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| Name | Class |
|---|---|
| University of Utah Data Coordinating Center | UNKNOWN |
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The goal of this clinical trial is to evaluate a new noninvasive brain stimulation intervention for fibromyalgia and to determine its effectiveness in reducing pain. Participants will receive four treatments over the course of one month and will complete surveys at multiple time points throughout the 16-week study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Focused Ultrasound | Active Comparator |
| |
| Sham Ultrasound | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focused Ultrasound | Device | DIADEM device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale - 11 (NRS-11) pain score | The NRS-11 is a scale from 0-10 with higher values representing higher levels of pain. | 28 days following initial treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Fibromyalgia Impact Questionnaire Revised (FIQR) | The FIQR is a scale ranging from 0 to 100 that evaluates function, overall impact, and symptoms of fibromyalgia over the past 7 days. Higher scores represent more severe impact to the patient. | 28 days following initial treatment |
| Numerical Rating Scale - 11 (NRS-11) pain score response rate |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) - all subscales, excluding Pain Interference | The PROMIS-29 is a 29 question survey assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and pain intensity. Scores for subscales are calculated as T-scores with a mean of 50 and a standard deviation of 10. Higher scores represent worse health than average for anxiety, depression, fatigue, sleep disturbance, and pain interference. Higher scores represent better health than average for physical function and ability to participate in social roles and activities. |
Inclusion Criteria:
Willing and able to provide informed consent.
Age ≥ 22 years.
Meets 2016 American College of Rheumatology criteria for fibromyalgia:
Failure of at least two evidence-based medications (i.e., pregabalin, duloxetine, milnacipran) for the treatment of fibromyalgia.
Failure of one or more attempts at physical or Cognitive Behavioral Therapy (CBT) including:
Pain score of ≥ 4 on Numerical Rating Scale (NRS-11) at Screening visit.
Pain score of ≥ 4 on NRS-11 at Baseline visit averaged over 3 consecutive calendar days.
Stated willingness and ability to comply with all study procedures.
Has remained on the same psychiatric treatment regimen (e.g., medication, psychotherapy) for at least one (1) month prior to screening, and has stated willingness to remain on the same regimen for the duration of the study unless a change in treatment is recommended or agreed upon by the site investigator.
For participants who could potentially become pregnant: negative urine pregnancy test at screening; agreement to use a highly effective method of contraception (≤ 1% pregnancy rate) including tubal ligation, vasectomized partner, IUD or IUS (intrauterine device or system), or long-acting contraceptives (LARC).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Akiko Okifuji, PhD | Contact | 801-585-7690 | Akiko.Okifuji@hsc.utah.edu |
| Name | Affiliation | Role |
|---|---|---|
| Akiko Okifuji, PhD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38335553 | Background | Riis TS, Losser AJ, Kassavetis P, Moretti P, Kubanek J. Noninvasive modulation of essential tremor with focused ultrasonic waves. J Neural Eng. 2024 Feb 27;21(1). doi: 10.1088/1741-2552/ad27ef. | |
| 39073370 | Background | Riis TS, Feldman DA, Losser AJ, Okifuji A, Kubanek J. Noninvasive targeted modulation of pain circuits with focused ultrasonic waves. Pain. 2024 Dec 1;165(12):2829-2839. doi: 10.1097/j.pain.0000000000003322. Epub 2024 Jul 30. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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≥ 30% reduction from baseline in NRS-11 score (the NRS-11 is a scale from 0-10 with higher values representing higher levels of pain). |
| 28 days following initial treatment |
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Pain Interference Subscale | The PROMIS-29 is a 29 question survey assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and pain intensity. The Pain Interference Subscale is scored on a 5 point scale and asks how much pain interfered with different activities (1 - Not at all; 2 - A little bit; 3 - Somewhat; 4 - Quite a bit; 5 - Very much). Scores are calculated as T-scores with a mean of 50 and a standard deviation of 10. Higher scores represent more pain interference. | 28 days following initial treatment |
