[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07718906":3,"trial-entities:NCT07718906":103,"trial-summary:NCT07718906":109},{"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":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":36,"secondary_outcomes":41,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":51,"eligibility_criteria":52,"std_ages":64,"locations":67,"central_contacts":89,"overall_officials":97,"references":101,"see_also_links":102},"NCT07718906","RNI_NMD_EDR","Neuromodulation for Behavioral Changes in Neurological Disorders","A Prospective Early Feasibility Study of Focused Ultrasound Neuromodulation for Emotional Dysregulation Due to Dementia.","NOT_YET_RECRUITING","2028-12-30","2026-07","2026-07-22","2026-07-25","West Virginia University","OTHER",true,"The purpose of this study is to see if a focused ultrasound neuromodulation can be safely and effectively used to treat symptoms of emotional dysregulation such as agitation, irritability and anxiety","This open-label early feasibility study investigates low intensity focussed ultrasound (FUS), in participants with emotional dysregulation due to dementia. The primary objective is to test the safety and feasibility of FUS in this population.",[19],"Dementia",[21,22],"Neuromodulation","Focused Ultrasound","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},15,"ESTIMATED",[31],{"type":32,"name":22,"description":33,"armGroupLabels":34},"DEVICE","Subjects will undergo a single focused ultrasound Neuromodulation of the target brain region",[35],"Treatment",[37],{"measure":38,"description":39,"timeFrame":40},"Occurrence of Treatment Emergent Adverse Events","All adverse events that are related to FUS treatment will be assessed","Week 12 compared to baseline",[42,45],{"measure":43,"description":44,"timeFrame":40},"Change in behavioral symptoms","Change in behavioral symptoms as assessed by NPI",{"measure":46,"description":47,"timeFrame":40},"Changes in Anxiety symptoms","Changes in Anxiety symptoms as measured by GAD-7","ALL","45 Years","80 Years",false,{"inclusion":53,"exclusion":54,"raw_text":63},[],[55,56,57,58,59,60,61,62],"Moderate to severe dementia (i.e., beyond mild stage).","Clinically significant MRI abnormality that may jeopardize participant safety, study conduct, or confound diagnostic assessments.","History of clinically significant neurological disorder other than the qualifying dementia diagnosis that could confound evaluation or increase risk.","Major psychiatric disorder that would interfere with participation or safety, including psychosis, active suicidal ideation, or severe mood\u002Fanxiety disorder requiring immediate intervention.","Elevated suicide risk with History of medically verified suicide attempt within the past year.","Use of medications that significantly lower the seizure threshold or interfere with neuromodulation safety, as determined by the study physician.","Use of investigational drugs or participation in another interventional clinical trial within 30 days prior to screening.","Any condition that, in the opinion of the investigator, would interfere with study participation, safety, or interpretation of results.","* Age 45-80 years at time of enrollment.\n* Diagnosis of probable mild-stage neurodegenerative dementia, including Alzheimer's disease (AD), frontotemporal dementia (FTD, including behavioral variant and language variant), or dementia with Lewy bodies (LBD), based on established consensus clinical criteria.\n* Presence of clinically meaningful (in treatment for or recommended for the symptoms) neuropsychiatric or behavioral symptoms including but not limited to anxiety, agitation, depression, irritability, apathy, or disinhibition\n* Able to undergo MRI scanning\n* Adequate auditory and visual abilities to complete study procedures as determined by the investigator.\n* Availability of a study partner (legally authorized representative, caregiver, or family member) who has regular contact with the participant and can provide collateral information and assist with assessments.\n* Ability to provide informed consent, or assent with legally authorized representative (LAR) consent in accordance with WVU IRB policy and applicable West Virginia law. .Currently under the care of a licensed physician, psychiatrist, or neurologist, and agrees to allow communication between investigators\u002Fstudy staff and healthcare providers for purposes of eligibility confirmation and safety monitoring.\n\nEXCLUSION CRITERIA\n\n* Moderate to severe dementia (i.e., beyond mild stage).\n* Clinically significant MRI abnormality that may jeopardize participant safety, study conduct, or confound diagnostic assessments.\n* History of clinically significant neurological disorder other than the qualifying dementia diagnosis that could confound evaluation or increase risk.\n* Major psychiatric disorder that would interfere with participation or safety, including psychosis, active suicidal ideation, or severe mood\u002Fanxiety disorder requiring immediate intervention.\n* Elevated suicide risk with History of medically verified suicide attempt within the past year.\n* Use of medications that significantly lower the seizure threshold or interfere with neuromodulation safety, as determined by the study physician.\n* Use of investigational drugs or participation in another interventional clinical trial within 30 days prior to screening.\n* Any condition that, in the opinion of the investigator, would interfere with study participation, safety, or interpretation of results.",[65,66],"ADULT","OLDER_ADULT",[68],{"facility":69,"city":70,"state":71,"zip":72,"country":73,"contacts":74,"geoPoint":86},"WVU Rockefeller Neuroscience Institute","Morgantown","West Virginia","26505","United States",[75,80,83],{"name":76,"role":77,"phone":78,"email":79},"Victor Finomore, PhD","CONTACT","3042760500","vfinomore@hsc.wvu.edu",{"name":81,"role":77,"phone":78,"email":82},"Padma Tirumalai, PhD","ptirumalai@hsc.wvu.edu",{"name":84,"role":85},"Marc Haut, PhD","SUB_INVESTIGATOR",{"lat":87,"lon":88},39.62953,-79.9559,[90,93],{"name":84,"role":77,"phone":91,"email":92},"304-293-8182","mhaut@hsc.wvu.edu",{"name":94,"role":77,"phone":95,"email":96},"Jennifer Marton, BA","304-293-5886","jmarton@hsc.wvu.edu",[98],{"name":99,"affiliation":69,"role":100},"Ali Rezai","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":104,"biomarkers":108},[105,106,107],"Alzheimer's Disease","Frontotemporal Dementia","Lewy Body Dementia",[],{"nct_id":4,"found":15,"summary":110,"prompt_version":120},{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This is an open-label study, meaning both you and the study team will know you are receiving the Focused Ultrasound treatment. It is an early feasibility study and plans to enroll 15 participants.","completed","Focused Ultrasound for Behavioral Changes in Dementia","This study is testing a treatment called Focused Ultrasound (FUS) to see if it can safely and effectively help with emotional problems like agitation, irritability, and anxiety in people with dementia. FUS is a device that uses sound waves to target specific areas of the brain. You may be able to join if you are between 45 and 80 years old and have a diagnosis of mild-stage neurodegenerative dementia, such as Alzheimer's disease, frontotemporal dementia, or Lewy body dementia. The main goal of this study is to see if FUS is safe and practical for this group of patients. The current recruitment status is unclear, and the study plans to enroll 15 participants.","You will be followed for 12 weeks after the Focused Ultrasound treatment to monitor for any adverse events.",113,"You will undergo a single Focused Ultrasound neuromodulation treatment to a specific brain region. The study will then monitor for any side effects for 12 weeks after the treatment.","Not stated in the trial record.",[22],"v2"]