An interventional study of Low intensity focused ultrasound + Savoring Meditation and Low Intensity Focused Ultrasound in Fibromyalgia, sponsored by University of Virginia. Not yet recruiting. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by University of Virginia · Not applicable, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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.
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.
1,244 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 938 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →University of Virginia is the lead sponsor of 677 studies on the registry; 139 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 42 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Combination Product: Low intensity focused ultrasound + Savoring Meditation
Combination Product: Low Intensity Focused Ultrasound
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.
Also known as: liFU + SM
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.
Also known as: liFU
Safety of liFU intervention
Number of treatment-related unexpected adverse events and serious adverse events
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).
Study recruitment rate
Number of participants enrolled divided by number screened.
Time frame: Assessed from screening (Session 1; week -1) to enrollment (Session 2; week 0).
Study adherence
Number of participants to complete all Phase 1 and Phase 2 intervention sessions
Time frame: Assessed from enrollment (Session 2; week 0) to follow up (Session 12; week 11).
Study retention
Number of enrolled participants retained through the entirety of the study
Time frame: Assessed from enrollment (Session 2; week 0) to follow up (Session 12; week 11).
Nucleus accumbens activation
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.
Time frame: Assessed at Session 2 (week 0), Session 7 (week 3), and Session 11 (week 6).
Change in nucleus accumbens-ventromedial prefrontal cortex functional connectivity
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.
Time frame: Assessed at Session 2 (week 0), Session 7 (week 3), and Session 11 (week 6).
Clinical pain impact
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.
Time frame: Assessed at Session 2 (week 0), Session 7 (week 3), and Session 12 (week 11).
Clinical pain severity
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.
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).
Pain catastrophizing
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.
Time frame: Assessed at Session 2 (week 0), Session 7 (week 3), and Session 12 (week 11).
Fatigue
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.
Time frame: Assessed at Session 2 (week 0), Session 7 (week 3), and Session 12 (week 11).
Fibromyalgia Impact
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.
Time frame: Assessed at Session 2 (week 0), Session 7 (week 3), and Session 12 (week 11).
Fibromyalgia Severity
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.
Time frame: Assessed at Session 2 (week 0) and Session 7 (week 3).
Sleep quality
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.
Time frame: Assessed at Session 2 (week 0), Session 7 (week 3), and Session 12 (week 11).
Positive Affect
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.
Time frame: Assessed at Session 2 (week 0), Session 7 (week 3), and Session 12 (week 11).
Hedonic Capacity
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.
Time frame: Assessed at Session 2 (week 0), Session 7 (week 3), and Session 12 (week 11).
No study locations are listed for this record.
Plan to share: Yes
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Jan 2029, 24 months later.
Of 438 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 24 months is above that.
Counting every sponsor, half of 451 studies reached it within 15 months; a quarter within 6 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.