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The Effects of Ultrasound on Central Nervous System

The Effects of Ultrasound on Central Nervous System

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04192149
Enrollment
300
Registered
2019-12-10
Start date
2019-02-19
Completion date
2021-02-20
Last updated
2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focused Ultrasound

Keywords

Ultrasound, Neuromodulation, Focused Ultrasound

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.

Interventions

OTHERFocused Ultrasound

Low intensity focused ultrasound is sound energy stimulation at a low intensity of 1-30 W/cm2

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Intervention model description

Within subjects design of focused ultrasound and control

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Electrophysiological Changes as a result of Ultrasoundbaseline, immediately after ultrasound (same day, approximately 5-10 minutes after baseline)Each participant group has different type of electrophysiological recording depending on the type of procedure. Recordings will include a baseline, during ultrasound, and/or post-ultrasound electrophysiology.

Countries

United States

Contacts

Primary ContactSarah Adams
neuromodlab@hscmail.mcc.virginia.edu434-243-4239

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026