LIFU for Chronic Pain

NCT06628180 | Enrolling By Invitation

• 1 other identifier: 24-994
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This research project is examining the effects of noninvasive brain stimulation on chronic pain. We believe this study will help us to better understand possible treatments for chronic pain patients. Subjects will undergo functional magnetic resonance imaging (fMRI) and a computed tomography (CT) scan, which is a way to take pictures of the brain and skull. Subjects will receive noninvasive brain stimulation using low-intensity focused ultrasound (LIFU) sound waves, to temporarily change brain activity. Subjects will undergo pain testing using a small device that will increase the temperature of their skin and will rate this pain. Brain signals (EEG), heart rate and rhythm, blood pressure, respiration rate, and skin moisture will be monitored. Subjects will complete behavioral questionnaires. Each study session is expected to take 1.5-3 hours. Total participation takes 10 weeks.

Conditions

Chronic Pain

Keywords

low-intensity focused ultrasound; LIFU; tFUS

Outcome Measures

Primary Outcomes (1)

• Pain sensation

  Reduced perceived sensation (pain) score in response to painful stimulus. Pain scale of 0-10, 0 being no pain and 10 being worst pain imaginable.

  during 2 study visits - up to 8 times per visit.

Secondary Outcomes (1)

• Quality of Life

  4 weeks following each intervention, every 2-4 days, 30 min per day.

Other Outcomes (1)

• rs-fMRI

  pre and post intervention, up to 5 scans (1 pre, up to 4 post)

Study Arms (2)

Sham LIFU

SHAM COMPARATOR

Sham application of LIFU - all follow up (MRI, questionnaires) will be identical.

Device: Sham LIFU

Verum LIFU

EXPERIMENTAL

Active LIFU application with 3 week follow-up (MRI, questionnaires)

Device: LIFU

Interventions

LIFU DEVICE

Application of low-intensity focused ultrasound for neuromodulation

Verum LIFU

Sham LIFU DEVICE

Sham application of LIFU - will appear the same to participants.

Sham LIFU

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a chronic pain diagnosis. Pain must be moderate-to-severe and present for at least 3 months prior to research participation. Patients of all ethnicities, who 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

• Focused Ultrasound Foundation: collaborator
• 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

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 4, 2024
• Study Start: January 30, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)