Study of Low-intensity Focused Ultrasound Effects on Heat Evoked fMRI Signals

NCT ID: NCT05303415

Last Updated: 2025-06-06

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

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-06

Study Completion Date

2027-12-31

Brief Summary

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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 heat evoked brain signaling using a quantitative sensory testing device. 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.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LIFU, heat evoked fMRI signals

fMRI resting and heat evoked signals performed after LIFU application to known brain region of interest or active sham region (within participant all conditions tested).

Group Type EXPERIMENTAL

Neuromodulation with low-intensity focused ultrasound

Intervention Type OTHER

Application of LIFU to induce temporary neuromodulation, effects tested with resting state and heat evoked (QST) fMRI signals

Interventions

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Neuromodulation with low-intensity focused ultrasound

Application of LIFU to induce temporary neuromodulation, effects tested with resting state and heat evoked (QST) fMRI signals

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Claustrophobia (scanning environment may be uncomfortable). Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.

Contraindications to CT: pregnancy Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's) History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor) History of head injury resulting in loss of consciousness for \>10 minutes. History of alcohol or drug dependence (through self-report).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Virginia Polytechnic Institute and State University

OTHER

Sponsor Role lead

Responsible Party

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Wynn Legon

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fralin Biomedical Research Institute

Roanoke, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jessica W Florig, MPH

Role: CONTACT

540-526-2261

Facility Contacts

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Jessica Florig, MPH

Role: primary

5405262375

Other Identifiers

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22-247

Identifier Type: -

Identifier Source: org_study_id

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