Ignite Creation Date:
2024-05-06 @ 2:01 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04192149
Status:
UNKNOWN
Last Update Posted:
2019-12-10
First Post:
2019-03-19
Brief Title:
The Effects of Ultrasound on Central Nervous System
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
The Effects of Ultrasound on Central Nervous System
Status:
UNKNOWN
Status Verified Date:
2019-12
Last Known Status:
RECRUITING
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:
Focused ultrasound at low intensities is a form of neuromodulation with high spatial resolution that can be applied invasively or non-invasively using acoustic energy to affect neuronal activity The purpose of this study is to better understand the effects of low intensity focused ultrasound FUS on the central nervous system Specific patient populations within UVA health system are undergoing treatment that provide unique opportunities to study these effects
Detailed Description:
Focused ultrasound FUS at low intensities is a form of neuromodulation with high spatial resolution that can be applied invasively or non-invasively using acoustic energy to affect neuronal activity In this study the investigators intended to use specific patient populations to investigate the effects of FUS on different areas of the central nervous system CNS Each of our patients groups is undergoing a unique procedure at University of Virginia that will provide us different insights into the CNS 1 Patients receiving an awake or asleep craniotomy for brain tumors andor epilepsy will undergo a brain mapping procedure using electrical stimulation as a part of their normal care The research procedures will duplicate this mapping with an invasive FUS mapping 2 Patients undergoing long term monitoring for epilepsy will receive a non-invasive form of FUS stimulation which will be measured by their EEG cap and intracranial electrodes which are a part of their normal care 3 Patients undergoing high intensity FUS treatment for tremor will be asked to wear a research provided EEG cap while undergoing a non-invasive low intensity FUS research procedure and changes in their tremor will be monitored 4 Patients undergoing Deep Brain Stimulation DBS treatment for tremor will receive a non-invasive FUS stimulation observed through their newly implanted electrode 5 Patients receiving a spinal surgery will undergo a spinal stimulation using electrical stimulation as a part of their normal care The research procedures will duplicate this with an invasive FUS stimulation
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