Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-02-02 @ 8:09 AM
Study NCT ID:
NCT06511934
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2024-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Sponsor:
Leigh R. Hochberg, MD, PhD.
Organization:
Study Overview
Official Title:
Intuitive, Complete Neural Control of Tablet Computers for Communication
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BG-Tablet-01
Brief 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.
Detailed Description:
The goal of this project is to advance the methods by which people with tetraplegia can gain intuitive, reliable control of communication apps on industry-standard tablet computers through use of an intracortical brain-computer interface (iBCI).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U01DC017844 | NIH | None | https://reporter.nih.gov/quic… | View |