[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06453980":3,"trial-entities:NCT06453980":113,"trial-summary:NCT06453980":118},{"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":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":47,"secondary_outcomes":56,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":79,"locations":82,"central_contacts":99,"overall_officials":108,"references":111,"see_also_links":112},"NCT06453980","HUM00201483","Multimodal Investigation of Neural Plasticity","Multimodal Investigation of Neural Plasticity Induced by Non-invasive Brain Stimulation","RECRUITING","2026-04-30","2026-03","2026-03-10","2024-05-13","University of Michigan","OTHER",false,"This study will evaluate the effects of a form of non-invasive brain stimulation on brain functioning and memory in cognitively intact older adults (healthy controls, HC) and in those with mild cognitive impairment (MCI).","The goal of this study is to learn important information about the effects of weak electrical stimulation (known as high-definition transcranial direct current stimulation or HD-tDCS) on brain functioning in those with mild cognitive impairment (MCI). The findings will help determine how stimulation affects brain's activity and metabolism (in particular, the neurotransmitter glutamate). Ultimately, this information may help develop new treatments for those with Alzheimer's disease. The study will use different forms of brain imaging to see whether stimulation changes how the brain responds during a memory task. Functional magnetic resonance spectroscopy (fMRS), functional magnetic resonance imaging (fMRI), and functional near-infrared spectroscopy (fNIRS) will be used. The study also uses cognitive tests and questionnaires.",[19],"Mild Cognitive Impairment",[21,22,23,24,25],"tDCS","Glutamate","MRS","fMRI","fNIRS","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},80,"ESTIMATED",[34,41],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DEVICE","sham tDCS","Participants will receive sham (placebo) HD-tDCS for 20 minutes, for 1 session.",[39,40],"HC sham tDCS","MCI sham tDCS",{"type":35,"name":42,"description":43,"armGroupLabels":44},"active tDCS","Participants will receive HD-tDCS at 3 milliAmp for 20 minutes, for 1 session.",[45,46],"HC active tDCS","MCI active tDCS",[48,52],{"measure":49,"description":50,"timeFrame":51},"Changes in glutamate concentration (fMRS)","Analyses via fMRS using units of concentration","average on 1 week",{"measure":53,"description":54,"timeFrame":55},"Changes in brain activation (fMRI)","Analyses via fMRI using units of brain activation","average of 1 week",[57,60],{"measure":58,"description":59,"timeFrame":55},"Changes in memory performance","Analyses of memory performance indexed as percent accuracy",{"measure":61,"description":62,"timeFrame":63},"Changes in brain activation (fNIRS)","Analyses via fNIRS using units of brain activation","immediate, concurrent with tDCS","ALL","60 Years",null,true,{"inclusion":69,"exclusion":73,"raw_text":78},[70,71,72],"Normal cognition for HC and diagnosis of Mild Cognitive Impairment (MCI) for MCI participants","Right-handedness","Magnetic resonance compatible, criteria that also apply for high definition transcranial direct current stimulation (HD-tDCS; e.g., absence of metallic or electronic implants in the upper body or head)",[74,75,76,77],"History of other contributing neurological or medical conditions known to affect cognitive functioning","Significant mental illness","Sensory impairments that limit ability to participate","History of alcohol or drug abuse\u002Fdependence","Inclusion Criteria:\n\n* Normal cognition for HC and diagnosis of Mild Cognitive Impairment (MCI) for MCI participants\n* Right-handedness\n* Magnetic resonance compatible, criteria that also apply for high definition transcranial direct current stimulation (HD-tDCS; e.g., absence of metallic or electronic implants in the upper body or head)\n\nExclusion Criteria:\n\n* History of other contributing neurological or medical conditions known to affect cognitive functioning\n* Significant mental illness\n* Sensory impairments that limit ability to participate\n* History of alcohol or drug abuse\u002Fdependence",[80,81],"ADULT","OLDER_ADULT",[83],{"facility":13,"status":8,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":96},"Ann Arbor","Michigan","48109","United States",[89,94],{"name":90,"role":91,"phone":92,"email":93},"Alexandru Iordan, Ph.D","CONTACT","734-764-2909","adiordan@med.umich.edu",{"name":90,"role":95},"PRINCIPAL_INVESTIGATOR",{"lat":97,"lon":98},42.27756,-83.74088,[100,104],{"name":101,"role":91,"phone":102,"email":103},"Harini Babu, MSc","734-647-3704","hariniba@umich.edu",{"name":105,"role":91,"phone":106,"email":107},"Eileen Robinson, RN-BC","734-763-1356","robinsoe@med.umich.edu",[109],{"name":110,"affiliation":13,"role":95},"Alexandru Iordan, PhD",[],[],{"nct_id":4,"conditions":114,"biomarkers":117},[115,116],"Healthy Control","Mild cognitive disorder",[],{"nct_id":4,"found":67,"summary":119,"prompt_version":129},{"design":120,"status":121,"heading":122,"summary":123,"follow_up":124,"word_count":125,"commitments":126,"compensation":127,"drugs_mentioned":128},"This is an interventional study involving 80 participants. It compares active HD-tDCS to a sham (placebo) treatment.","completed","Investigating Brain Stimulation for Mild Cognitive Impairment","This study is looking into how a type of non-invasive brain stimulation called high-definition transcranial direct current stimulation (HD-tDCS) affects brain function and memory. We want to understand if HD-tDCS can change brain activity and a brain chemical called glutamate in people with mild cognitive impairment (MCI) and healthy older adults. Participants will receive either active HD-tDCS or a sham (placebo) version for one 20-minute session. We'll use brain imaging (fMRS, fMRI, fNIRS) and memory tests to see these changes. The goal is to learn more about how the brain responds to this stimulation, which could help develop new treatments for conditions like Alzheimer's disease. You may be able to join if you are 60 or older, right-handed, and have normal cognition or a diagnosis of MCI. The study is currently recruiting 80 participants.","Changes in brain chemicals and activation will be measured at an average of one week after the intervention.",134,"You will receive one 20-minute session of either active or sham HD-tDCS. You will also undergo different forms of brain imaging and cognitive tests.","Not stated in the trial record.",[],"v2"]