Clinical trial for Fibromyalgia (FM)
Official title Personalized Ultrasonic Brain Stimulation for Fibromyalgia
ClinicalTrials.gov ID: NCT07361328
What this study is testing
- What it's testing
- The study wants to see if the ultrasound device can help people with fibromyalgia. It will look at safety and how the treatment feels.
- Who it's for
- Adults who have fibromyalgia and meet the study’s health criteria.
- What's involved
- Participants will visit the center 7 times for treatments and tests, including two MRI scans. They will also do online surveys 7 times. Six 45‑minute ultrasound treatments happen over two weeks.
- Time commitment
- The study lasts about 2 months, with 7 in‑person visits and 7 online assessments.
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 70
You may be able to join if
- Generalized pain, defined as pain in at least 4 of 5 regions, is present.
- Widespread pain index (WPI) ≥ 7 and symptom severity scale score (SSS) ≥ 5, or WPI of 4-6 and SSS score ≥ 9.
- Symptoms have been present at a similar level for at least 3 months.
- d.A diagnosis of fibromyalgia is valid irrespective of other diagnoses.
- Failure of at least two evidence based medications (i.e., pregabalin, duloxetine, milnacipran) for the treatment of fibromyalgia.
You likely can't join if
- Any previous diagnosis of bipolar disorder or schizophrenia-spectrum disorder during the participant's lifetime, according to Diagnostic and...
- Diagnosis of moderate or severe alcohol or other substance use disorder in the past 6 months, according to DSM-5 criteria.
- Diagnosis of obsessive compulsive disorder and/or posttraumatic stress disorder in the past 30 days, according to DSM-5 criteria, and which is...
- Primary diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder in the past 3 months, according to DSM-5 criteria.
- Clinically significant neurodevelopmental, neurocognitive, or personality disorder, according to DSM-5 criteria.
- Moderate-High Risk of Suicide, according to the Columbia-Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent (i.e., answers YES to...
See the full eligibility criteria
Who can join
- Generalized pain, defined as pain in at least 4 of 5 regions, is present.
- Widespread pain index (WPI) ≥ 7 and symptom severity scale score (SSS) ≥ 5, or WPI of 4-6 and SSS score ≥ 9.
- Symptoms have been present at a similar level for at least 3 months.
- d.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.
- 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,
- Pilates,
- Myofascial release therapy applying gentle pressure on trigger points,
- Massage therapy,
- Trigger point therapy targeting specific pain points,
- Joint mobilization,
- Postural retraining to correct body alignment,
- Balance and coordination exercises,
- Feldenkrais method for movement awareness,
- Alexander technique to enhance posture and movement efficiency,
- Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief,
- Heat therapy using hot packs, infrared, or paraffin wax,
- Cold therapy with ice packs or cryotherapy,
- Ultrasound therapy for deep tissue relaxation,
- Biofeedback to control muscle tension and pain response,
- Gentle static stretching for prolonged duration,
- Active dynamic stretching for full range of motion,
- Proprioceptive Neuromuscular Facilitation (PNF) stretching,
- Hydrotherapy pool exercises,
- Ai Chi (water-based Tai Chi),
- Underwater treadmill therapy,
- Graded motor imagery (GMI),
- Mirror therapy to retrain brain-body connections,
- Mindfulness-based stress reduction (MBSR) combining meditation and movement,
- Cognitive-behavioral therapy
- Gaze stabilization techniques for dizziness and disorientation
- Pain score of ≥ 4 on Numerical Rating Scale (NRS-11) at Screening visit.
- Pain score of ≥ 4 on Numerical Rating Scale (NRS-11) at Baseline visit.
- Stated willingness and ability to comply with all study procedures, to receive no additional interventions, and to remain on the same psychiatric treatment regimen (e.g., medication, psychotherapy) beginning at least...
- For participants of reproductive potential: negative urine or blood pregnancy test at screening; agreement to use a highly effective method of contraception (≤ 1% pregnancy rate) including tubal ligation, vasectomized...
- Willing and able to provide informed consent
What rules you out
- 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) criteria.
- Diagnosis of moderate or severe alcohol or other substance use disorder in the past 6 months, according to DSM-5 criteria.
- Diagnosis of obsessive compulsive disorder and/or posttraumatic stress disorder in the past 30 days, according to DSM-5 criteria, and which is unstable in the clinical judgment of the investigator.
- Primary diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder in the past 3 months, according to DSM-5 criteria.
- Clinically significant neurodevelopmental, neurocognitive, or personality disorder, according to DSM-5 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Salt Lake City, Utah, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.