[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07701785":3,"trial-entities:NCT07701785":123,"trial-summary:NCT07701785":127},{"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":21,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":41,"secondary_outcomes":57,"sex":82,"minimum_age":83,"maximum_age":84,"healthy_volunteers":85,"eligibility_criteria":86,"std_ages":101,"locations":104,"central_contacts":119,"overall_officials":120,"references":121,"see_also_links":122},"NCT07701785","Pro00151225","Superior Parietal iTBS for PD-MCI","Accelerated Intermittent Theta Burst Stimulation for Mild Cognitive Impairment in Parkinson's Disease","RECRUITING","2028-04-30","2026-07","2026-07-14","2026-08-01","Medical University of South Carolina","OTHER",true,"The goal of this study is to determine the whether a short-term, high-dose form of non-invasive brain stimulation (intermittent theta burst stimulation; iTBS) is a promising and safe treatment for mild cognitive impairment in Parkinson's disease (PD-MCI).","Dementia occurs in 80% of people with Parkinson's disease (PD) within 20 years of diagnosis. Cognitive interventions in PD have centered on individuals with mild cognitive impairment (PD-MCI). A lack of efficacy of pharmacological interventions in PD-MCI has driven interest in nonpharmacological approaches. The most promising of these is intermittent theta burst stimulation (iTBS), a noninvasive brain stimulation method that is FDA-approved for several psychiatric conditions. Though iTBS has shown little to no benefit in PD-MCI thus far, there are modifiable issues with past interventions including exclusively targeting prefrontal cortex when cholinergic denervation in posterior cortex is strongly associated with cognitive decline in PD, and substantial underdosing compared to efficacious iTBS interventions (6,000 vs at least 18,000 pulses). Interventions will likely have better outcomes if they target the right superior parietal lobule (rSPL), a cortical region impacted by cholinergic denervation in PD that is essential to maintaining attention, and use accelerated iTBS (a-iTBS) to deliver a stimulation dose commensurate with FDA-approved protocols in a shorter timeframe. However, before the efficacy of such an intervention can be evaluated, it must be established as safe, tolerable and feasible in PD-MCI. This project therefore aims to evaluate the safety, tolerability and feasibility of a three-day a-iTBS intervention stimulating the rSPL with 18,000 total pulses.",[19,20],"Parkinson Disease","Mild Cognitive Impairment",[22,23,24,25,26],"Transcranial Magnetic Stimulation","Theta Burst Stimulation","Parkinson's Disease","Cognitive Impairment","Neuromodulation","INTERVENTIONAL","TREATMENT",[30],"NA",{"count":32,"type":33},30,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39},"DEVICE","Accelerated intermittent theta-burst stimulation (iTBS) rTMS to right superior parietal lobule (rSPL)","Participants in this single-arm study will receive a accelerated course of intermittent theta burst stimulation (iTBS) over superior parietal lobule, which is identified with MNI coordinates from past studies. The stimulation will be delivered using a MagVenture MagPro TMS System with a butterfly, active cooling coil at 120% of resting motor threshold.\n\nEach participant will complete 3 consecutive treatment days, undergoing10 rTMS sessions per day (600 pulses\u002Fsession), totaling 18,000 pulses across the study. Safety, tolerability, adherence, and feasibility data will be collected for the intervention.",[40],"Accelerated iTBS",[42,46,50,53],{"measure":43,"description":44,"timeFrame":45},"Serious Adverse Events","Number of serious adverse events experienced by study participants caused by the iTBS protocol","Week 4, 5 minutes before and 5 minutes after stimulation sessions on Days 1-3",{"measure":47,"description":48,"timeFrame":49},"Feasibility of the study protocol","Feasibility will be defined as the proportion of participants enrolled that complete all intervention procedures","Week 0 through completion of study (8 weeks)",{"measure":51,"description":52,"timeFrame":45},"Tolerability of TMS procedures","A questionnaire evaluating the presence and severity of commonly experienced side effects of TMS (i.e. headache, pain, scalp irritation, facial twitching, fatigue, fear\u002Fanxiety) within the past 24 hours and during stimulation. Ratings will be on a 6-point Likert scale from 0 (no symptoms) to 5 (severe symptoms).",{"measure":54,"description":55,"timeFrame":56},"Test-retest reliability of the Continuous Temporal Expectancy Test (CTET)","The CTET is a tablet-administered