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Enrolling by Invitation

NCT Number: NCT06628180

LIFU for Chronic Pain

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

About this study

This is a 2-arm, sham-controlled, cross-over design. This study is collected over 5-7 study visits.

Initial Imaging (1): MRI and CT scans, Questionnaires, and QST Testing.

Intervention (2): Sham or verum LIFU application every 10 minutes, totaling in 8 applications. Between LIFU or Sham application quantitative sensory testing (QST) will be performed. Physiological data collection such as EEG, EDA, BP, ECG, and Respiration will be collected throughout the study visit.

Follow-Up Imaging (2-4): Following intervention sessions participants will receive a resting-state MRI. This can occur throughout the 4-weeks following an intervention visit. Participants will be scanned at least once after each intervention session.

Follow-Up Virtual Questionnaires: Following intervention sessions participants will receive a link (or a phone call if preferred) to periodically rate their pain and report on various lifestyle impacts of their chronic pain. Participants will complete these questionnaires at least twice per week in the 2 weeks following an intervention visit. These questionnaires will take less than 30 minutes.

After completing the intervention and minimum 4-week washout period, the participant will return for a second intervention visit and 3 week follow-up period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

LIFU

Device

Application of low-intensity focused ultrasound for neuromodulation

Sham LIFU

Device

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

Primary outcomes

  1. Pain sensation

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

    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.

Secondary outcomes

  1. Quality of Life

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

    quality of life questionnaires over a 4 week period following intervention

Other outcomes

  1. rs-fMRI

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

    Changes in resting state functional connectivity.

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Collaborators

  • Focused Ultrasound Foundation

Registry information

Official study title

Investigation of Accelerated LIFU: Towards Therapeutic Use for Chronic Pain

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 4, 2024
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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