Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia

NCT07226648 | Recruiting DMC FDA Device

• 1 other identifier: SPIRE1002025
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Fibromyalgia Impact Questionnaire Revised (FIQR)

  28 days following initial treatment

• Numerical Rating Scale - 11 (NRS-11) pain score response rate

  28 days following initial treatment

• Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Pain Interference Subscale

  28 days following initial treatment

• Numerical Rating Scale - 11 (NRS-11) pain score response rate

  7 days following initial treatment

• Patient Global Impression of Improvement (PGI-I)

  28 days following initial treatment

Other Outcomes (11)

• Patient-Reported Outcomes Measurement Information System (PROMIS-29) - all subscales, excluding Pain Interference

  28 days following initial treatment

• Brief Pain Inventory (BPI) - short form

  28 days following initial treatment

• Fibromyalgia Impact Questionnaire Revised (FIQR)

  16 weeks following initial treatment

Study Arms (2)

Focused Ultrasound

ACTIVE COMPARATOR

Device: Focused Ultrasound

Sham Ultrasound

SHAM COMPARATOR

Device: Focused Ultrasound

Interventions

Focused Ultrasound DEVICE

DIADEM device

Focused Ultrasound; Sham Ultrasound

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide informed consent.
• Age ≥ 22 years.
• Meets 2016 American College of Rheumatology criteria for fibromyalgia:
• Generalized pain, defined as pain in at least 4 of 5 regions, is present, AND
• Widespread pain index (WPI) ≥ 7 and symptom severity scale score (SSS) ≥ 5, or WPI of 4-6 and SSS score ≥ 9, AND
• Symptoms have been present at a similar level for at least 3 months, AND
• A diagnosis of fibromyalgia is valid irrespective of other diagnoses. A diagnosis of fibromyalgia does not exclude the presence of other clinically important illnesses.
• 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:
• Aerobic exercise like walking, cycling, and swimming,
• Water therapy/hydrotherapy with warm water exercises,
• Tai Chi involving slow, controlled movements,
• Yoga,
• Resistance training,
• Bodyweight exercises,

You may not qualify if:

• Any previous diagnosis of bipolar disorder or schizophrenia-spectrum disorder during the participant's lifetime, according to Diagnostic and Statistical Manual of Mental Disorders, version 5 (DSM-5-TR) criteria.
• New or existing diagnosis of moderate or severe alcohol or other substance use disorder in the past 6 months, according to DSM-5-TR criteria.
• New or existing diagnosis of obsessive-compulsive disorder and/or posttraumatic stress disorder in the past 30 days, according to DSM-5-TR criteria, and which is unstable in the clinical judgment of the investigator.
• New or existing primary diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder in the past 3 months, according to DSM-5-TR criteria.
• Clinically significant neurodevelopmental, neurocognitive, or personality disorder, according to DSM-5-TR criteria.
• Moderate-High Risk of Suicide, according to the Columbia-Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent (i.e., answers YES to Question 3 and NO to Question 6 (Moderate Risk), or YES to Question 4, 5, or 6 (High Risk)), or in the clinical judgement of the site investigator.
• Lifetime history of a serious suicide attempt in the medical opinion of the site investigator.
• Changes in treatment for pain in the past 2 months.
• Treatment with electroconvulsive therapy, transcranial magnetic stimulation, ketamine, or esketamine in the past 30 days.
• Currently diagnosed progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapid progressive arachnoiditis, brain or spinal cord tumor, or severe/critical spinal stenosis (stenosis).
• Cancer-related pain.
• Diagnosis of malignancy other than basal cell carcinoma, or carcinoma in situ of the cervix within the past five years, to include life expectancy less than one year due to advanced malignancy.
• Autoimmune-related pain.
• Inadequately managed general medical condition, in the opinion of the site investigator.
• Lifetime history of cerebral small vessel disease.

Sponsors & Collaborators

• University of Utah Data Coordinating Center: collaborator
• SPIRE Therapeutics Inc.: lead

Study Sites (5)

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, 55455, United States

RECRUITING

Washington University in St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

Northwell Health - The Feinstein Institutes of Clinical Research

Manhasset, New York, 10030, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84108, United States

RECRUITING

WVU Rockefeller Neuroscience Institute

Morgantown, West Virginia, 26505, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 38335553 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.

  PMID: 39073370 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.

  PMID: 39396736 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Akiko Okifuji, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Akiko Okifuji, PhD

CONTACT

801-585-7690; Akiko.Okifuji@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2025
• First Posted: November 10, 2025
• Study Start: December 11, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

US (5)