The Effects of Ultrasound on Central Nervous System

Focused Ultrasound Clinical Trial

Official title:

The Effects of Ultrasound on Central Nervous System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04192149
• Other study ID #: 21331
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2019
• Est. completion date: February 20, 2021

Study information

• Verified date: December 2019
• Source: University of Virginia
• Contact: Sarah Adams
• Phone: 434-243-4239
• Email: neuromodlab[@]hscmail.mcc.virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 20, 2021
• Est. primary completion date: February 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Focused Ultrasound

Intervention

Other:
• Focused Ultrasound
Low intensity focused ultrasound is sound energy stimulation at a low intensity of 1-30 W/cm2

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrophysiological Changes as a result of Ultrasound	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.	baseline, immediately after ultrasound (same day, approximately 5-10 minutes after baseline)