Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Ultrasound on Central Nervous System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04192149
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
University of Virginia

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.

Condition or disease Intervention/treatment Phase
Focused Ultrasound Other: Focused Ultrasound Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Within subjects design of focused ultrasound and control
Masking: Single (Participant)
Primary Purpose: Other
Official Title: The Effects of Ultrasound on Central Nervous System
Actual Study Start Date : February 19, 2019
Estimated Primary Completion Date : February 20, 2021
Estimated Study Completion Date : February 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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

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

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

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

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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04192149


Contacts
Layout table for location contacts
Contact: Sarah Adams 434-243-4239 neuromodlab@hscmail.mcc.virginia.edu

Locations
Layout table for location information
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Sarah Adams    434-243-4319    neuromodlab@hscmail.mcc.virginia.edu   
Sponsors and Collaborators
University of Virginia
Investigators
Layout table for investigator information
Principal Investigator: Wynn Legon, PhD University of Virginia

Layout table for additonal information
Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT04192149    
Other Study ID Numbers: 21331
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Virginia:
Ultrasound
Neuromodulation
Focused Ultrasound