Investigation of Low-intensity Focused Ultrasound Pressure

NCT06343883 | Enrolling By Invitation FDA Device

• 1 other identifier: 24-353
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Somatic Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• EEG

  throughout study visits in cohort 2 - approximately 2 hours per visit across 3 study visits (~2 weeks).

• fMRI

  throughout study visits in cohort 3 - approximately 2 hours per visit across 3 study visits (~2 weeks).

Study Arms (3)

Safety Check - high pressure application

EXPERIMENTAL

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

EEG

EXPERIMENTAL

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 - low pressure; Device: low-intensity focused ultrasound - medium pressure; Device: low-intensity focused ultrasound - high pressure

fMRI

EXPERIMENTAL

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 - low pressure; Device: low-intensity focused ultrasound - medium pressure; Device: low-intensity focused ultrasound - high pressure

Interventions

low-intensity focused ultrasound - low pressure DEVICE

low-intensity focused ultrasound applied to the S1.

EEG; fMRI

low-intensity focused ultrasound - medium pressure DEVICE

low-intensity focused ultrasound applied to the S1.

EEG; fMRI

low-intensity focused ultrasound - high pressure DEVICE

low-intensity focused ultrasound applied to the S1.

EEG; Safety Check - high pressure application; fMRI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand and speak English

You may not qualify if:

• 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).

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Nociceptive Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking, no sham. All subjects will receive all conditions, all of which are active.
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Primary cohort (safety) will be collected prior to full study collection. Primary collection will involve highest pressure application and follow-up safety scans (MRI) to be reviewed by a Neuroradiologist. Once cleared - parallel design will be utilized for eeg and fMRI cohorts. Both cohorts will receive 3 LIFU pressures randomized over 3 study visits. Electrical stimulations will be applied pre and post LIFU administration to induce somatosensory evoked potentials (SEPs).

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 3, 2024
• Study Start: October 16, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)