Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia
ConditionFibromyalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorSPIRE Therapeutics Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willing and able to provide informed consent.
Age ≥ 22 years.
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Focused Ultrasound
DeviceDIADEM device
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Focused UltrasoundActive comparator 1 intervention
Group B: Sham UltrasoundSham comparator 1 intervention
Trial outcomes
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.
Time frame
28 days following initial treatmentSecondary outcomes
1
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.
Time frame
28 days following initial treatment2
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).
Time frame
28 days following initial treatment3
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.
Time frame
28 days following initial treatment4
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).
Time frame
7 days following initial treatmentOther outcomes
1
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.
Time frame
28 days following initial treatment2
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.
Time frame
28 days following initial treatment3
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.
Time frame
16 weeks following initial treatment4
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.
Time frame
16 weeks following initial treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
SPIRE Therapeutics Inc.
Lead sponsor
University of Utah Data Coordinating Center
Collaborator
Source ClinicalTrials.gov