[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05471960":3,"trial-entities:NCT05471960":133,"trial-summary:NCT05471960":137},{"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":22,"primary_purpose":17,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":72,"sex":73,"minimum_age":74,"maximum_age":75,"healthy_volunteers":76,"eligibility_criteria":77,"std_ages":105,"locations":108,"central_contacts":126,"overall_officials":128,"references":131,"see_also_links":132},"NCT05471960","NEUR-2022-30985","Neuroplasticity in RBD","Neuroplasticity in REM Sleep Behavior Disorder","RECRUITING","2027-07-31","2026-08","2026-08-27","2023-04-21","University of Minnesota","OTHER",false,"REM sleep behavior disorder is a parasomnia that reflects the presence of alpha-synucleinopathy in the brain and is highly predictive of eventual phenoconversion to Parkinson's disease, dementia with Lewy bodies, or multiple system atrophy over the course of years to decades. Neuroplastic adaptations in the brain during the prodromal stage of disease are thought to mask the expression of motor and non-motor signs and may substantially delay diagnosis during a potentially critical time window. This study will examine the state and progression (over 30 to 36 months) of neuroplastic changes in the excitability of the motor and prefrontal cortex (using transcranial magnetic stimulation), the structural and functional connectivity of the brain (using highfield, 7T, magnetic resonance imaging), and the relationship of these changes to the expression of motor and neuropsychological signs, in a cohort of individuals with REM sleep behavior disorder and matched controls.",null,[19],"REM Sleep Behavior Disorder",[21],"iRBD","OBSERVATIONAL",[],{"count":25,"type":26},86,"ESTIMATED",[28],{"type":14,"name":29,"description":30,"armGroupLabels":31},"Natural progression over time","Each subject will attend eight testing sessions (MRI scanning, two TMS-motor test visits, two TMS-prefrontal test visits, motor assessments, neuropsychological testing, and overnight sleep testing (polysomnography - PSG).",[32,33],"Control Group: Progression over time","iRBD Group: Progression over time",[35,39,42,45,47,49,51,53,55,58,60,62,64,66,68,70],{"measure":36,"description":37,"timeFrame":38},"MRI Progression over 30 to 36 months","Yes\u002FNo whether a change was observed from baseline","30 to 36 months from baseline",{"measure":40,"description":41,"timeFrame":38},"Change in Beck Depression Inventory score","Higher score means more impairment",{"measure":43,"description":44,"timeFrame":38},"Change in Mattis Dementia Rating Scale","Higher score means less impairment",{"measure":46,"description":44,"timeFrame":38},"Change in Rey Complex Figure",{"measure":48,"description":44,"timeFrame":38},"Change in WAIS-IV Matrix Reasoning",{"measure":50,"description":44,"timeFrame":38},"Change in Stroop Color",{"measure":52,"description":44,"timeFrame":38},"Change in Stroop Word",{"measure":54,"description":44,"timeFrame":38},"Change in Stroop Color Word",{"measure":56,"description":57,"timeFrame":38},"Change in Wisconsin Card Sorting Test","Higher score means more impairment for subsections \"# persev errors\" and FMS; less impairment for subsections \"# categories\" and conceptualization",{"measure":59,"description":44,"timeFrame":38},"Change in D-KEFS",{"measure":61,"description":44,"timeFrame":38},"Change in BVMT-R",{"measure":63,"description":44,"timeFrame":38},"Change in HVLT",{"measure":65,"description":44,"timeFrame":38},"Change in WMS-3 Spatial Span",{"measure":67,"description":44,"timeFrame":38},"Change in Boston Naming Test",{"measure":69,"description":41,"timeFrame":38},"Change in Trail Making Test A",{"measure":71,"description":41,"timeFrame":38},"Change in Trail Making Test B",[],"ALL","21 Years","75 Years",true,{"inclusion":78,"exclusion":83,"raw_text":104},[79,80,81,81,82],"Diagnosis of polysomnogram-confirmed isolated iRBD.","Able to ambulate independently without the use of an assistive device (e.g., cane) for 50 meters.","Age: 21-75 years.","Able to ambulate independently without the use of an assistive device (e.g., cane or walker for 50 meters.",[84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103],"Dementia diagnosis and\u002For a University of California Brief Assessment of Capacity to Consent (UBACC) score and MacCAT-CR score indicating impaired capacity to consent.","History of musculoskeletal disorders that significant affect movement of lower or upper limbs as determined at the time of enrollment.","Other significant neurological disorders