Investigation of Low-intensity Focused Ultrasound for Human Pain Management

Chronic Pain Clinical Trial

Official title:

Investigation of Low-intensity Focused Ultrasound for Human Pain Management

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05145426
• Other study ID #: 21-796
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 4, 2022
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Virginia Polytechnic Institute and State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Understand and speak English

Exclusion Criteria:

• MRI/CT/EEG contraindications.

1. Claustrophobia

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

5. History of neurologic disorder

6. History of head injury resulting in loss of consciousness for >10 minutes.

7. History of alcohol or drug dependence

8. Failure to provide Social Security Number or Tax ID number. This is required for tax purposes or payment cannot be processed.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Low Intensity Focused Ultrasound
Application of LIFU

Locations

Country	Name	City	State
United States	Fralin Biomedical Research Institute	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Windup Pain	Changed windup pain score on a 1-10 scale.	Assessed per participant, over the course of participation - an average of 3 weeks
Secondary	CHEP Amplitude	Attenuated N1/P1 CHEP amplitude recorded with EEG	Assessed per participant, over the course of participation - an average of 3 weeks