NCT07226648招募中不适用
Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia: A Blinded Randomized Sham-Controlled Trial
SPIRE Therapeutics Inc.8 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年12月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 8
- 主要终点
- Numerical Rating Scale - 11 (NRS-11) pain score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 or medications that are commonly used in clinical practice to treat fibromyalgia (e.g., pregabalin, duloxetine, milnacipran, sublingual cyclobenzaprine hydrochloride, tricyclics (e.g., amitriptyline, nortriptyline, desipramine),gabapentin, gabapentinoids, NSAIDS (including Cox-2 inhibitors), acetaminophen, SSRIs, SSNIs, muscle relaxants, non-sublingual forms of cyclobenzaprine hydrochloride, opioids, benzodiazepines), at least 1 of which is FDA-approved for the treatment of fibromyalgia (e.g., pregabalin, duloxetine, milnacipran, and sublingual cyclobenzaprine hydrochloride).
- •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,
- •Resistance training,
- •Bodyweight exercises,
- •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, aa) Graded motor imagery (GMI), bb) Mirror therapy to retrain brain-body connections, cc) Mindfulness-based stress reduction (MBSR) combining meditation and movement, dd) Balance exercises to improve stability, ee)Gaze stabilization techniques for dizziness and disorientation, ff) CBT.
- •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 either abstain from heterosexual intercourse or use an acceptable contraceptive method during study participation. Acceptable contraceptive methods include hormonal contraception, including oral contraceptive pills, tubal ligation, vasectomized partner, IUD or IUS (intrauterine device or system), or long-acting reversible contraceptives (LARC).
排除标准
- •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 prescribed treatments for pain in the past 2 months that could confound study outcome assessments, in the opinion of the site investigator.
- •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 conditions that are known to cause pain.
- •Inadequately managed general medical condition, in the opinion of the site investigator.
- •Lifetime history of cerebral small vessel disease.
- •Lifetime history of intracranial hemorrhage.
- •Pregnant or breast feeding.
- •MRI contraindication or electrically sensitive implants such as pacemakers, implanted cardioverter defibrillators, or neurostimulators. Routine dental hardware is not exclusionary.
- •MRI intolerance.
- •Previously enrolled in a DIADEM clinical trial. Note: a patient who screen fails is able to be rescreened at most one time.
- •Has a history of a medical or psychiatric disorder, disease, condition, injury, symptoms, or circumstance that, in the opinion of the site investigator, may (1) reduce the participant's ability to fulfill the study requirements as per protocol; (2) adversely impact the integrity of the data or the validity of the study results; or (3) pose an increased risk to the participant during study participation.
- •Participants with braids, dreadlocks, or other hairstyles that prevent access to the side of the head and who are unwilling to temporarily adjust their hairstyle to allow such access.
研究组 & 干预措施
Sham Ultrasound
Sham Comparator
干预措施: Focused Ultrasound (Device)
Focused Ultrasound
Active Comparator
干预措施: Focused Ultrasound (Device)
结局指标
主要结局
Numerical Rating Scale - 11 (NRS-11) pain score
时间窗: 28 days following initial treatment
The NRS-11 is a scale from 0-10 with higher values representing higher levels of pain.
次要结局
- Fibromyalgia Impact Questionnaire Revised (FIQR)(28 days following initial treatment)
- Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Pain Interference Subscale(28 days following initial treatment)
- Patient Global Impression of Improvement (PGI-I)(28 days following initial treatment)
- Patient Health Questionnaire-9 (PHQ-9)(28 days following initial treatment)
- Fibromyalgia Impact Questionnaire Revised (FIQR)(28 days following initial treatment)
- Numerical Rating Scale - 11 (NRS-11) pain score response rate(7 days following initial treatment)
- Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Pain Interference Subscale(28 days following initial treatment)
- Patient Global Impression of Improvement (PGI-I)(28 days following initial treatment)
- Patient Health Questionnaire-9 (PHQ-9)(28 days following initial treatment)
- Numerical Rating Scale - 11 (NRS-11) pain score(16 weeks following initial treatment)
- Numerical Rating Scale - 11 (NRS-11) pain score response rate(28 days following initial treatment)
研究者
研究点 (8)
Loading locations...
相似试验
招募中
不适用
Apathy in Parkinson Disease TMS StudyParkinson DiseaseNCT06087926University of North Carolina, Chapel Hill100
终止
不适用
A Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - University of MichiganFibromyalgiaNCT01914679University of Michigan17
招募中
不适用
Transcranial Stimulation Combined With Auditory TrainingDifficulties Understanding Speech in NoiseNCT06738030Boston University Charles River Campus94
已完成
不适用
Non-invasive Blood-brain Barrier Opening in Alzheimer's Disease Patients Using Focused UltrasoundAlzheimer DiseaseNCT04118764Columbia University6
已完成
不适用
Non-invasive Brain Stimulation and Injury Risk BiomechanicsConcussion, MildNCT06093295University of Georgia40