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Low-Intensity Focused Ultrasound for Chronic Pain, Opioid Use Disorder, and Anxiety

This study is testing a device called Low-Intensity Focused Ultrasound (LIFU) to see if it can help with pain, craving, and anxiety in people who have chronic pain, opioid use disorder, and anxiety disorder. LIFU uses sound waves to stimulate the brain. You might be able to join if you are between 18 and 65 years old and have chronic back pain for at least three months, along with signs of central sensitization (when your nervous system becomes over-sensitive to pain). The researchers will be looking at any side effects you might experience and changes in your heart rate over about four weeks. The study aims to enroll 25 participants, but its current status is unclear.

Study design
This study is an interventional study, meaning participants will receive a treatment. It plans to enroll 25 participants.
What's involved
Participants will be assessed over an average of 4 weeks, including neurological exams and side effects questionnaires.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed for adverse events and heart rate changes over an average of 4 weeks.

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NCT06297200

Low-Intensity Focused Ultrasound and the Complex Patient

Recruiting
NAAges 18–65InterventionalBasic science
Virginia Polytechnic Institute and State University
~25 participants
Updated 2025-11-03 on ClinicalTrials.gov
What's tested:Low-Intensity Focused UltrasoundLow-Intensity Focused Ultrasound - sham

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events via a neurological examination
Measured over Assessed per participant, over the course of participation - an average of 4 weeks
+5 more outcomes measured

Conditions

Opioid Use Disorder
Chronic Pain
Anxiety Disorder

Explore related trials

Anxiety DisorderChronic back painOpioid Use Disorder

Where it's being run

1 sites across 1 states
Virginia1

Who to contact

Jessica Florig, MPH
[email protected]
540-526-2261
Email the study team

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What this trial measures

  • Incidence of Treatment-Emergent Adverse Events via a neurological examinationAssessed per participant, over the course of participation - an average of 4 weeks

    Any abnormal finding from the neurological exam will be recorded as an adverse event (AE) and tabulated with the side effects and tolerability data.

  • Incidence of Treatment-Emergent Adverse Events via a side effects questionnaireAssessed per participant, over the course of participation - an average of 4 weeks

    Side effects and reported severity will be tabulated and summarized on a 5 point likert scale.

  • Changes in Heart Rate (HR)Assessed per participant, over the course of participation - an average of 4 weeks

    changes in HR compared pre/post LIFU and at follow up

  • Changes in Respiration Rate (RR)Assessed per participant, over the course of participation - an average of 4 weeks

    changes in RR compared pre/post LIFU and at follow up

  • Changes in mood via visual analog mood scale (VAMS) such as the wong-baker face scale.Assessed per participant, over the course of participation - an average of 4 weeks

    changes in mood scale compared pre/post LIFU and at follow up

  • Changes in Blood Pressure (BP)Assessed per participant, over the course of participation - an average of 4 weeks

    changes in BP (systolic and diastolic) compared pre/post LIFU and at follow up