Pain & Reward Neuromodulation of CNS Circuits
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity
研究概览
简要总结
This pilot feasibility study aims to evaluate transcranial magnetic stimulation (TMS) targeting the prefrontal cortex in patients with fibromyalgia syndrome (FMS). The study will assess preliminary efficacy and mechanisms of central nervous system changes using neuroimaging, behavioral tasks, sensory testing, and neuroimmune markers. Participants will undergo MRI scans, multi-day TMS sessions, and complete questionnaires. The goal is to generate pilot data for future trials on neuromodulation for chronic pain.
详细描述
This is a study to compare activity in the brains of female adults with chronic pain before and after a new intervention. What the researchers learn by doing this study may help them understand how the brain works and how to develop new and targeted treatments for adults with chronic pain.
Female participants in this study will come to Duke Hospital for up to 6 visits. First, there is an MRI scan visit. Then, there are 4 intervention (TMS) visits, one after the other over 4 days. Next, there is an identical follow up MRI scan visit. Afterwards, there is a one month, three month, and six month follow up that can be completed remotely.
During each of 2 MRI study visits, participants will:
- Have a urine test for drug use (and pregnancy if applicable)
- Have a blood draw to measure inflammation and/or genetic testing
- Have magnetic resonance imaging (MRI) scans of the brain and spine
- Complete behavior tests (participate in games or tasks), sensory tests, and questionnaires
During each of 4 TMS study visits, participants will:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusions:
- •Female and ages 18 +
- •Ability to read/understand English and give consent to participate
- •Physician diagnosis & confirmation of primary fibromyalgia syndrome
- •Verbal agreement to maintain dose of prescribed medication (if any) constant throughout the study, except exclusion medication and except if there is a medical emergency requiring changes in medication
- •If enrolled in psychotherapy, verbal agreement to maintain (not change or stop) the psychotherapy during the study
- •Absence of use of opioid medications (during the previous 90 days, and no greater than a 30-day period during lifetime)
- •Exclusions:
- •limited ability to participate fully in behavioral tasks, longitudinal follow-up (e.g., plans to move out-of-state within 3 months)
- •MRI contraindication (e.g., metal implants, claustrophobia, pregnant or planning to become pregnant)
- •any factors that at the discretion of the investigators would adversely affect the participant or the integrity of the study (e.g., ongoing legal action or disability claim regarding pain, uncontrolled psychiatric disorder, head/neck injury, use of certain medications)
- •TMS-Specific Exclusions:
- •1. TMS contraindication (e.g., history of seizures, medications contraindicated for risks/efficacy of TMS procedures)
- •current hypomania,
- •meets diagnostic criteria for current psychotic disorder, or psychotic features,
- •meets diagnostic criteria for Bipolar I disorder,
- •meets diagnostic criteria for current alcohol or substance use disorder (moderate and high severity)
- •current uncontrolled anorexia or other condition requiring hospitalization,
- •current serious medical illness, including current severe migraine headaches,
- •changed psychotropic medications in the prior 2 months, or plans to change medication during the study,
- •history of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesion, devices that may be affected by TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator),
- •conditions associated with increased intracranial pressure, space occupying brain lesion, transient ischemic attack, cerebral aneurysm, dementia, Parkinson's or Huntington's disease, multiple sclerosis,
- •use of investigational drug or devices within 4 weeks of screening,
- •cochlear implants,
- •Only females will be enrolled in this study because it focuses on patients who have fibromyalgia which is more prevalent (both diagnosed and self-reported) in females.
- •Due to the contributions of hormones to the conditions under study in this project, female eligibility in this study will be defined as an individual who is female sex at birth and currently female sex
排除标准
- 未提供
研究组 & 干预措施
Active TMS
Participants receive TMS over 4 consecutive days (20 sessions total).
干预措施: Transcranial Magnetic Stimulation (TMS) (Device)
结局指标
主要结局
Change in Pain Intensity
时间窗: Baseline MRI and post-intervention MRI (approximately 3 weeks)
PROMIS Short Form - Pain Intensity (3a) is a 3-item measure which includes questions of pain at its worst (past 7 days), average pain (past 7 days), and pain right now (at time of survey). Each item is rated from No Pain (1) to Very Severe (5).
Change in Fatigue
时间窗: Baseline MRI and post-intervention MRI (approximately 3 weeks)
The PROMIS Fatigue Computer Adaptive Test (CAT) is a dynamic, patient-reported outcome tool that measures fatigue severity (intensity, frequency, and impact) over the past seven days. Using item response theory (IRT), it selects the next best question based on previous answers, typically requiring only 4-6 items to produce highly precise, reliable scores while minimizing patient burden. Scoring: Results are reported as T-scores, where 50 is the general population mean and 10 is the standard deviation. A T-score of 60 or higher is one standard deviation worse than average.
Change in FMS-related brain/fibro fog as measured by the Montreal Cognitive Assessment (MoCA)
时间窗: Baseline MRI and post-intervention MRI (approximately 3 weeks)
The Montreal Cognitive Assessment (MoCA) is a valid, 30-point screening tool used to assess "fibro fog"-the cognitive dysfunction, memory loss, and attention difficulties associated with fibromyalgia. Scoring: The test is scored out of 30 points. A score of 26-30 is considered normal, while scores below 26 may indicate mild cognitive impairment (19-25) or more advanced impairment (below 21). One point is added for individuals with 12 years or fewer of formal education.
次要结局
- Change in the brain's response to task stimuli(Baseline MRI and post-intervention MRI (approximately 3 weeks))
- Change in the brain's cortico-striatal circuit functional connectivity(Baseline MRI and post-intervention MRI (approximately 3 weeks))
- Ventral-dorsal spinal cord fMRI-indicated activity(Baseline MRI and post-intervention MRI (approximately 3 weeks))