT05724173 trial being conducted?
This trial is being conducted at Stanford, United States, Boston, United States.
Who is sponsoring the NCT05724173 clinical trial?
NCT05724173 is sponsored by Leigh R. Hochberg, MD, PhD.. The principal investigator is Jaimie Henderson, MD at Stanford University. The trial plans to enroll 3 participants.