| Numerical Rating Scale - 11 (NRS-11) pain score response rate | ≥ 30% reduction from baseline in NRS-11 score (the NRS-11 is a scale from 0-10 with higher values representing higher levels of pain). | 7 days following initial treatment |
| Patient Global Impression of Improvement (PGI-I) | The PGI-I is a scale from 1-7 indicating how the patient has felt overall since beginning treatment. 1 - Very Much Improved; 2 - Much Improved; 3 - Minimally Improved; 4 - No Change; 5 - Minimally Worse; 6 - Much Worse; 7 - Very Much Worse. | 28 days following initial treatment |
| Patient Health Questionnaire-9 (PHQ-9) | The PHQ-9 is a 9-question survey asking "Over the last 2 weeks, how often have you been bothered by any of the following problems?" Each question is scored as: 0: Not at all;
| 28 days following initial treatment |
| Numerical Rating Scale - 11 (NRS-11) pain score | The NRS-11 is a scale from 0-10 with higher values representing higher levels of pain. | 16 weeks following initial treatment |
| 28 days following initial treatment |
| Brief Pain Inventory (BPI) - short form | The BPI includes questions on a scale from 0-10 with higher values representing higher levels of pain or higher levels of pain interference. | 28 days following initial treatment |
| Fibromyalgia Impact Questionnaire Revised (FIQR) | The FIQR is a scale ranging from 0 to 100 that evaluates function, overall impact, and symptoms of fibromyalgia over the past 7 days. Higher scores represent more severe impact to the patient. | 16 weeks following initial treatment |
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) - all subscales | The PROMIS-29 is a 29 question survey assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and pain intensity. Scores for subscales are calculated as T-scores with a mean of 50 and a standard deviation of 10. Higher scores represent worse health than average for anxiety, depression, fatigue, sleep disturbance, and pain interference. Higher scores represent better health than average for physical function and ability to participate in social roles and activities. | 16 weeks following initial treatment |
| Patient Health Questionnaire-9 (PHQ-9) | The PHQ-9 is a 9-question survey asking "Over the last 2 weeks, how often have you been bothered by any of the following problems?" Each question is scored as: 0: Not at all;
| 16 weeks following initial treatment |
| Patient Global Impression of Improvement (PGI-I) | The PGI-I is a scale from 1-7 indicating how the patient has felt overall since beginning treatment. 1 - Very Much Improved; 2 - Much Improved; 3 - Minimally Improved; 4 - No Change; 5 - Minimally Worse; 6 - Much Worse; 7 - Very Much Worse. | 16 weeks following initial treatment |
| Brief Pain Inventory (BPI) - short form | The BPI includes questions on a scale from 0-10 with higher values representing higher levels of pain or higher levels of pain interference. | 16 weeks following initial treatment |
| Adverse Events (AEs) | Through 28 days following initial treatment |
| Serious Adverse Events (SAEs) | Through 16 weeks following initial treatment |
| Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is a semi-structured interview to assess suicidal ideation and behavior. Based on responses, participants are categorized as Low Risk, Moderate Risk, or High Risk. An increase in risk level will be evaluated. | 28 days following initial treatment |
| Montreal Cognitive Assessment (MoCA) | The MoCA is a neuropsychological screening test with scores ranging from 0-30 with lower scores suggesting higher cognitive impairment. | 28 days following initial treatment |
| University of Minnesota Medical Center Fairview | Recruiting | Minneapolis | Minnesota | 55455 | United States |
|
| Washington University in St. Louis | Recruiting | St Louis | Missouri | 63110 | United States |
|
| Northwell Health - The Feinstein Institutes of Clinical Research | Recruiting | Manhasset | New York | 10030 | United States |
|
| University of Utah | Recruiting | Salt Lake City | Utah | 84108 | United States |
|
| WVU Rockefeller Neuroscience Institute | Recruiting | Morgantown | West Virginia | 26505 | United States |
|
| 39396736 | Background | Riis TS, Feldman DA, Kwon SS, Vonesh LC, Koppelmans V, Brown JR, Solzbacher D, Kubanek J, Mickey BJ. Noninvasive Modulation of the Subcallosal Cingulate and Depression With Focused Ultrasonic Waves. Biol Psychiatry. 2025 Apr 15;97(8):825-834. doi: 10.1016/j.biopsych.2024.09.029. Epub 2024 Oct 11. |
| D009422 |
| Nervous System Diseases |