measure designed to assess sustained attention and distractibility. Participants will be shown a grid with black and white squares on a tablet that rotate after either a longer duration (target stimulus; 1070ms) or a shorter duration (non-target stimulus; 800ms) and must press the screen when they identify a target stimulus. Participants will complete 10 one-minute trials. Half of the trials are performed without a distractor present, and the other half are performed with an audio-video distractor presented on an adjacent laptop screen. The primary outcome is the distractibility score, defined as the difference in latency (in ms) to identifying the target stimulus between distractor and non-distractor trials.","Week 0 (4 weeks pre-intervention) to Week 4, Day 1 (30 minutes prior to intervention)",[58,62,66,70,74,78],{"measure":59,"description":60,"timeFrame":61},"Change in Continuous Temporal Expectancy Task (CTET) Distractibility Score","Change in CTET Distractibility Score (\\[distraction trial latency in ms\\] - \\[non-distraction trial latency in ms\\]). Higher scores indicate worse performance.","Week 4, Day 1 (30 minutes prior to intervention) to Week 4, Day 3 (15 minutes after intervention) to Week 8 (4 weeks post-intervention)",{"measure":63,"description":64,"timeFrame":65},"Change in NIH Toolbox Cognitive Battery (NIHTB-CB) Composite Scores","The NIHTB-CB is a performance-based, iPad-administered suite of 7 tests that ascertain abilities in different cognitive domains (i.e. executive function, episodic memory, working memory, processing speed, language). It was developed using advanced psychometric techniques to minimize measurement error and produces normed subtest and composite scores. We will use the fully-corrected T-score (range T=0-100; Mean T=50, SD=10; higher scores indicating better cognition) of the Fluid Cognition Composite and Crystallized Cognition Composite, which are normed for age, sex, years of education, and race\u002Fethnicity.","Week 4, Day 1 (30 minutes prior to intervention intervention) to Week 4, Day 3 (15 minutes after intervention) to Week 8 (4 weeks post-intervention)",{"measure":67,"description":68,"timeFrame":69},"Change in daily functioning","Change in caregiver ratings on the ECog-12, a questionnaire designed to measure the participant's everyday cognition and functional decline based on 12 Likert scale items ranging from 1 (no change compared to 10 years earlier) to 4 (consistently much worse).","Week 0 (1 month pre-intervention) to Week 8 (1 month post-intervention)",{"measure":71,"description":72,"timeFrame":73},"Change in Beck Depression Inventory II (BDI-II) Raw Score","The Beck Depression Inventory II (BDI-II) is a self-report measure of depressive symptoms comprised of 21 questions rated on a Likert scale from 0 (least severe) to 3 (most severe).","Week 4, Day 1 (pre-intervention) to Week 8 (1 month post-intervention)",{"measure":75,"description":76,"timeFrame":77},"Change in Beck Anxiety Inventory (BAI) Score","The Beck Anxiety Inventory (BAI) is a self-report measure of depressive symptoms comprised of 21 questions rated on a Likert scale from 0 (least severe) to 3 (most severe).","Week 1, Day 1 (pre-intervention) to Week 8 (one-month follow-up)",{"measure":79,"description":80,"timeFrame":81},"Change in Apathy Evaluation Scale (AES) Raw Score","The Apathy Evaluation Scale is a self-report measure of apathy symptoms comprised of 18 Likert scale items rated from 0 (least severe) to 3 (most severe).","Week 4, Day 1 (pre-intervention) to Week 8 (1-month post-intervention)","ALL","50 Years","85 Years",false,{"inclusion":87,"exclusion":93,"raw_text":100},[88,89,90,91,92],"50-85 years of age","Diagnosis of Parkinson's disease based on UK Brain Bank diagnostic criteria","Parkinson's disease with mild cognitive impairment (PD-MCI) diagnosis per Movement Disorders Society Task Force Level II Diagnostic Criteria4 (i.e., scores ≥1.5 standard deviations below appropriate norms on 2 neuropsychological tests) as determined by a clinical neuropsychologist","Stable on Parkinson's disease medications for 30 days (not expected to change through the course of the treatment)","Has a caregiver willing and able to reliably complete a questionnaire focused on the participant's daily functioning",[94,95,96,97,98,99],"Claustrophobia or inability to lie supine in the scanner for an extended period of time","Barriers to making contact between the TMS coil and the skin (e.g. braids that cannot be removed)","Contraindications to MRI\u002FTMS safety screening: This includes but is not limited to implanted medical devices (e.g., pacemakers), metallic