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NCT Number: NCT05303415

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

Study of LIFU on fMRI pain signals. Participants receive low-intensity focused ultrasound (LIFU) and fMRI scans to measure changes in both resting and heat pain signals. Physiology may also be measured. Questionnaires and symptom monitoring will take place. The study takes place over 4 study visits.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fralin Biomedical Research Institute

Roanoke, Virginia, 24016, United States

Location status: Recruiting

Location contact

Jessica Florig, MPH

CONTACT

[email protected]

5405262375

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Neuromodulation with low-intensity focused ultrasound

Other

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

Primary outcomes

  1. fMRI BOLD Signals

    Time frame: Participant study duration, approximately 3 weeks.

    Changes in fMRI BOLD signal

Secondary outcomes

  1. Changes in self-reported perceived pain

    Time frame: Participant study duration, approximately 3 weeks.

    Change in subject perceived pain rating report on a numerical rating scale (0-10, 0 no pain, 10 worst pain)

Other outcomes

  1. Monitoring changes to physiological measures

    Time frame: Participant study duration, approximately 3 weeks.

    Monitoring for any changes to heartrate, blood pressure, respiratory rate, or galvanic skin response.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica W Florig, MPH

CONTACT

[email protected]

540-526-2261

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 31, 2022
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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