Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-31 @ 4:23 AM
Study NCT ID:
NCT06944834
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-25
First Post:
2025-04-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on the Safety and Functionality of the Implantable Wireless Brain-Computer Interfaces for Motor Rehabilitation
Sponsor:
Shanghai StairMed Technology Co., Ltd.
Organization:
Study Overview
Official Title:
A Study on the Safety and Functionality of the Implantable Wireless Brain-Computer Interfaces for Motor Rehabilitation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-03
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:
STAIR
Brief Summary:
The objective of this study is to evaluate the safety and efficacy of minimally invasive, wireless brain-machine interface system (WRS) in patients with paralysis (resulting from spinal cord injuries, brainstem strokes, amyotrophic lateral sclerosis, or other motor neuron diseases causing complete or incomplete quadriplegia) or bilateral upper limb amputations. By leveraging brain-machine interface alternative technology, participants can use brain signals to control external devices (such as moving cursors, wheelchairs, robotic arms, WeChat Mini Programs, and other physical assistive devices), thereby improving their motor function and quality of life.
Detailed Description:
The objective of this study is to evaluate the safety and efficacy of minimally invasive, wireless brain-machine interface system (WRS) in patients with paralysis (resulting from spinal cord injuries, brainstem strokes, amyotrophic lateral sclerosis, or other motor neuron diseases causing complete or incomplete quadriplegia) or bilateral upper limb amputations. By leveraging brain-machine interface alternative technology, participants can use brain signals to control external devices (such as moving cursors, wheelchairs, robotic arms, WeChat Mini Programs, and other physical assistive devices), thereby improving their motor function and quality of life.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| JJ202503-01 | OTHER | IEC of Institution for National Drug Clinical Trials, Tangdu Hospital, Fourth Military Medical University | View |