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NCT06094205 · ClinicalTrials.gov registry record · NA
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)
A NA study of Spinal Cord Injuries and Amyotrophic Lateral Sclerosis, sponsored by Leigh R. Hochberg, MD, PhD..
- Recruiting
- Registry status
- NA
- Development phase
- 2
- Enrollment target
- 1
- Study location
NCT06094205: Recruiting NA study of Spinal Cord Injuries and Amyotrophic Lateral Sclerosis, sponsored by Leigh R. Hochberg, MD, PhD..
NCT06094205 is a NA study of Spinal Cord Injuries and Amyotrophic Lateral Sclerosis that is actively recruiting participants, run by Leigh R. Hochberg, MD, PhD.. The registered enrollment target is 2 participants, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06094205, a NA study of Spinal Cord Injuries and Amyotrophic Lateral Sclerosis, is actively recruiting participants, sponsored by Leigh R. Hochberg, MD, PhD..
- RECRUITING
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
To determine the safety of the Sensor and overall safety of the System. Participants will be considered a success for this safety measure if they are successfully implanted with the Sensor(s) and: 1. the sensors are not explanted for safety reasons during the one-year post-implant evaluation period. 2. there are no device-related Serious Adverse Events that result in death or permanently increased disability during the one-year post-implant evaluation period.
Conditions Studied
Interventions
- DEVICE BrainGate Neural Interface System
Study Locations (1)
California
- University of California, Davis - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2023-10-16 |
| Est. Completion | 2027-08-31 |
| Phase | NA |
What NCT06094205 shows while recruiting
NCT06094205 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (97% lower).
The record links to 8 conditions, with Spinal Cord Injuries appearing as the primary indexed condition, and to 1 intervention - of which BrainGate Neural Interface System is the first listed.
NCT06094205 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06094205 about?
NCT06094205 is a clinical study titled "Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)". 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.
What is the current status of trial NCT06094205?
This trial is currently recruiting. It is a NA study. The enrollment target is 2 participants. The study started on 2023-10-16. Estimated completion is 2027-08-31.
What conditions does trial NCT06094205 study?
This clinical trial studies the following conditions: Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Tetraplegia, Muscular Dystrophies, Dysarthria.
What interventions are being tested in trial NCT06094205?
The interventions under investigation include: BrainGate Neural Interface System (DEVICE).
Who is sponsoring clinical trial NCT06094205?
This trial is sponsored by Leigh R. Hochberg, MD, PhD., which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06094205 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Spinal Cord Injuries
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06094205's enrollment target sits among peer trials
2 201st of 202 the lowest of 202 other Spinal Cord Injuries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injuries trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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