[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07644221":3,"trial-entities:NCT07644221":138,"trial-summary:NCT07644221":141},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":46,"secondary_outcomes":62,"sex":75,"minimum_age":76,"maximum_age":77,"healthy_volunteers":14,"eligibility_criteria":78,"std_ages":92,"locations":95,"central_contacts":127,"overall_officials":131,"references":136,"see_also_links":137},"NCT07644221","STUDY2025_00000279","Feasibility and Effects of Noninvasive Brain Stimulation on Pain Perception in People With Fibromyalgia","Transcranial Electrical Stimulation for Noninvasive Study of Pain Circuits in Patients With Chronic Pain","NOT_YET_RECRUITING","2027-12","2026-06","2026-06-12","Pulkit Grover","OTHER",false,"The goal of this interventional study is to learn whether noninvasive brain stimulation (NIBS) will have an effect on pain perception in people with fibromyalgia. The main questions it aims to answer are:\n\nDo repeated sessions of NIBS lead to a reduction in perceived pain? Do repeated sessions of NIBS lead to an improvement in quality of life?\n\nResearchers will compare different brain targets to see if effects are different between them.\n\nParticipants will receive repeated daily sessions of NIBS over 4 weeks with application of pressure pain algometry, and complete various questionnaires.","Participants will randomly receive primary motor cortex (M1) or occipital lobe NIBS over 2 weeks, and after a wash-out period will receive NIBS of the other target over 2 weeks. Each session will also evaluate pressure pain algometry, various questionnaires to assess changes in fibromyalgia symptoms and quality of life (up to 5 hours per session)\n\nNIBS administration will consist of 1000 electrical pulses of \\\u003C1 ms duration each.",[18],"Fibromyalgia (FM)",[20,21,22,23,24],"Transcranial Electrical Stimulation","Noninvasive Brain Stimulation","Fibromyalgia","Chronic Pain","Pulsed Transcranial Electrical Stimulation","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},50,"ESTIMATED",[33,41],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":40},"DEVICE","Primary Motor Cortex Stimulation","Short (\\\u003C1 ms), high amplitude (\\>10 mA) noninvasive electrical pulses delivered at 1 Hz on the scalp surface. This intervention will target the primary motor cortex (M1).",[38,39],"Occipital Lobe Stimulation, then Primary Motor Cortex Stimulation","Primary Motor Cortex Stimulation, then Occipital Lobe Stimulation",[20],{"type":34,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Occipital Lobe Stimulation","Short (\\\u003C1 ms), high amplitude (\\>10 mA) noninvasive electrical pulses delivered at 1 Hz on the scalp surface. This intervention will target the occipital lobe.",[38,39],[20],[47,51,55,58],{"measure":48,"description":49,"timeFrame":50},"Feasibility of the transcranial electrical stimulation protocol","Feasibility of the protocol will be measured quantitatively using the Feasibility of Intervention Measure (FIM) score. Score ranges from 4 to 20, with higher scores indicating higher level of feasibility. It will also be assessed qualitatively via participant interviews.","From end of the last study session until up to 6 months after.",{"measure":52,"description":53,"timeFrame":54},"Tolerability of transcranial electrical stimulation protocol","Determined qualitatively from study-related participant attrition rate (%) and adherence to protocol (%).","Every day from enrollment until up to 6 months after the last study session.",{"measure":56,"description":57,"timeFrame":50},"Acceptability of transcranial electrical stimulation protocol","Acceptability of the protocol will be measured quantitatively using the Acceptability of Intervention Measure (AIM) score. Score ranges from 4 to 20, with higher scores indicating higher level of acceptability. It will also be assessed qualitatively via participant interviews.",{"measure":59,"description":60,"timeFrame":61},"Pressure pain threshold (PPT)","PPT (in lbf) will be measured using a digital algometer, which will be used to press down on the participants' thumb nails and legs to assess pain sensitization throughout the study.","At every study session from Session 1 until the last study session.",[63,67,71],{"measure":64,"description":65,"timeFrame":66},"Revised Fibromyalgia Impact Questionnaire (FIQR)","FIQR will be used to assess the participant's experience with fibromyalgia (symptoms and impact on daily life). Score ranges from 0 to 100, with higher scores indicating greater severity of fibromyalgia symptoms and functional impairment.","Weekly from enrollment until up to 6 months after the last study