Low Intensity Focused Ultrasound for Patients With Fibromyalgia

November 6, 2026 updated by: Patrick Finan, PhD, University of Virginia

Early Feasibility Study of Low Intensity Focused Ultrasound Neuromodulation in Patients With Fibromyalgia

The overall goal of this study is to establish the safety and feasibility of low intensity transcranial focused ultrasound (liFU) stimulation for patients with fibromyalgia. We will also attempt to investigate the efficacy of liFU for pain and related symptoms and to compare whether liFU effects differ for people trained in different types of meditation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Following informed consent (Session 1), participants will participate in a baseline assessment (Session 2), during which they will receive a full battery of questionnaires, as well as a task-based fMRI and a baseline CT scan (the latter used for brain mapping in preparation of the liFU intervention). They will also be randomized during this session. The study is divided into two phases; in Phase 1 they will undergo four virtual sessions of a meditation intervention (either Savoring Meditation or Slow Breathing Meditation), depending on their group allocation (Session 3 to Session 6). They will then receive another assessment composed of questionnaires and a task-based fMRI (Session 7). In Phase 2 they will receive the liFU intervention (Session 8 to Session 11). At Session 11, they will also receive a post-treatment assessment composed of questionnaires and a task-based fMRI. A follow-up assessment (Session 12) four weeks after their final liFU intervention will be composed of questionnaires.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Claudia Denoue F Postdoctoral Researcher, M.D.
  • Phone Number: (434)-982-2281
  • Email: finanlab@uvahealth.org

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Females aged 18-75 years
  • Physician-confirmed diagnosis of FM according to the 2016 American College of Rheumatology criteria.
  • Willingness and ability to comply with scheduled visits and study procedures

Exclusion Criteria:

  • History of major neurological disorders
  • Current unstable psychiatric disorders or severe current substance use disorders
  • Current prescription opioid use or self -reported use of opioids in the past 30 days prior to enrollment (other medications are allowed, but must be on stable dose for at least 4 weeks)
  • Contraindications to MRI
  • Pregnancy or breastfeeding
  • Current neuromodulation therapy
  • Current meditation practice
  • Current participation in another interventional trial that could confound outcomes
  • Cannot read and speak English
  • Prisoner or cognitively impaired individuals
  • Unwilling or unable to use the internet and/or internet-enabled device to complete study procedures
  • Unable or unwilling to comply with study protocols or otherwise determined by the PI to be able to safely participate in the study.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low Intensity Focused Ultrasound + Savoring Meditation (liFU+SM)
Combination product: Low intensity focused ultrasound + Savoring Meditation

In this arm, participants first receive training in Savoring Meditation, a positive affect-focused behavioral intervention designed to enhance positive affect and support chronic pain self-management. Participants complete four 20-minute telehealth training sessions over approximately two weeks delivered by a trained interventionist. After completing the meditation training portion, participants in the liFU + SM arm complete four sessions of low-intensity focused ultrasound targeting the nucleus accumbens during which they actively practice Savoring Meditation concurrent with the sonication.

Other Names:
  • liFU + SM
Active Comparator: Low Intensity Focused Ultrasound
Combination product: Low Intensity Focused Ultrasound

In the liFU arm, participants first spend 4 telehealth sessions undergoing training in a slow breathing meditation practice. Subsequently, participants complete four in-person liFU treatment sessions over four weeks, with sequential bilateral sonications targeting the nucleus accumbens during each session. In this arm, participants do not engage in any concurrent meditation practice or other behavioral intervention during sonication. Rather, they only receive liFU sonication during those sessions.

Other Names:
  • liFU

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety of liFU intervention
Time Frame: At Session 7 (Week 3), at Sessions 8-11 (Weeks 3-6; immediately before and after each intervention and 24h after each intervention), weekly throughout weeks 7-11 and at Session 12 (Week 11).

Number of treatment-related unexpected adverse events and serious adverse events
At Session 7 (Week 3), at Sessions 8-11 (Weeks 3-6; immediately before and after each intervention and 24h after each intervention), weekly throughout weeks 7-11 and at Session 12 (Week 11).
Study recruitment rate
Time Frame: Assessed from screening (Session 1; week -1) to enrollment (Session 2; week 0).

Number of participants enrolled divided by number screened.
Assessed from screening (Session 1; week -1) to enrollment (Session 2; week 0).
Study adherence
Time Frame: Assessed from enrollment (Session 2; week 0) to follow up (Session 12; week 11).

Number of participants to complete all Phase 1 and Phase 2 intervention sessions
Assessed from enrollment (Session 2; week 0) to follow up (Session 12; week 11).
Study retention
Time Frame: Assessed from enrollment (Session 2; week 0) to follow up (Session 12; week 11).

Number of enrolled participants retained through the entirety of the study
Assessed from enrollment (Session 2; week 0) to follow up (Session 12; week 11).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nucleus accumbens activation
Time Frame: Assessed at Session 2 (week 0), Session 7 (week 3), and Session 11 (week 6).

Change in blood-oxygen-level-dependent (BOLD) signal in the nucleus accumbens, measured using functional MRI during a task that pairs meditation with noxious thermal stimulation, relative to rest. Changes will be compared between the liFU + Savoring Meditation and liFU arms.
Assessed at Session 2 (week 0), Session 7 (week 3), and Session 11 (week 6).
Change in nucleus accumbens-ventromedial prefrontal cortex functional connectivity
Time Frame: Assessed at Session 2 (week 0), Session 7 (week 3), and Session 11 (week 6).

