Ignite Creation Date:
2024-05-06 @ 12:43 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03834857
Status:
COMPLETED
Last Update Posted:
2022-09-01
First Post:
2019-02-01
Brief Title:
SWITCH Stentrode First-in-Human Study of Implantable BCI for Control of a Digital Device
Sponsor:
Synchron Australia Pty Ltd
Organization:
Synchron Inc
Study Overview
Official Title:
Stentrode With Thought-controlled Digital Switch An Early Feasibility Study EFS of the Safety of the Stentrode Device in Participants With Loss of Motor Function Due to Paralysis
Status:
COMPLETED
Status Verified Date:
2022-08
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:
None
Brief Summary:
SWITCH Study
Detailed Description:
STENTRODE WITH THOUGHT CONTROLLED DIGITAL SWITCH An early feasibility study EFS of the safety of the StentrodeTM device in participants with loss of motor function due to paralysis from spinal cord injury motor neuron disease stroke muscular dystrophy or loss of limbs
Research has shown that in individuals with neurological conditions brain signals can be recorded using electrical sensors implanted on to the brain These signals could be used by the individuals to control assistive technology eg spelling devices that help with daily life just by thinking However implanting these electrical sensors often requires open brain surgery
A new medical device and surgical technique has been developed which allows implantation of the electrical sensors without open brain surgery The device called Stentrode is a small metallic mesh tube stent with electrode contacts small metal disks within the stent structure It can be placed inside a blood vessel of the brain located in the motor cortex This does not involve open brain surgery
The purpose of this research is to evaluate the safety of the Stentrode device in humans This is an experimental device This research will be the first of its kind to be performed in humans and may help find safer more effective ways to introduceimplant electrical sensors in patients This could foster the development of user friendly biotechnology for patients with neurological conditions
Research has shown that in individuals with neurological conditions brain signals can be recorded using electrical sensors implanted on to the brain These signals could be used by the individuals to control assistive technology eg spelling devices that help with daily life just by thinking However implanting these electrical sensors often requires open brain surgery
A new medical device and surgical technique has been developed which allows implantation of the electrical sensors without open brain surgery The device called Stentrode is a small metallic mesh tube stent with electrode contacts small metal disks within the stent structure It can be placed inside a blood vessel of the brain located in the motor cortex This does not involve open brain surgery
The purpose of this research is to evaluate the safety of the Stentrode device in humans This is an experimental device This research will be the first of its kind to be performed in humans and may help find safer more effective ways to introduceimplant electrical sensors in patients This could foster the development of user friendly biotechnology for patients with neurological conditions
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None