[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06956300":3,"trial-entities:NCT06956300":94,"trial-summary:NCT06956300":99},{"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":23,"study_type":25,"primary_purpose":14,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":43,"secondary_outcomes":55,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":15,"eligibility_criteria":59,"std_ages":63,"locations":66,"central_contacts":83,"overall_officials":91,"references":92,"see_also_links":93},"NCT06956300","2023A009489","TMS for Cognitive Decline in Aging and Preclinical AD","Grit Against Cognitive Decline in Aging and Preclinical Alzheimer's Disease","RECRUITING","2029-08-31","2026-02","2026-02-20","2025-04-07","Massachusetts General Hospital","OTHER",true,"In this research study we want to learn more about the effects of non-invasive brain stimulation on motivation, memory, and brain-network function in cognitively unimpaired older adults and individuals with preclinical Alzheimer's disease.\n\nThis study will use a form of non-invasive brain stimulation called repetitive Transcranial Magnetic Stimulation (rTMS). rTMS will slightly alter activity in an area of your brain that controls cognition. Changes resulting from this stimulation will be measured with behavioral tests, as well as by taking brain images with Magnetic Resonance Imaging (MRI).\n\nParticipants will come in for one baseline visit followed by 10 days of daily rTMS study visits (Monday through Friday) and an evaluation visit. Then, there will be a 2-week break. After this break, they will return for another baseline visit, an additional 10 days of rTMS, and a final evaluation visit.",null,[19,20,21,22],"Prodromal Alzheimer's Disease","Preclinical Alzheimer's Disease","Healthy Aging","Cognitive Decline",[24],"Transcranial Magnetic Stimulation","INTERVENTIONAL",[27],"NA",{"count":29,"type":30},80,"ESTIMATED",[32,38],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DEVICE","Active rTMS","All study participants will receive one block of ACTIVE rTMS. Each block will consist of daily sessions of active rTMS delivered to the left dorsolateral prefrontal cortex over ten days (Monday through Friday).",[37],"Active TMS",{"type":33,"name":39,"description":40,"armGroupLabels":41},"Sham rTMS","All study participants will receive one block of SHAM rTMS. Each block will consist of daily sessions of SHAM rTMS delivered to the left dorsolateral prefrontal cortex over ten days (Monday through Friday).",[42],"Sham TMS",[44,48,51],{"measure":45,"description":46,"timeFrame":47},"Changes in motivation","This will be measured by ratings of grit on a 5-point scale using the Grit Scale (Duckworth, et al., 2007).","Baseline and post-treatment Day 11",{"measure":49,"description":50,"timeFrame":47},"Changes in Brain Network Connectivity","This will include changes in resting-state functional connectivity measured with functional Magnetic Resonance Imaging (fMRI)",{"measure":52,"description":53,"timeFrame":54},"Changes in Memory","This will be measured with an associative memory task","Baseline and Post-Treatment Day 11",[],"ALL","40 Years","99 Years",{"inclusion":60,"exclusion":61,"raw_text":62},[],[],"Inclusion Criteria:\n\n1. Between the ages of 40-99\n2. Native English speakers\n3. Willing and able to consent to the protocol and undergo imaging and neuropsychological testing at the specified time points\n4. Cognitively normal older adults and individuals with preclinical Alzheimer's disease will be included.\n\nExclusion Criteria:\n\n1. History of head trauma involving loss of consciousness or alteration in consciousness\n2. Another major neurologic or psychiatric condition\n3. Known presence of a structural brain lesion (e.g. tumor, cortical infarct)\n4. Any contraindication to MRI, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body\n5. Longstanding premorbid history (i.e. longer than 10 years) of alcohol or substance abuse with continuous abuse up to and including the time that the symptoms leading to clinical presentation developed\n6. Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol.\n7. Unwilling to return for follow-up, undergo neuropsychological testing, TMS, and MR imaging\n8. History of unprovoked seizures (i.e., seizures that occur in the absence of a clear provocation such as hyponatremia, hypoglycemia, etc.).\n9. Subjects who have a first degree relative (e.g., father, mother or sibling) with a seizure disorder.\n10. Subjects currently taking, or plan to take, medications which are highly epileptogenic. These include: clozapine, high doses of bupropion (i.e., greater than 400mg daily), diphenhydramine, cyclosporine, isoniazid, imipenem, chloroquine, tramadol and theophylline.",[64,65],"ADULT","OLDER_ADULT",[67],{"facility":13,"status":8,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":80},"Boston","Massachusetts","02129","United States",[73,78],{"name":74,"role":75,"phone":76,"email":77},"Alexandra Touroutoglou, MSc, PhD","CONTACT","617-643-6348","atouroutoglou@mgh.harvard.edu",{"name":74,"role":79},"PRINCIPAL_INVESTIGATOR",{"lat":81,"lon":82},42.35843,-71.05977,[84,87],{"name":85,"role":75,"phone":86,"email":77},"Alexandra Touroutoglou, PhD","6176436348",{"name":88,"role":75,"phone":89,"email":90},"Jordan Walter, BA","6177266207","jwalter2@mgh.harvard.edu",[],[],[],{"nct_id":4,"conditions":95,"biomarkers":98},[96,97,21],"Alzheimer's Disease","Cognitive Dysfunction",[],{"nct_id":4,"found":15,"summary":100,"prompt_version":110},{"design":101,"status":102,"heading":103,"summary":104,"follow_up":105,"word_count":106,"commitments":107,"compensation":108,"drugs_mentioned":109},"This interventional study plans to enroll 80 participants. All participants will receive both active rTMS and sham rTMS.","completed","rTMS for Cognitive Decline in Aging and Preclinical Alzheimer's Disease","This study is exploring how a type of non-invasive brain stimulation called repetitive Transcranial Magnetic Stimulation (rTMS) affects motivation, memory, and brain function in older adults. This includes people with healthy aging, cognitive decline, and early stages of Alzheimer's disease (prodromal and preclinical Alzheimer's disease). All participants will receive both active rTMS and sham rTMS (a placebo version) to the left side of the brain that controls thinking. Researchers will measure changes in motivation, memory, and brain network connections to see if rTMS is helpful. You may be able to join if you are between 40 and 99 years old, a native English speaker, and willing to undergo testing and imaging.","Changes in motivation, brain network connectivity, and memory will be measured at Baseline and post-treatment Day 11.",111,"You will have a baseline visit, followed by 10 daily rTMS sessions (Monday-Friday), an evaluation visit, and then a 2-week break.","Not stated in the trial record.",[34,39],"v2"]