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OpenTrials
Completed

NCT Number: NCT05145426

Investigation of Low-intensity Focused Ultrasound for Human Pain Management

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.

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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

Roanoke, Virginia, 24016, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Understand and speak English

Exclusion criteria

  • 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.

Treatment and study plan

Low Intensity Focused Ultrasound

Device

Application of LIFU

Primary outcomes

  1. Perceived sensation score

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

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

Secondary outcomes

  1. Windup Pain

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

    Changed windup pain score on a 1-10 scale.

  2. CHEP Amplitude

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

    Attenuated N1/P1 CHEP amplitude recorded with EEG

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2021
Registry last updated
May 27, 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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