[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07525063":3,"trial-entities:NCT07525063":96,"trial-summary:NCT07525063":99},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":31,"primary_purpose":32,"phases":33,"enrollment_info":35,"interventions":38,"primary_outcomes":45,"secondary_outcomes":56,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":14,"eligibility_criteria":69,"std_ages":73,"locations":76,"central_contacts":86,"overall_officials":87,"references":91,"see_also_links":92},"NCT07525063","Pro00118676","Pain & Reward Neuromodulation of CNS Circuits","ENROLLING_BY_INVITATION","2027-06","2026-07","2026-07-28","2026-07-21","Duke University","OTHER",false,"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.","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.\n\nFemale 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.\n\nDuring each of 2 MRI study visits, participants will:\n\n* Have a urine test for drug use (and pregnancy if applicable)\n* Have a blood draw to measure inflammation and\u002For genetic testing\n* Have magnetic resonance imaging (MRI) scans of the brain and spine\n* Complete behavior tests (participate in games or tasks), sensory tests, and questionnaires\n\nDuring each of 4 TMS study visits, participants will:\n\n* Have brief transcranial magnetic stimulation (TMS) applied to the head\n* Complete behavior tests (participate in games or tasks), sensory tests, and questionnaires\n\nParticipation is complete once the requested study visits and follow-up questionnaires have been completed.",[18,19,20],"Fibromyalgia Syndrome","Fibromyalgia","Chronic Pain and Fatigue",[19,22,23,24,25,26,27,28,29,18,30],"Transcranial Magnetic Stimulation","Neuromodulation","fatigue","cognitive issues","fibro fog","brain fog","trouble sleeping","AFSA","pain","INTERVENTIONAL","TREATMENT",[34],"NA",{"count":36,"type":37},30,"ESTIMATED",[39],{"type":40,"name":41,"description":42,"armGroupLabels":43},"DEVICE","Transcranial Magnetic Stimulation (TMS)","TMS protocol delivered via MagPro X100 stimulator with figure-8 coil targeting prefrontal cortex.",[44],"Active TMS",[46,50,53],{"measure":47,"description":48,"timeFrame":49},"Change in Pain Intensity","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).","Baseline MRI and post-intervention MRI (approximately 3 weeks)",{"measure":51,"description":52,"timeFrame":49},"Change in Fatigue","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.",{"measure":54,"description":55,"timeFrame":49},"Change in FMS-related brain\u002Ffibro fog as measured by the Montreal Cognitive Assessment (MoCA)","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.",[57,60,63],{"measure":58,"description":59,"timeFrame":49},"Change in the brain's response to task stimuli","Functional Magnetic Resonance Imaging (fMRI) will be used to track blood-oxygen-level-dependent (BOLD) signals during reward anticipation and feedback. BOLD signal change identifies neural activity in the brain which will be reported as normalized to percent signal change (Avg%Δ) relative to the mean image intensity to allow for cross-subject comparison (i.e., arbitrary units scale).",{"measure":61,"description":62,"timeFrame":49},"Change in the brain's cortico-striatal circuit functional connectivity","Functional connectivity in fMRI measures the statistical dependencies (similarities) between blood oxygen level-dependent (BOLD) signal time series from different brain regions. Typically quantified using Pearson's correlation or covariance in either resting-state or task-based studies, it identifies synchronized activity indicating functionally linked regions\u002Fnetworks.",{"measure":64,"description":65,"timeFrame":49},"Ventral-dorsal spinal cord fMRI-indicated activity","Amplitude of Low-Frequency Fluctuations (ALFF) in fMRI measures the intensity of spontaneous brain activity by calculating the square root of the power spectrum (via Fast Fourier Transform) within a specific low-frequency range. It quantifies the amplitude of resting-state BOLD signal oscillations, typically after voxel-wise standardization (i.e., arbitrary units scale).","FEMALE","18 Years",null,{"inclusion":70,"exclusion":71,"raw_text":72},[],[],"Inclusions:\n\n1. Female and ages 18 +\n2. Ability to read\u002Funderstand English and give consent to participate\n3. Physician diagnosis \\& confirmation of primary fibromyalgia syndrome\n4. 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\n5. If enrolled in psychotherapy, verbal agreement to maintain (not change or stop) the psychotherapy during the study\n6. Absence of use of opioid medications (during the previous 90 days, and no greater than a 30-day period during lifetime)\n\nExclusions:\n\n1. limited ability to participate fully in behavioral tasks, longitudinal follow-up (e.g., plans to move out-of-state within 3 months)\n2. MRI contraindication (e.g., metal implants, claustrophobia, pregnant or planning to become pregnant)\n3. 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\u002Fneck injury, use of certain medications)\n4. male \\*\n\nTMS-Specific Exclusions:\n\n1\\. TMS contraindication (e.g., history of seizures, medications contraindicated for risks\u002Fefficacy of TMS procedures)\n\n1. current hypomania,\n2. meets diagnostic criteria for current psychotic disorder, or psychotic features,\n3. meets diagnostic criteria for Bipolar I disorder,\n4. meets diagnostic criteria for current alcohol or substance use disorder (moderate and high severity)\n5. current uncontrolled anorexia or other condition requiring hospitalization,\n6. current serious medical illness, including current severe migraine headaches,\n7. changed psychotropic medications in the prior 2 months, or plans to change medication during the study,\n8. 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),\n9. conditions associated with increased intracranial pressure, space occupying brain lesion, transient ischemic attack, cerebral aneurysm, dementia, Parkinson's or Huntington's disease, multiple sclerosis,\n10. use of investigational drug or devices within 4 weeks of screening,\n11. cochlear implants,\n12. pregnancy\n\n    * 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.\n\nDue 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",[74,75],"ADULT","OLDER_ADULT",[77],{"facility":78,"city":79,"state":80,"zip":81,"country":82,"geoPoint":83},"Duke University Medical Center","Durham","North Carolina","27710","United States",{"lat":84,"lon":85},35.99403,-78.89862,[],[88],{"name":89,"affiliation":12,"role":90},"Katherine T Martucci, PhD","PRINCIPAL_INVESTIGATOR",[],[93],{"label":94,"url":95},"Martucci Lab Website","https:\u002F\u002Fanesthesiology.duke.edu\u002Fresearch\u002Fmartucci-lab",{"nct_id":4,"conditions":97,"biomarkers":98},[19],[],{"nct_id":4,"found":100,"summary":101,"prompt_version":111},true,{"design":102,"status":103,"heading":104,"summary":105,"follow_up":106,"word_count":107,"commitments":108,"compensation":109,"drugs_mentioned":110},"This is an interventional study with a planned enrollment of 30 female participants. It is a pilot study to compare brain activity before and after the intervention.","completed","Transcranial Magnetic Stimulation for Fibromyalgia Pain and Fatigue","This study is testing a device called Transcranial Magnetic Stimulation (TMS) to see if it can help women with fibromyalgia syndrome (FMS). TMS uses magnetic pulses to target a specific area of the brain (prefrontal cortex). Researchers want to see if TMS can reduce pain and fatigue, and improve \"fibro fog\" (brain fog) in people with FMS. They will measure these changes using MRI scans and questionnaires before and after the TMS treatments. The study is looking for 30 female participants who have been diagnosed with fibromyalgia. The current recruitment status is unclear.","You will be followed for six months after the intervention with remote questionnaires.",93,"You would visit Duke Hospital up to 6 times, including MRI scans and 4 days of TMS sessions. There will also be remote follow-up questionnaires at one, three, and six months.","Not stated in the trial record.",[41],"v2"]