Low Intensity Focused Ultrasound for Patients With Fibromyalgia

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.

• 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.

• liFU

Number of treatment-related unexpected adverse events and serious adverse events

Number of participants enrolled divided by number screened.

Number of participants to complete all Phase 1 and Phase 2 intervention sessions

Number of enrolled participants retained through the entirety of the study

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.