[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589375":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":31,"responsibleParty":50,"collaborators":11,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":11,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":11,"enrollmentInfo":62,"targetDuration":11,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":79,"whyStopped":11,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Bruyère Health Research Institute.","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"rTMS Intervention","EXPERIMENTAL",null,[13],"Device: Repetitive Transcranial Magnetic Stimulation (rTMS)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","Repetitive Transcranial Magnetic Stimulation (rTMS)","Eight rTMS sessions will be administer per day at 60-minute intervals for 5 consecutive days.\n\nEach rTMS session will consist of 600 pulses of theta-burst stimulation (iTBS), a pattern of 3 TMS pulses every 200 milliseconds for 2 seconds (i.e., 3 x 50 Hz bursts repeated at 5 Hz) for 3 minutes at 100% of resting motor threshold. The left dorsomedial prefrontal cortex (DMPFC) will be targeted via the Fz EEG site (30% of the nasion-inion distance posteriorly along the nasion-inion line).",[9],[21,27],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},"James Downar, MDCM, MHSc","CONTACT","613-562-6262","1502","jdownar@toh.ca",{"name":28,"role":23,"phone":24,"phoneExt":29,"email":30},"Nadia Polskaia, PhD","2352","npolskaia@bruyere.org",[32],{"facility":33,"status":11,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Bruyere Health","Ottawa","Ontario","K1R 7A5","Canada","CA",{"type":40,"coordinates":41},"Point",[42,43],-75.69812,45.41117,{"lat":43,"lon":42},[46,47,48],{"name":28,"role":23,"phone":24,"phoneExt":29,"email":30},{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},{"name":22,"role":49,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":49,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"James Downar","Head, Division of Palliative Care, University of Ottawa","100589375","transcranial-magnetic-stimulation-to-treat-prolonged-grief-disorder-100589375",false,"NCT06953596","Transcranial Magnetic Stimulation to Treat Prolonged Grief Disorder","Transcranial Magnetic Stimulation to Treat Prolonged Grief Disorder: A Single-centre, Single-arm, Open-label Phase I\u002FII Proof-of-concept and Feasibility Clinical Trial","Inclusion Criteria:\n\n1. Bereaved individuals \\>\u002F= 18 years of age\n2. Score \\>25 on the Inventory of Complicated Grief\n3. Must have a primary care physician\n4. Ability to understand and communicate in English\n5. Ability to provide first-person informed consent\n\nExclusion Criteria:\n\n1. Current or previously diagnosed seizure disorder\n2. Documented brain lesions\n3. Contraindications to TMS (i.e., metallic skull plates, clips, stimulators, pacemakers)\n4. Current substance abuse disorder (e.g., schizophrenia)\n5. Pregnancy or lactation, or trying to conceive\n6. Advanced, incurable illness with an expected prognosis of \\\u003C3 months - bereaved family members are known to be at elevated risk of death from medical illness, but if death is expected in the near future, it would be difficult to justify using an entire week of their limited time for an unproven therapy.","ALL","18 Years",{"count":63,"type":64},15,"ESTIMATED","INTERVENTIONAL",[67],"NA","Grief is a normal response after the death of a loved one. With time, the grief response decreases and people learn to cope with their loss. However, for some, the response becomes more intense and distressing. This is called prolonged grief disorder (PGD). People with PGD experience emotional pain and a deep longing for their loved one. PGD normally occurs \\\u003C10% of people after a loss, but it has become more common since the COVID-19 pandemic (\\~30%). If left untreated, PGD leads to poor quality of life and increased risk of death. Treatment options such as medication and therapy are available; however, they can cause negative side effects and take a long time to work. To help individuals with PGD, we need treatments that work well and quickly.\n\nRepetitive transcranial magnetic stimulation (rTMS) is a safe, non-invasive treatment that delivers magnetic pulses to brain areas responsible for mood. rTMS has been approved in Canada to treat mood disorders. There is research to show that rTMS is safe and well-tolerated, and that works well in treating Post-Traumatic Stress Disorder (PTSD), a condition with similar symptoms to PGD. To determine whether rTMS is effective for treating PGD, we first need to determine if rTMS as a treatment for PGD is safe and feasible among grieving individuals.",[70,71],"Prolonged Grief Disorder","Complicated Grief",[73,74,75,76,77,78],"Neuromodulation","Repetitive Transcranial Magnetic Stimulation","Bereavement","Proof-of-Concept","Feasibility","Intermittent Theta Burst Stimulation (iTBS)","NOT_YET_RECRUITING","2025-04-29",{"date":82,"type":83},"2025-05-01","ACTUAL",{"date":85,"type":64},"2025-07-01",{"date":87,"type":64},"2026-04-30",{"name":5,"class":6},1]