Investigation of Low-intensity Focused Ultrasound Pressure

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Somatic Pain
• Intervention / Treatment: Device: low-intensity focused ultrasound - high pressure; Device: low-intensity focused ultrasound - low pressure; Device: low-intensity focused ultrasound - medium pressure

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.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Fralin Biomedical Research Institute at VTC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Understand and speak English

Exclusion Criteria:

1. Claustrophobia (scanning environment may be uncomfortable).
2. Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
3. Contraindications to CT: pregnancy
4. Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's)
5. History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor)
6. History of head injury resulting in loss of consciousness for >10 minutes.
7. History of alcohol or drug dependence (through self-report).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Safety Check - high pressure application; Small cohort to be collected prior to other study cohorts. Highest of 3 pressures of interest will be applied to the S1 (somatosensory cortex) with a follow-up MRI conducted 24-72 hours post.	Device: low-intensity focused ultrasound - high pressure; low-intensity focused ultrasound applied to the S1.
Experimental: EEG; Electrical stimulation utilized to generate SEPs, performed pre and post LIFU application. One of three LIFU pressures will be applied. One per study visit (3), randomized order. EEG collected throughout visit (outcome measure).	Device: low-intensity focused ultrasound - high pressure; low-intensity focused ultrasound applied to the S1.; 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.
Experimental: fMRI; Electrical stimulation utilized to generate SEPs, performed pre and post LIFU application. One of three LIFU pressures will be applied. One per study visit (3), randomized order. fMRI collected throughout visit (outcome measure).	Device: low-intensity focused ultrasound - high pressure; low-intensity focused ultrasound applied to the S1.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Report of Symptoms Questionnaire	questionnaire of symptomology administered pre and post intervention.	pre/post intervention and 1 week post intervention.
MRI	pre and post structural MRI collection for cohort one - evaluated by Neuroradiologist for safety considerations. Primarily looking to rule out any evidence of bleeds.	pre and post intervention in cohort 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG	Cohort 2 outcome measure is the EEG evoked potential response to the SEP stimulus pre and post LIFU application.	throughout study visits in cohort 2 - approximately 2 hours per visit across 3 study visits (~2 weeks).
fMRI	Cohort 3 outcome measure is the functional MRI response to the SEP stimulus pre and post LIFU application. The somatosensory pathway will be of most interest in analysis of the BOLD response.	throughout study visits in cohort 3 - approximately 2 hours per visit across 3 study visits (~2 weeks).

Collaborators and Investigators

• Sponsor: Virginia Polytechnic Institute and State University

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Nociceptive Pain
• Other Study ID Numbers: 24-353

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No