NCT06094205 Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)
| NCT ID | NCT06094205 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Leigh R. Hochberg, MD, PhD. |
| Condition | Anarthria |
| Study Type | INTERVENTIONAL |
| Enrollment | 2 participants |
| Start Date | 2023-10-16 |
| Primary Completion | 2027-08-31 |
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 2 participants in total. It began in 2023-10-16 with a primary completion date of 2027-08-31.
⚠ 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 goal of this study is to improve our understanding of speech production, and to translate this into medical devices called intracortical brain-computer interfaces (iBCIs) that will enable people who have lost the ability to speak fluently to communicate via a computer just by trying to speak.
Eligibility Criteria
Inclusion Criteria: * Between 18 and 80 years of age * Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders * Complete or incomplete tetraplegia (quadriplegia) * Must live within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment. (There are additional inclusion criteria) 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
Sergey Stavisky, Ph.D.
PRINCIPAL INVESTIGATOR
University of California, Davis
Frequently Asked Questions
Who can join the NCT06094205 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 NCT06094205 currently recruiting?
Yes, NCT06094205 is actively recruiting participants. Contact the research team at lhochberg@mgh.harvard.edu for enrollment information.
Where is the NCT06094205 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT06094205 clinical trial?
NCT06094205 is sponsored by Leigh R. Hochberg, MD, PhD.. The principal investigator is Sergey Stavisky, Ph.D. at University of California, Davis. The trial plans to enroll 2 participants.