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NCT06511934 · ClinicalTrials.gov registry record · NA
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
A NA study of Spinal Cord Injuries and Tetraplegia, sponsored by Leigh R. Hochberg, MD, PhD..
- Recruiting
- Registry status
- NA
- Development phase
- 2
- Enrollment target
- 1
- Study location
NCT06511934: Recruiting NA study of Spinal Cord Injuries and Tetraplegia, sponsored by Leigh R. Hochberg, MD, PhD..
NCT06511934 is a NA study of Spinal Cord Injuries and Tetraplegia 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
NCT06511934, a NA study of Spinal Cord Injuries and Tetraplegia, 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
People with brainstem stroke, advanced amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), or other disorders can become unable to move or speak despite being awake and alert. In this project, the investigators seek to further translate knowledge about interpreting brain signals related to movement, and to further develop an intracortical brain-computer interface (iBCI) that could restore rapid and intuitive use of communication apps on tablet computers by people with paralysis.
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)
Massachusetts
- Masssachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2024-07-22 |
| Est. Completion | 2027-07-30 |
| Phase | NA |
What NCT06511934 shows while recruiting
NCT06511934 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 5 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.
NCT06511934 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06511934 about?
NCT06511934 is a clinical study titled "Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)". People with brainstem stroke, advanced amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), or other disorders can become unable to move or speak despite being awake and alert. In this project, the investigators seek to further translate knowledge about interpreting brain signals...
What is the current status of trial NCT06511934?
This trial is currently recruiting. It is a NA study. The enrollment target is 2 participants. The study started on 2024-07-22. Estimated completion is 2027-07-30.
What conditions does trial NCT06511934 study?
This clinical trial studies the following conditions: Spinal Cord Injuries, Tetraplegia, ALS, Cervical Spinal Cord Injury, Brainstem Stroke.
What interventions are being tested in trial NCT06511934?
The interventions under investigation include: BrainGate Neural Interface System (DEVICE).
Who is sponsoring clinical trial NCT06511934?
This trial is sponsored by Leigh R. Hochberg, MD, PhD., which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06511934 being conducted?
This trial has 1 study location across Massachusetts. 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 NCT06511934'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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Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)
RECRUITING · NA
-
Closed-loop Spinal Stimulation for Restoration of Upper Extremity Function After Spinal Cord Injury
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Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury
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Transcutaneous Spinal Stimulation and Exercise for Locomotion
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HAPPINESS: cHAnging the Perceived Pain INtEnSity in Populations With Spinal Cord Injury and With Health Disparities: A Feasibility Study
RECRUITING · NA
-
Dosing rTMS for Depression Post-SCI
RECRUITING · NA
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