NCT06343883

Investigation of Low-intensity Focused Ultrasound Pressure

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Virginia Polytechnic Institute and State University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Investigating the relationship between input pressure of low-intensity focused ultrasound and an evoked potential in both eeg and fMRI.

Detailed description

Study aims to determine safety and efficacy of variable pressures of low-intensity focused ultrasound using an electrical stimulation to create a somatosensory evoked potential and record eeg and fMRI outcome measures. A primary safety study will be conducted prior to 'full scale' data collection.

Conditions

• Somatic Pain

Interventions

Type	Name	Description
DEVICE	low-intensity focused ultrasound - low pressure	low-intensity focused ultrasound applied to the S1.
DEVICE	low-intensity focused ultrasound - medium pressure	low-intensity focused ultrasound applied to the S1.
DEVICE	low-intensity focused ultrasound - high pressure	low-intensity focused ultrasound applied to the S1.

Timeline

• Start date: 2024-10-16
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-04-03
• Last updated: 2025-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study