session.",{"measure":68,"description":69,"timeFrame":70},"Brief Pain Inventory (BPI)","BPI will be used to assess the participant's pain severity and interference. Score ranges from 0 to 10, with higher scores indicating worse (more severe) pain or interference.","Daily, from enrollment until up to 6 months after the last study session.",{"measure":72,"description":73,"timeFrame":74},"Patient-Reported Outcomes Measurement Information System (PROMIS-29)","We will use the standardized survey score PROMIS-29 to assess physical and mental health in seven domains (e.g., physical function, anxiety, sleep disturbance etc.). Each question score ranges from one to five, corresponding to the intensity within the question's domain. Survey scores will be converted to a t-score metric and assessed.","Weekly, from enrollment until up to 6 months after the last study session.","ALL","18 Years","65 Years",{"inclusion":79,"exclusion":84,"raw_text":91},[80,81,82,83],"Formal diagnosis of fibromyalgia made by a practicing physician","Pain resistant to common analgesics and medications for chronic pain","Existing pain for more than 3 months with an average of at least 4 on a 0 to 10 Numerical Rating Scale (NRS)","Females of child bearing potential must be at least one of the following totally abstinent from heterosexual intercourse since the last menses before start of study, or agree to concurrent use of at least two methods of birth control throughout study participation.",[85,86,87,88,89,90],"If the subject is non-ambulatory.","If the subject is female of child-bearing potential, subject must not be pregnant.","Subject must not have a history of brain surgery or uncontrolled neurological conditions, such as seizure, fainting spells, transient ischemic attack.","Subject must not have lifetime history of severe, uncontrolled mood disorders (anxiety, depression, bipolar), psychotic disorders, other neural disorders, or heart disease.","Subject must not have any implanted electronic or metallic devices.","Subject must not have heart diseases, including known arrhythmia, or severe liver or severe gastrointestinal disease or chronic severe infectious disease (e.g. HIV\u002FAIDS).","Inclusion Criteria:\n\n* Formal diagnosis of fibromyalgia made by a practicing physician\n* Pain resistant to common analgesics and medications for chronic pain\n* Existing pain for more than 3 months with an average of at least 4 on a 0 to 10 Numerical Rating Scale (NRS)\n* Females of child bearing potential must be at least one of the following totally abstinent from heterosexual intercourse since the last menses before start of study, or agree to concurrent use of at least two methods of birth control throughout study participation.\n\nExclusion Criteria:\n\n* If the subject is non-ambulatory.\n* If the subject is female of child-bearing potential, subject must not be pregnant.\n* Subject must not have a history of brain surgery or uncontrolled neurological conditions, such as seizure, fainting spells, transient ischemic attack.\n* Subject must not have lifetime history of severe, uncontrolled mood disorders (anxiety, depression, bipolar), psychotic disorders, other neural disorders, or heart disease.\n* Subject must not have any implanted electronic or metallic devices.\n* Subject must not have heart diseases, including known arrhythmia, or severe liver or severe gastrointestinal disease or chronic severe infectious disease (e.g. HIV\u002FAIDS).",[93,94],"ADULT","OLDER_ADULT",[96,114],{"facility":97,"city":98,"state":99,"zip":100,"country":101,"contacts":102,"geoPoint":111},"UPMC Pain Management","Pittsburgh","Pennsylvania","15206","United States",[103,108],{"name":104,"role":105,"phone":106,"email":107},"Benedict J Alter, MD, PhD","CONTACT","412-677-0575","alterbj@upmc.edu",{"name":109,"role":105,"email":110},"Emma Racunas, BS","ECR79@pitt.edu",{"lat":112,"lon":113},40.44062,-79.99589,{"facility":115,"city":98,"state":99,"zip":116,"country":101,"contacts":117,"geoPoint":126},"Carnegie Mellon University","15213",[118,122],{"name":119,"role":105,"phone":120,"email":121},"Pulkit Grover, PhD","412-268-3644","pgrover@andrew.cmu.edu",{"name":123,"role":105,"phone":124,"email":125},"Jeehyun Kim, MS","248-619-4271","jeehyunk@andrew.cmu.edu",{"lat":112,"lon":113},[128,129],{"name":119,"role":105,"phone":120,"email":121},{"name":130,"role":105,"phone":106,"email":107},"Benedict J Alter, PhD",[132,134],{"name":119,"affiliation":115,"role":133},"PRINCIPAL_INVESTIGATOR",{"name":104,"affiliation":135,"role":133},"University of Pittsburgh",[],[],{"nct_id":4,"conditions":139,"biomarkers":140},[22],[],{"nct_id":4,"found":14,"summary":142,"prompt_version":142},null]