Recruiting

Ultrasound

Sponsor:

University of Virginia

Code:

NCT04192149

Conditions

Focused Ultrasound

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Focused Ultrasound

Study Details

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.

Conditions

Focused Ultrasound

Study ID

NCT04192149

Start date

Feb 19, 2019

Status verified date

Dec, 2019

Completion date

Feb 20, 2021

Anticipated

Primary completion date

Feb 20, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

Interventions

Focused Ultrasound

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

Primary outcome measure

  • Electrophysiological Changes as a result of Ultrasound [ Time Frame: baseline, immediately after ultrasound (same day, approximately 5-10 minutes after baseline) ]

Central Contacts and Locations

Central contacts

Sarah Adams

434-243-4239neuromodlab@hscmail.mcc.virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Sarah Adams

434-243-4319neuromodlab@hscmail.mcc.virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

Dec 10, 2019

Last verified

Dec, 2019

Keywords

  • Ultrasound
  • Neuromodulation
  • Focused Ultrasound

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2019-12-10.