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The Effects of Ultrasound on Central Nervous System

NCT ID: NCT04192149

Last Updated: 2019-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-19

Study Completion Date

2021-02-20

Brief Summary

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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

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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.

Conditions

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Focused Ultrasound

Keywords

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Ultrasound Neuromodulation Focused Ultrasound

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Within subjects design of focused ultrasound and control
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Focused Ultrasound

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Focused Ultrasound

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Focused Ultrasound

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Focused Ultrasound

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Focused Ultrasound

Intervention Type OTHER

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

Interventions

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Focused Ultrasound

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wynn Legon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sarah Adams

Role: CONTACT

Phone: 434-243-4239

Email: [email protected]

Facility Contacts

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Sarah Adams

Role: primary

Other Identifiers

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21331

Identifier Type: -

Identifier Source: org_study_id