NCT05303415

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Virginia Polytechnic Institute and State University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Pain

Interventions

Type	Name	Description
OTHER	Neuromodulation with low-intensity focused ultrasound	Application of LIFU to induce temporary neuromodulation, effects tested with resting state and heat evoked (QST) fMRI signals

Timeline

• Start date: 2022-05-06
• Primary completion: 2027-05-01
• Completion: 2027-12-01
• First posted: 2022-03-31
• Last updated: 2025-06-06

Locations

1 site across 1 country: United States