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The Effects of Ultrasound on Central Nervous System

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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

Tracking Information
First Submitted Date  ICMJE March 19, 2019
First Posted Date  ICMJE December 10, 2019
Last Update Posted Date December 10, 2019
Actual Study Start Date  ICMJE February 19, 2019
Estimated Primary Completion Date February 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Ultrasound on Central Nervous System
Official Title  ICMJE The Effects of Ultrasound on Central Nervous System
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Within subjects design of focused ultrasound and control
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Focused Ultrasound
Intervention  ICMJE Other: Focused Ultrasound
Low intensity focused ultrasound is sound energy stimulation at a low intensity of 1-30 W/cm2
Study Arms  ICMJE
  • 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.
    Intervention: Other: Focused Ultrasound
  • 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.
    Intervention: Other: Focused Ultrasound
  • 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.
    Intervention: Other: Focused Ultrasound
  • 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.
    Intervention: Other: Focused Ultrasound
  • 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.
    Intervention: Other: Focused Ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 5, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 20, 2021
Estimated Primary Completion Date February 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sarah Adams 434-243-4239 neuromodlab@hscmail.mcc.virginia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04192149
Other Study ID Numbers  ICMJE 21331
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wynn Legon, PhD University of Virginia
PRS Account University of Virginia
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP