Clinical trial NCT04192149: The Effects of Ultrasound on Central Nervous System
Official title: The Effects of Ultrasound on Central Nervous System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Focused Ultrasound
Keywords: Ultrasound
Neuromodulation
Focused Ultrasound
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Within subjects design of focused ultrasound and control
Primary purpose: OTHER

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 and/or 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.

Eligibility criteria: Inclusion Criteria:

* Be a patient receiving a treatment or surgical procedure specified below:
* Receiving a Craniotomy with brain mapping
* Receiving treatment or monitoring for Epilepsy
* Receiving either FUS or DBS treatment for Tremor
* Receiving a Spinal Surgery for stimulator placement
* Able to provide informed consent
* Must speak English
* Age 18-85

Exclusion Criteria:

* Not receiving one of the specified inclusion procedures
* Unable to provide consent
* Women who self-report pregnancy
* Patients who are currently incarcerated

Primary outcomes:
measure: Electrophysiological Changes as a result of Ultrasound
timeFrame: baseline, immediately after ultrasound (same day, approximately 5-10 minutes after baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Wynn Legon, PhD
role: PRINCIPAL_INVESTIGATOR
References: