NCT04192149

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2019

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2019

Completed
9 months until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2021

Completed
Last Updated

December 10, 2019

Status Verified

December 1, 2019

Enrollment Period

2 years

First QC Date

March 19, 2019

Last Update Submit

December 5, 2019

Conditions

Focused Ultrasound

Keywords

UltrasoundNeuromodulationFocused Ultrasound

Outcome Measures

Primary Outcomes (1)

  • Electrophysiological Changes as a result of Ultrasound

    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.

    baseline, immediately after ultrasound (same day, approximately 5-10 minutes after baseline)

Study Arms (5)

Patients receiving Craniotomy

EXPERIMENTAL

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

Epilepsy Patients

EXPERIMENTAL

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

Tremor Patients receiving FUS

EXPERIMENTAL

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

Tremor Patients receiving DBS

EXPERIMENTAL

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

Patients receiving Spinal Surgery

EXPERIMENTAL

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

Interventions

Focused UltrasoundOTHER

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

Epilepsy PatientsPatients receiving CraniotomyPatients receiving Spinal SurgeryTremor Patients receiving DBSTremor Patients receiving FUS

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unable to provide consent
  • Women who self-report pregnancy
  • Patients who are currently incarcerated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

Study Officials

  • Wynn Legon, PhD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Adams

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Within subjects design of focused ultrasound and control
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2019

First Posted

December 10, 2019

Study Start

February 19, 2019

Primary Completion

February 20, 2021

Study Completion

February 20, 2021

Last Updated

December 10, 2019

Record last verified: 2019-12

Locations

US(1)