The Effects of Ultrasound on Central Nervous System

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Single (Participant)
  • Study Primary Completion Date: February 20, 2021

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

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

Arms, Groups and Cohorts

  • Experimental: Patients receiving Craniotomy
    • 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 Focused Ultrasound mapping.
  • Experimental: Epilepsy Patients
    • Patients undergoing long term monitoring for epilepsy will receive a non-invasive form of Focused Ultrasound stimulation which will be measured by their EEG cap and intracranial electrodes which are a part of their normal care.
  • Experimental: Tremor Patients receiving FUS
    • 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 Focused Ultrasound research procedure and changes in their tremor will be monitored.
  • Experimental: Tremor Patients receiving DBS
    • Patients undergoing Deep Brain Stimulation (DBS) treatment for tremor will receive a non-invasive Focused Ultrasound stimulation observed through their newly implanted electrode.
  • Experimental: Patients receiving Spinal Surgery
    • 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 Focused Ultrasound stimulation.

Clinical Trial Outcome Measures

Primary Measures

  • Electrophysiological Changes as a result of Ultrasound
    • Time Frame: baseline, 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Virginia
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Wynn Legon, PhD, Principal Investigator, University of Virginia
  • Overall Contact(s)
    • Sarah Adams, 434-243-4239, neuromodlab@hscmail.mcc.virginia.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.