Investigation of Low-intensity Focused Ultrasound for Human Pain Management

NCT05145426 | Enrolling By Invitation

• 1 other identifier: 21-796
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This project examines the effects of noninvasive brain stimulation on pain. The investigators believe this study will help to better understand possible treatments for chronic pain patients. Participants undergo structural imaging, a functional Magnetic Resonance Image (fMRI) and computed tomography (CT). These images are used to align the low-intensity focused ultrasound (LIFU) device which uses sound waves to temporarily change brain activity. Pain testing is done using a small device that will increase/decrease the temperature of the skin. Brain signals are collected using electroencephalography (EEG). Heart rate, blood pressure, and skin moisture will be monitored as well.

Conditions

Chronic Pain

Keywords

Low-intensity focused ultrasound

Outcome Measures

Primary Outcomes (1)

• Perceived sensation score

  Changed perceived sensation score on a 1-10 scale in response to painful stimuli.

  Assessed per participant, over the course of participation - an average of 3 weeks.

Secondary Outcomes (2)

• Windup Pain

  Assessed per participant, over the course of participation - an average of 3 weeks

• CHEP Amplitude

  Assessed per participant, over the course of participation - an average of 3 weeks

Study Arms (1)

Pain Trials

EXPERIMENTAL

Multi visit - LIFU/Sham application, with quantitative sensory testing (using peltier device).

Device: Low Intensity Focused Ultrasound

Interventions

Low Intensity Focused Ultrasound DEVICE

Application of LIFU

Pain Trials

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:

• MRI/CT/EEG contraindications.
• Claustrophobia
• 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
• History of neurologic disorder
• History of head injury resulting in loss of consciousness for \>10 minutes.
• History of alcohol or drug dependence
• Failure to provide Social Security Number or Tax ID number. This is required for tax purposes or payment cannot be processed.

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

Fralin Biomedical Research Institute

Roanoke, Virginia, 24016, United States

Location

Related Publications (5)

• Legon W, Sato TF, Opitz A, Mueller J, Barbour A, Williams A, Tyler WJ. Transcranial focused ultrasound modulates the activity of primary somatosensory cortex in humans. Nat Neurosci. 2014 Feb;17(2):322-9. doi: 10.1038/nn.3620. Epub 2014 Jan 12.

  PMID: 24413698 BACKGROUND

• Tyler WJ. Noninvasive neuromodulation with ultrasound? A continuum mechanics hypothesis. Neuroscientist. 2011 Feb;17(1):25-36. doi: 10.1177/1073858409348066. Epub 2010 Jan 25.

  PMID: 20103504 BACKGROUND

• Kubanek J, Shukla P, Das A, Baccus SA, Goodman MB. Ultrasound Elicits Behavioral Responses through Mechanical Effects on Neurons and Ion Channels in a Simple Nervous System. J Neurosci. 2018 Mar 21;38(12):3081-3091. doi: 10.1523/JNEUROSCI.1458-17.2018. Epub 2018 Feb 20.

  PMID: 29463641 BACKGROUND

• Kamimura HA, Wang S, Chen H, Wang Q, Aurup C, Acosta C, Carneiro AA, Konofagou EE. Focused ultrasound neuromodulation of cortical and subcortical brain structures using 1.9 MHz. Med Phys. 2016 Oct;43(10):5730. doi: 10.1118/1.4963208.

  PMID: 27782686 BACKGROUND

• Legon W, Strohman A, In A, Payne B. Noninvasive neuromodulation of subregions of the human insula differentially affect pain processing and heart-rate variability: a within-subjects pseudo-randomized trial. Pain. 2024 Jul 1;165(7):1625-1641. doi: 10.1097/j.pain.0000000000003171. Epub 2024 Feb 1.

  PMID: 38314779 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Sham trials will be utilized within subject. All subjects will receive sham and ultrasound conditions.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Multiple subject repeated measures

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 6, 2021
• Study Start: February 4, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)