[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580283":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":18,"centralContacts":19,"locations":25,"responsibleParty":43,"collaborators":18,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":18,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":18,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":28,"whyStopped":18,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Baylor College of Medicine","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Brain Stimulation","Participants will receive a combination of two non-invasive brain stimulation treatments. During the first week, iTBS sessions will be administered in-clinic for five consecutive days, using magnetic pulses to target brain areas associated with neuropsychiatric symptoms. This is followed by four weeks of daily, self-administered tDCS at home, delivering a low electrical current to modulate brain activity. Participants will complete brain scans and questionnaires at various points to evaluate changes in the brain and symptom severity.",[12],"Device: Brain Stimulation",[14],{"type":15,"name":9,"description":16,"armGroupLabels":17,"otherNames":18},"DEVICE","This intervention is distinct because it combines two non-invasive brain stimulation techniques, intermittent theta burst stimulation (iTBS) and transcranial direct current stimulation (tDCS), in a sequential manner. Unlike studies that evaluate these techniques individually, this study explores their combined and complementary effects, with iTBS priming the brain to enhance the subsequent impact of tDCS. The sequential design leverages different mechanisms of action: iTBS delivers magnetic pulses to targeted brain areas to modulate neural activity, while tDCS applies a low electrical current for sustained modulation. This approach specifically targets neuropsychiatric symptoms (e.g., mood swings, apathy, and agitation) in individuals with Alzheimer's Disease and related dementias (ADRD), a population often underserved by traditional interventions. The study also evaluates the feasibility of at-home tDCS administration, making it unique in combining clinical and caregiver-managed treat",[9],null,[20],{"name":21,"role":22,"phone":23,"phoneExt":18,"email":24},"Lane Witkowski Research Coordinator","CONTACT","206-419-1261","Lane.Witkowski@va.gov",[26],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Michael E. DeBakey VA Medical Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-95.36327,29.76328,{"lat":38,"lon":37},[41],{"name":42,"role":22,"phone":23,"phoneExt":18,"email":18},"Lane Witkowski",{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Ricardo Jorge, MD","Psychiatrist","100580283","novel-brain-stimulation-treatment-for-neuropsychiatric-symptoms-in-alzheimers-disease-100580283",false,"NCT06835283","Novel Brain Stimulation Treatment for Neuropsychiatric Symptoms in Alzheimer's Disease","Sequential Accelerated ITBS \u002F Remote tDCS for Treatment of Neuropsychiatric Symptoms in Alzheimer's Disease: A Pilot Study","Inclusion criteria\n\n1. veteran between the ages of 60 to 85\n2. clinical diagnosis of mild to moderate Alzheimer's disease or related dementia\n3. clinically significant neuropsychiatric symptoms (NPS) evidenced by a score ≥ 2 in at least one domain of the Neuropsychiatric Inventory Questionnaire\n4. mild to moderate cognitive impairment demonstrated by a Mini-Mental State Examination (MMSE) score of 15-23\n5. have a caregiver who is able and willing to escort the patient to\u002Ffrom clinic visits, answer questionnaires, and assist in the implementation of treatment sessions at home\n6. if taking psychotropic medications, demonstrate stability for at least 4 weeks of treatment\n\nExclusion Criteria:\n\n1. any contraindication for MRI\n2. any contraindication for iTBS\u002FtDCS including but not limited to seizure disorder, severe cardiovascular disease, history of brain surgery, or stroke involving the cerebral cortex near area of stimulation\n3. current alcohol or substance use disorder determined by QuickSCID (nicotine allowed; mild cannabis and alcohol use is allowed)\n4. neuropsychiatric symptoms (NPS) that are severe enough to preclude the intervention from being delivered safely and effectively, particularly agitation or aggression.\n\n6\\) any unstable coexisting medical condition that in the opinion of the principal investigator(s) interferes with the treatment protocol or increase the likelihood of adverse events.","ALL","65 Years","85 Years",{"count":58,"type":59},20,"ESTIMATED","INTERVENTIONAL",[62],"NA","The goal of this pilot study is to test a combination of two non-invasive brain stimulation methods, called iTBS (intermittent theta burst stimulation) and tDCS (transcranial direct current stimulation), in people with Alzheimer's Disease (AD) and related dementias (ADRD). This study will also explore whether the combined treatment shows promise for reducing neuropsychiatric symptoms like mood swings, apathy, and agitation, and will evaluate the impact of the treatment on caregivers.\n\nThe main questions the study aims to answer are:\n\n1. Is the combined brain stimulation treatment practical and well-tolerated?\n2. Do preliminary results suggest that this treatment could help manage neuropsychiatric symptoms and support a larger study?\n\nParticipants will:\n\n* Attend nine in-person visits over three months.\n* Complete one week of in-clinic brain stimulation sessions (iTBS) followed by four weeks of daily at-home brain stimulation sessions (tDCS).\n* Take part in brain scans, questionnaires, and brain activity tests before and after the treatment.\n\nThis pilot study is a first step to assess whether this combined treatment approach is practical and whether it has potential to improve symptoms, laying the groundwork for larger studies in the future.",[65,66,67],"Alzheimer&Amp;#39;s Disease-related Dementia","Alzheimer Disease","rTMS Stimulation",[69,70,71,72,73],"Alzheimer's Disease","tDCS","iTBS","brain stimulation","mood swings","2026-05-05",{"date":76,"type":77},"2026-05-07","ACTUAL",{"date":79,"type":59},"2026-08-01",{"date":81,"type":59},"2027-08",{"name":5,"class":6},1]