[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605134":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":45,"locations":55,"responsibleParty":90,"collaborators":49,"id":92,"slug":49,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":49,"enrollmentInfo":101,"targetDuration":49,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":119,"whyStopped":49,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"active-iTBS+yoga","EXPERIMENTAL","real or active intermittent theta burst stimulation provided prior to participation in small group LoveYourBrain Yoga program class",[13,14],"Device: intermittent theta burst stimulation","Behavioral: LoveYourBrain Yoga Program",{"label":16,"type":17,"description":18,"interventionNames":19},"sham-iTBS+yoga","PLACEBO_COMPARATOR","fake, inactive or sham intermittent theta burst stimulation (designed to look, sound and feel like real or active stimulation) provided prior to participation in small group LoveYourBrain Yoga program class",[13,14],{"label":21,"type":22,"description":23,"interventionNames":24},"active-iTBS alone","ACTIVE_COMPARATOR","real or active intermittent theta burst stimulation alone (no yoga participation)",[13],[26,33],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","intermittent theta burst stimulation","Transcranial magnetic stimulation (TMS) is a non-invasive neuromodulatory treatment. TMS has been FDA cleared since 2008 for treatment resistant depression. It is now FDA cleared for a few other indications including migraine. Magnetic pulses are delivered through a coil placed on the scalp and when the magnetic field reaches brain cells, it changes to an electric current that can increase or decrease excitability depending on the treatment parameters. Intermittent theta burst stimulation (iTBS) is a type of patterned, excitatory TMS. iTBS only takes 3 minutes to deliver and is theorized to induce a window of neuroplasticity that lasts at least 1 hour. The Magventure with Magoption x100 Stimulator and associated coil the investigators are using can be set to deliver active (real) or sham (fake or inactive) TMS. The sham device is designed to look, sound and feel like real TMS.",[21,9,16],[32],"transcranial magnetic stimulation (TMS), Magventure",{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"BEHAVIORAL","LoveYourBrain Yoga Program","This yoga program is evidence-based, standardized and manualized. It is developed by the LoveYourBrain Foundation (www.loveyourbrain.com). Each yoga session includes 10 min of breathing exercises, 45 min of gentle yoga or stretching exercises, 15 min of guided meditation, and 20 min of facilitated discussion with psychoeducation, detailed in a manual to ensure standardization of program content across time and instructors.",[9,16],[39],"yoga, hatha-based yoga",[41],{"name":42,"affiliation":43,"role":44},"Amy A Herrold, PhD BA","Edward Hines Jr. VA Hospital, Hines, IL","PRINCIPAL_INVESTIGATOR",[46,51],{"name":42,"role":47,"phone":48,"phoneExt":49,"email":50},"CONTACT","(708) 202-5867",null,"amy.herrold@va.gov",{"name":52,"role":47,"phone":53,"phoneExt":49,"email":54},"Ibuola Kale, MPH BS","(708) 202-5898","Ibuola.Kale@va.gov",[56,73],{"facility":57,"status":49,"city":58,"state":59,"zip":60,"country":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Jesse Brown VA Medical Center, Chicago, IL","Chicago","Illinois","60612","United States",{"type":63,"coordinates":64},"Point",[65,66],-87.65005,41.85003,{"lat":66,"lon":65},[69],{"name":70,"role":47,"phone":71,"phoneExt":49,"email":72},"Howard S Gordon, MD","312-569-7331","howard.gordon2@va.gov",{"facility":43,"status":49,"city":74,"state":59,"zip":75,"country":61,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Hines","60141-3030",{"type":63,"coordinates":77},[78,79],-87.8395,41.85364,{"lat":79,"lon":78},[82,85,89],{"name":83,"role":47,"phone":49,"phoneExt":49,"email":84},"Gabriella G Amador","Gabriella.Amador@va.gov",{"name":86,"role":47,"phone":87,"phoneExt":49,"email":88},"William Wolf, PhD","(708) 202-5689","William.Wolf@va.gov",{"name":42,"role":44,"phone":49,"phoneExt":49,"email":49},{"type":91,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100605134",false,"NCT07158567","Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT","Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low Back PaiN Treatment: VIBRANT","VIBRANT","Inclusion Criteria:\n\n* 1 mo. stability in pain management strategies.\n* 22+ years of age.\n* Can read and speak English.\n* Able to participate in strengthening, stretching, range of motion exercise via yoga as determined by study physician.\n* Chronic Low Back Pain (CLBP): pain in the low back that persists for \\>6 months and is of moderate to severe intensity with a score of \\>5 on specific items on the BPI demonstrating disability of at least 20% on the Oswestry Disability Index (ODI).\n\nExclusion Criteria:\n\n* Contraindications to iTBS\u002FTMS (e.g. epilepsy, psychotic spectrum disorders \\[i.e. bipolar, schizophrenia\\], history of anoxic brain injury).\n* Moderate to severe heart disease.\n* Contraindications to MRI (e.g., claustrophobia, implanted ferromagnetic device such as pacemaker or cardiac defibrillator).\n* Pain believed to be associated with cardiac or ischemic conditions.\n* Epilepsy, active seizure disorder, personal history of a seizure or individuals with a family history of epilepsy or seizure in a first degree relative.\n* Current prescription of psychostimulants (e.g., amphetamines), anticholinergics, tricyclic antidepressants, and antipsychotics or other medications that may increase their risk of having seizures.\n* Intracranial lesion.\n* History of ischemic or hemorrhagic stroke.\n* History of moderate to severe TBI.\n* History of or current psychosis not due to an external cause (e.g., due to illicit drug use).\n* Other neurological conditions (e.g., neurodegenerative disorders).\n* Active suicidal ideation with Columbia Suicide Severity Rating Scale(CSSRS) 3 .\n* Are pregnant or nursing.\n* Within 12 weeks of a major surgery\u002Foperation.","ALL","22 Years",{"count":102,"type":103},213,"ESTIMATED","INTERVENTIONAL",[106],"PHASE3","The objectives of this VA Merit application are to demonstrate efficacy of combined intermittent theta burst (iTBS) and yoga (iTBS+yoga) intervention on improving pain, function, analgesic use, self-efficacy, quality of life and well-being among Veterans with chronic low back pain (CLBP). This Merit project will directly benefit Veterans and VA Services by demonstrating efficacy of a new, non-medication treatment for Veterans with CLBP in need of non-opioid treatment options. Neuromodulation including iTBS is now offered at over 50 VA hospitals and yoga is among the complementary and integrative health programs being rolled out as a part of VAs Whole Health implementation efforts. Thus, should iTBS+yoga ultimately prove to be efficacious, VA facilities will be well-poised to offer this treatment. A novel, activity-based, non-medication treatment for Veterans with CLBP is of great need given the high prevalence of CLBP.",[109,110],"Chronic Low Back Pain","Musculoskeletal Pain",[112,113,114,115,116,117,118],"chronic low back pain","transcranial magnetic stimulation","TMS","neuromodulation","yoga","complementary and integrative health","musculoskeletal pain","NOT_YET_RECRUITING","2026-06-03",{"date":122,"type":123},"2026-06-05","ACTUAL",{"date":125,"type":103},"2026-07-01",{"date":127,"type":103},"2031-12-31",{"name":5,"class":6},2]