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

ConditionPain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVirginia Polytechnic Institute and State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Neuromodulation with low-intensity focused ultrasound

    Other intervention

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

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: LIFU, heat evoked fMRI signalsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

fMRI BOLD Signals

Changes in fMRI BOLD signal

Time frame
Participant study duration, approximately 3 weeks.

Secondary outcomes

1

Changes in self-reported perceived pain

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

Time frame
Participant study duration, approximately 3 weeks.

Other outcomes

1

Monitoring changes to physiological measures

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

Time frame
Participant study duration, approximately 3 weeks.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Virginia Polytechnic Institute and State University

Lead sponsor

Source ClinicalTrials.gov
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