Change in functional connectivity between the nucleus accumbens (NAc) and ventromedial prefrontal cortex (vmPFC), measured using functional MRI during a task that pairs meditation with noxious thermal stimulation, relative to rest. Changes will be compared between the liFU + Savoring Meditation and liFU arms.
Assessed at Session 2 (week 0), Session 7 (week 3), and Session 11 (week 6).
Clinical pain impact
Time Frame: Assessed at Session 2 (week 0), Session 7 (week 3), and Session 12 (week 11).

Changes in clinical pain impact will be evaluated using the Pain, Enjoyment of life, and General activity (PEG) Scale, which is a hybrid measure of pain severity and pain interference. This scale is comprised of 3 items, each rated on a numerical scale from 0-10. The total score is averaged on a scale from 0-10.
Assessed at Session 2 (week 0), Session 7 (week 3), and Session 12 (week 11).
Clinical pain severity
Time Frame: Assessed at Session 2 (week 0), Session 7 (week 3), Sessions 8-11 (Weeks 3-6; immediately after each intervention and 24h after each intervention), weekly throughout weeks 7-11, and Session 12 (week 11).

Changes in clinical pain severity will be evaluated using the Brief Pain Inventory (BPI). Average pain in the past 24 hours is rated on a scale from 0-10.
Assessed at Session 2 (week 0), Session 7 (week 3), Sessions 8-11 (Weeks 3-6; immediately after each intervention and 24h after each intervention), weekly throughout weeks 7-11, and Session 12 (week 11).
Pain catastrophizing
Time Frame: Assessed at Session 2 (week 0), Session 7 (week 3), and Session 12 (week 11).

Changes in pain catastrophizing will be evaluated using the Pain Catastrophizing Scale (PCS). The PCS is a 13-item scale, each noted on a Likert like scale from 0-4. Total scores are obtained by summing all scores, to obtain a score between 0 and 52.
Assessed at Session 2 (week 0), Session 7 (week 3), and Session 12 (week 11).
Fatigue
Time Frame: Assessed at Session 2 (week 0), Session 7 (week 3), and Session 12 (week 11).

Changes in fatigue levels will be evaluated using the Fatigue Severity Scale (FSS). The FSS is a 9-item scale, each noted on a Likert like scale from 1-7. Total scores are obtained by summing all scores, to obtain a score between 0 and 63.
Assessed at Session 2 (week 0), Session 7 (week 3), and Session 12 (week 11).
Fibromyalgia Impact
Time Frame: Assessed at Session 2 (week 0), Session 7 (week 3), and Session 12 (week 11).

Fibromyalgia Impact will be assessed using the Fibromyalgia Impact Questionnaire Revised (FIQ-R). The FIQ-R is a 21-item scale where each item is rated on a scale from 0-10 and the overall score is calculated as the addition of all items and then normalized relative to a predefined level of importance for each item. Total scores range from 0-100.
Assessed at Session 2 (week 0), Session 7 (week 3), and Session 12 (week 11).
Fibromyalgia Severity
Time Frame: Assessed at Session 2 (week 0) and Session 7 (week 3).

Fibromyalgia Severity will be assessed with the Widespread Pain Index (WPI) and the Symptom Severity Scale (SSS). The WPI counts the number of tender points reported and can range from 0 to 19. The SSS assesses 3 items on a Likert-like scale (from 0-3) as well as 3 items on a binary Yes/No scale (Yes=1, No=0). The SSS scale yields a score ranging from 0-12. In total, the WPI-SSS score is calculated by adding the WPI and the SSS score, yielding a final total score ranging from 0-31.
Assessed at Session 2 (week 0) and Session 7 (week 3).
Sleep quality
Time Frame: Assessed at Session 2 (week 0), Session 7 (week 3), and Session 12 (week 11).

Sleep quality will be assessed using the Insomnia Severity Index (ISI) and the Pittsburgh Sleep Quality Index (PSQI). The ISI is a 7-item Likert-like scale (ranging from 0-4). The total score is obtained by adding all item scores, yielding a total possible range of 0-28. The PSQI is a scale comprising of 7 different components, each of which may range from 0-3. The total score is obtained by adding all component scores, yielding a total possible range of 0-21.
Assessed at Session 2 (week 0), Session 7 (week 3), and Session 12 (week 11).
Positive Affect
Time Frame: Assessed at Session 2 (week 0), Session 7 (week 3), and Session 12 (week 11).

Changes in Positive Affect will be assessed using the Positive and Negative Affect Schedule - Expanded Form (PANAS-X). The PANAS-X consists of 60 items rated on a Likert-like scale (ranging from 1-5). Total scores are separated as General negative affective scores (ranging 10-50), General Positive Affective Scores (ranging 10-50) and a series of emotional scales with varying ranges.
Assessed at Session 2 (week 0), Session 7 (week 3), and Session 12 (week 11).
Hedonic Capacity
Time Frame: Assessed at Session 2 (week 0), Session 7 (week 3), and Session 12 (week 11).

The Snaith-Hamilton Pleasure Scale (SHAPS) is a 14-item scale where each item is rated on a Likert-like scale ranging from 0-3. Total scores are obtained by adding each item, yielding a total score ranging from 0-42.
Assessed at Session 2 (week 0), Session 7 (week 3), and Session 12 (week 11).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Virginia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Focused Ultrasound Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Patrick Finan Finan, PhD, Department of Anesthesiology, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSR 303312

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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