[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07461584":3,"trial-entities:NCT07461584":114,"trial-summary:NCT07461584":117},{"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":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":51,"secondary_outcomes":65,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":69,"eligibility_criteria":70,"std_ages":88,"locations":90,"central_contacts":106,"overall_officials":109,"references":112,"see_also_links":113},"NCT07461584","4230E_3","Memory Enhancement in Aging With Optimal Dosing","Personalized Memory Enhancement in Aging: Pattern-Optimized tACS With Closed-Loop Precision Modulation","RECRUITING","2031-01-31","2026-07","2026-07-22","2026-06-01","Boston University Charles River Campus","OTHER",false,"This project optimizes high-resolution transcranial Alternating Current Stimulation (tACS) to improve memory in healthy older adults, advancing drug-free approaches for Alzheimer's disease and related dementia (ADRD). We test stimulation schedules and develop an adaptive, brain-guided tACS system to strengthen memory-supporting networks.","Cognitive decline, especially in memory and executive control, poses an escalating public health challenge as the population ages, contributing to loss of independence, reduced quality of life, and increased healthcare costs associated with Alzheimer's disease and related dementias (ADRD). Despite decades of research, there are few effective, non-pharmacological interventions capable of slowing or reversing these cognitive losses. Transcranial alternating current stimulation (tACS) has recently emerged as a promising, safe, and non-invasive technique for modulating neural rhythms that support memory. However, existing approaches remain limited by one-size-fits-all stimulation schedules that fail to account for individual brain connectivity patterns or dynamic fluctuations in cognitive state.\n\nThis project aims to advance precision neuromodulation for cognitive aging by optimizing and personalizing high-resolution tACS protocols to enhance memory in older adults. Building on strong pilot data demonstrating the feasibility of personalized and adaptive stimulation, we will use multimodal imaging (EEG and fMRI) to track changes in frontotemporal synchrony, specifically theta-gamma phase-amplitude coupling and theta phase synchronization, that are known to support memory formation and retrieval.\n\nAim 1 will establish how stimulation pattern (patterned vs. continuous waveforms) and schedule (one, three, or five consecutive days) shape the durability of memory enhancement. By comparing six systematically varied dosing protocols, we will determine the optimal pattern and repetition schedule that maximize and sustain improvements in working memory capacity, interference control, and long-term memory recognition over one month.\n\nBy integrating behavioral, electrophysiological, and neuroimaging measures with adaptive control algorithms, this research will identify reliable biomarkers of responsiveness, elucidate causal mechanisms linking neural synchrony to memory, and yield a new class of personalized, connectivity-guided interventions for cognitive decline. The findings will lay a foundation for scalable, non-invasive, and mechanism-driven treatments for ADRD and age-related memory loss, advancing the broader NIH mission of promoting healthy cognitive aging.",[19,20,21],"Aging","Noninvasive Brain Stimulation","Memory",[],"INTERVENTIONAL","BASIC_SCIENCE",[26],"NA",{"count":28,"type":29},240,"ESTIMATED",[31,36,39,42,45,48],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DEVICE","1-day patterned tACS","Device: High definition transcranial electrical current stimulation Low-intensity, noninvasive application of electrical current to the human scalp with the goal of modulating levels of neuronal excitability.",[33],{"type":32,"name":37,"description":34,"armGroupLabels":38},"3-day patterned tACS",[37],{"type":32,"name":40,"description":34,"armGroupLabels":41},"5-day patterned tACS",[40],{"type":32,"name":43,"description":34,"armGroupLabels":44},"1-day continuous tACS",[43],{"type":32,"name":46,"description":34,"armGroupLabels":47},"3-day continuous tACS",[46],{"type":32,"name":49,"description":34,"armGroupLabels":50},"5-day continuous tACS",[49],[52,56,59,62],{"measure":53,"description":54,"timeFrame":55},"Visual working memory capacity measured behaviorally","Behavioral k-capacity estimate derived from the change-detection task","Baseline, 1-week after intervention, 1-month after intervention",{"measure":57,"description":58,"timeFrame":55},"Interruption suppression measured behaviorally","Memory accuracy performance difference between interruption and control trials on the interruption working memory task",{"measure":60,"description":61,"timeFrame":55},"EEG phase locking value (PLV) during working memory retention","Phase locking value between frontotemporal EEG electrodes within the theta frequency band during the memory retention interval of the visual working memory task",{"measure":63,"description":64,"timeFrame":55},"EEG phase amplitude coupling (PAC) during working memory retention","Theta phase gamma amplitude cross-frequency coupling at temporal EEG electrodes during the memory retention interval of the visual working memory task",[],"ALL","65 Years",null,true,{"inclusion":71,"exclusion":75,"raw_text":87},[72,73,74],"65 years of age or older","normal or corrected-to-normal vision","color vision",[76,77,78,79,80,81,82,83,84,85,86],"pregnant","metal implants in head","implanted electronic devices","history of neurological problems or head injury","skin sensitivity","claustrophobia","dementia (normal Montreal Cognitive Assessment \\> 25)","depression (normal Geriatric Depression Scale \\\u003C 10)","history of psychosis","cognitive deficits (MoCA\\>25)","any psychoactive medication","Inclusion Criteria:\n\n* 65 years of age or older\n* normal or corrected-to-normal vision\n* color vision\n\nExclusion Criteria:\n\n* pregnant\n* metal implants in head\n* implanted electronic devices\n* history of neurological problems or head injury\n* skin sensitivity\n* claustrophobia\n* dementia (normal Montreal Cognitive Assessment \\> 25)\n* depression (normal Geriatric Depression Scale \\\u003C 10)\n* history of psychosis\n* cognitive deficits (MoCA\\>25)\n* any psychoactive medication",[89],"OLDER_ADULT",[91],{"facility":92,"status":8,"city":93,"state":94,"zip":95,"country":96,"contacts":97,"geoPoint":103},"111 Cummington Mall","Boston","Massachusetts","02215","United States",[98],{"name":99,"role":100,"phone":101,"email":102},"Robert Reinhart, PhD","CONTACT","617-353-9481","rmgr@bu.edu",{"lat":104,"lon":105},42.35843,-71.05977,[107],{"name":99,"role":100,"phone":108,"email":102},"(617) 353-9481",[110],{"name":99,"affiliation":13,"role":111},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":115,"biomarkers":116},[19],[],{"nct_id":4,"found":69,"summary":118,"prompt_version":127},{"design":119,"status":120,"heading":6,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This is an interventional study planning to enroll 240 participants. It is testing different schedules of transcranial alternating current stimulation (tACS).","completed","This study is looking into ways to improve memory in healthy older adults using a non-drug approach called transcranial alternating current stimulation (tACS). This involves applying a low-intensity electrical current to the scalp to help brain networks that support memory. Researchers are testing different schedules of tACS, including 1-day, 3-day, and 5-day treatments, to find the best way to enhance memory. The goal is to develop drug-free options for memory decline often seen in aging and conditions like Alzheimer's disease. You might be able to join if you are 65 or older, have good vision, and do not have certain medical conditions like metal implants in your head or a history of neurological problems. The study will measure your visual working memory and how well you can stop interruptions at the start, one week, and one month after the treatment.","Participants will be followed for one month after the intervention to measure memory and brain activity.",140,"You would have your memory and brain activity (EEG) measured at the start, one week after treatment, and one month after treatment. The study involves receiving tACS for 1, 3, or 5 days.","Not stated in the trial record.",[],"v2"]