Recruiting

Investigations of Low-Intensity Focused Ultrasound Towards Treatment for the Complex Patient

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What is being tested

Low-Intensity Focused Ultrasound

+ Low-Intensity Focused Ultrasound - sham

Device
Who is being recruted

Narcotic-Related Disorders+8

+ Anxiety Disorders

+ Mental Disorders

From 18 to 65 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: December 2024
See protocol details

Summary

Principal SponsorVirginia Polytechnic Institute and State University
Study ContactJessica Florig, MPH
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 4, 2024

Actual date on which the first participant was enrolled.

This study explores the use of Low Intensity Focused Ultrasound (LIFU) to potentially help manage pain, cravings, and anxiety in a group of patients with complex medical conditions. By understanding how LIFU affects these symptoms, the study seeks to find new ways to improve quality of life for individuals who may not respond well to traditional treatments. This research is important because managing pain, cravings, and anxiety effectively can significantly enhance daily living for those affected. Participants in this study will undergo treatment using low-intensity ultrasound technology, which is a non-invasive procedure. The study will closely monitor and measure changes in pain levels, cravings, and anxiety among participants to evaluate the effectiveness of the treatment. While the study does not focus on specific risks or benefits, it aims to gather data that could lead to better management strategies for these challenging symptoms.

Official TitleInvestigations of Low-Intensity Focused Ultrasound Towards Treatment for the Complex Patient
NCT06297200
Principal SponsorVirginia Polytechnic Institute and State University
Study ContactJessica Florig, MPH
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

25 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Narcotic-Related DisordersAnxiety DisordersMental DisordersOpioid-Related DisordersNeurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsSubstance-Related DisordersChronic PainChemically-Induced Disorders

Criteria

6 inclusion criteria required to participate
Males and females aged 18-65 years
Current diagnosis of Chronic Back Pain as defined by pain duration of at least three months, with back pain being an ongoing problem for at least half the days of the last six months.
Have evidence of central sensitization (CS) as measured by the Widespread Pain/Symptom Severity Index (WPSSI) with a score of Widespread Pain Index (WPI) ≥ 7 and Symptom Severity (SS) ≥ 5 or WPI = 3-6 and SS ≥ 9.
Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current opiate use disorder as diagnosed by the Structured Clinical Interview for DSM-5.
Show More Criteria
12 exclusion criteria prevent from participating
Evidence of neuropathic pain
Previous spine surgery
Current substance use disorder other than OUD or tobacco use disorder
Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Multi visit - LIFU/Sham. Participants will complete pain, craving, and anxiety measures pre and post intervention.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Fralin Biomedical Research Institute at VTC

Roanoke, United StatesOpen Fralin Biomedical Research Institute at VTC in Google Maps
Recruiting
One Study Center