Study of Low-intensity Focused Ultrasound Effects on Cognitive fMRI Signals

November 20, 2023 updated by: Wynn Legon, Virginia Polytechnic Institute and State University
Study aims to examine the effects of noninvasive brain stimulation on brain signals. This insight may have potential clinical implications for addiction, pain, and mental health populations. Participants will receive MRI and CT imaging. Participants receive low-intensity focused ultrasound (LIFU) to temporarily change brain activity. Participants then receive fMRI scans to measure changes in both resting and cognitive brain signaling using structured tasks. Heart rate, blood pressure, respiratory rate, and skin moisture is monitored. Participants complete a battery of questionnaires, both behavioral and symptom monitoring. The study takes place over 4 study visits.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy volunteers, all ethnicities, who understand and speak English.

Exclusion Criteria:

  1. Claustrophobia (scanning environment may be uncomfortable).
  2. Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
  3. Contraindications to CT: pregnancy
  4. Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's)
  5. History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor)
  6. History of head injury resulting in loss of consciousness for >10 minutes.
  7. History of alcohol or drug dependence (through self-report).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LIFU, fMRI Cognitive
fMRI resting and cognitive tasks performed after LIFU application to known brain region of interest or active sham region (within participant all conditions tested).
application of LIFU to induce temporary neuromodulation, effects tested with resting state and task based fMRI scanning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fMRI Signals - Cognition
Time Frame: Participant study duration, approximately 3 weeks.
Changes in fMRI signals of region of interest during a cognitive task
Participant study duration, approximately 3 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Executive function task performance
Time Frame: Participant study duration, approximately 3 weeks.
Testing effects of LIFU on altered task performance
Participant study duration, approximately 3 weeks.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess for changes in physiological measures
Time Frame: Participant study duration, approximately 3 weeks.
Monitoring for any changes in heartrate, blood pressure, respiratory rate, or galvanic skin response throughout testing
Participant study duration, approximately 3 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

March 4, 2022

First Submitted That Met QC Criteria

March 21, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 22-243

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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