objects or fragments, non-removable hair clips or piercings, and medications that reduce seizure threshold.","Individuals with a diagnosis of bipolar disorder, schizophrenia, and\u002For active substance abuse disorder.","History of significant or unstable condition\u002Fs or treatments for these condition\u002Fs that may impact cognition (as determined by the study investigators) such as significant cardiac (e.g. heart failure), infectious (e.g. HIV, urinary tract infection), or metabolic disease (e.g. labile diabetes), cancer (e.g. brain cancer, chemotherapy-induced cognitive impairment), developmental disorder (e.g. autism spectrum disorder, intellectual disability), or other neurologic disease (e.g. multiple sclerosis, moderate to severe brain injury, seizures).","History of a seizure disorder.","Inclusion Criteria:\n\n* 50-85 years of age\n* Diagnosis of Parkinson's disease based on UK Brain Bank diagnostic criteria\n* Parkinson's disease with mild cognitive impairment (PD-MCI) diagnosis per Movement Disorders Society Task Force Level II Diagnostic Criteria4 (i.e., scores ≥1.5 standard deviations below appropriate norms on 2 neuropsychological tests) as determined by a clinical neuropsychologist\n* Stable on Parkinson's disease medications for 30 days (not expected to change through the course of the treatment)\n* Has a caregiver willing and able to reliably complete a questionnaire focused on the participant's daily functioning\n\nExclusion Criteria:\n\n* Claustrophobia or inability to lie supine in the scanner for an extended period of time\n* Barriers to making contact between the TMS coil and the skin (e.g. braids that cannot be removed)\n* Contraindications to MRI\u002FTMS safety screening: This includes but is not limited to implanted medical devices (e.g., pacemakers), metallic objects or fragments, non-removable hair clips or piercings, and medications that reduce seizure threshold.\n* Individuals with a diagnosis of bipolar disorder, schizophrenia, and\u002For active substance abuse disorder.\n* History of significant or unstable condition\u002Fs or treatments for these condition\u002Fs that may impact cognition (as determined by the study investigators) such as significant cardiac (e.g. heart failure), infectious (e.g. HIV, urinary tract infection), or metabolic disease (e.g. labile diabetes), cancer (e.g. brain cancer, chemotherapy-induced cognitive impairment), developmental disorder (e.g. autism spectrum disorder, intellectual disability), or other neurologic disease (e.g. multiple sclerosis, moderate to severe brain injury, seizures).\n* History of a seizure disorder.",[102,103],"ADULT","OLDER_ADULT",[105],{"facility":13,"status":8,"city":106,"state":107,"zip":108,"country":109,"contacts":110,"geoPoint":116},"Charleston","South Carolina","29425","United States",[111],{"name":112,"role":113,"phone":114,"email":115},"Sam Crowley, PhD","CONTACT","843-792-7767","crowleys@musc.edu",{"lat":117,"lon":118},32.77632,-79.93275,[],[],[],[],{"nct_id":4,"conditions":124,"biomarkers":126},[125,19],"Mild cognitive disorder",[],{"nct_id":4,"found":15,"summary":128,"prompt_version":138},{"design":129,"status":130,"heading":131,"summary":132,"follow_up":133,"word_count":134,"commitments":135,"compensation":136,"drugs_mentioned":137},"This is a single-arm study, meaning all 30 participants will receive the accelerated intermittent theta-burst stimulation (iTBS). The phase of the study is not specified.","completed","Brain Stimulation for Parkinson's Disease with Mild Cognitive Impairment","This study is looking at a type of non-invasive brain stimulation called accelerated intermittent theta-burst stimulation (iTBS) to see if it's a promising and safe treatment for mild cognitive impairment (MCI) in people with Parkinson's disease (PD-MCI). The stimulation is delivered to a specific area of the brain called the right superior parietal lobule (rSPL). We want to see if this treatment is safe and tolerable, and if the study plan is practical. You may be able to join if you are 50-85 years old and have been diagnosed with Parkinson's disease and mild cognitive impairment. This study plans to enroll 30 participants, but its current status is unclear.","Safety and tolerability are measured at Week 4, and the feasibility of the study protocol is measured through completion of the study (8 weeks).",109,"You will receive accelerated intermittent theta-burst stimulation (iTBS) over several days. Safety and tolerability will be checked before and after stimulation sessions on Days 1-3, and the study will last for 8 weeks.","Not stated in the trial record.",[],"v2"]