that may affect participation or performance in the study.","Anti-depressant associated RBD. Individuals will be excluded if their dream enactment emerged or clearly worsened after initiating an antidepressant medication.","Meet criteria for overt Parkinson's disease, dementia with Lewy bodies, Multiple Systems Atrophy, Alzheimer's disease, or other neurodegenerative disorder, or other known cause of RBD (e.g., narcolepsy and drug induced RBD).","Untreated sleep-disordered breathing","History of musculoskeletal disorders that significantly affect movement of lower or upper limbs as determined at the time of enrollment.","Pregnant women","History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury","Recent history of frequent syncope (fainting) episodes in response to blood, emotional stress, or sensory triggers.","Intracranial metallic or magnetic devices (e.g. cochlear implant, deep brain stimulator)","Pacemaker or any implanted device","History of surgery on blood vessels, brain, or heart","Unexplained, recurring headaches or concussion within the last six months","Severe hearing impairment","If participant is taking one of the following medications that affects neuroplasticity testing, they will be excluded from the TMS experiment: haloperidol (dopamine antagonist), prazosin (norepinephrine antagonist), biperiden (acetylcholine antagonist), dopamine modulators, NMDA receptor and calcium channel modulators, GABAergic drugs (benzodiazepines), lithium, lovastatin, and cannabis.","History of dream enactment from either patient report or from a bed partner witness that may suggest iRBD.","History of untreated sleep-disordered breathing.","Presence of parkinsonism or cognitive impairment (including dementia or mild cognitive impairment).","Active central nervous system, systemic, psychiatric conditions or use of psychoactive medication that would adversely affect cognitive, neuropsychiatric, motor, or autonomic functioning","Inclusion Criteria for the iRBD Group:\n\n* Diagnosis of polysomnogram-confirmed isolated iRBD.\n* Able to ambulate independently without the use of an assistive device (e.g., cane) for 50 meters.\n* Age: 21-75 years.\n\nInclusion Criteria For Control Subject Group:\n\n* Age: 21-75 years.\n* Able to ambulate independently without the use of an assistive device (e.g., cane or walker for 50 meters.\n\nExclusion criteria for iRBD group:\n\n* Dementia diagnosis and\u002For a University of California Brief Assessment of Capacity to Consent (UBACC) score and MacCAT-CR score indicating impaired capacity to consent.\n* History of musculoskeletal disorders that significant affect movement of lower or upper limbs as determined at the time of enrollment.\n* Other significant neurological disorders that may affect participation or performance in the study.\n* Anti-depressant associated RBD. Individuals will be excluded if their dream enactment emerged or clearly worsened after initiating an antidepressant medication.\n* Meet criteria for overt Parkinson's disease, dementia with Lewy bodies, Multiple Systems Atrophy, Alzheimer's disease, or other neurodegenerative disorder, or other known cause of RBD (e.g., narcolepsy and drug induced RBD).\n* Untreated sleep-disordered breathing\n* History of musculoskeletal disorders that significantly affect movement of lower or upper limbs as determined at the time of enrollment.\n* Pregnant women\n* Additional exclusion criteria for TMS experiments (note that individuals who are excluded from the TMS experiment still have the opportunity to participate in the other data collection sessions):\n\n  * History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury\n  * Recent history of frequent syncope (fainting) episodes in response to blood, emotional stress, or sensory triggers.\n  * Intracranial metallic or magnetic devices (e.g. cochlear implant, deep brain stimulator)\n  * Pacemaker or any implanted device\n  * History of surgery on blood vessels, brain, or heart\n  * Unexplained, recurring headaches or concussion within the last six months\n  * Severe hearing impairment\n  * If participant is taking one of the following medications that affects neuroplasticity testing, they will be excluded from the TMS experiment: haloperidol (dopamine antagonist), prazosin (norepinephrine antagonist), biperiden (acetylcholine antagonist), dopamine modulators, NMDA receptor and calcium channel modulators, GABAergic drugs (benzodiazepines), lithium, lovastatin, and cannabis.\n\nExclusion Criteria for Control subject Group:\n\n* Same as exclusion criteria as the iRBD group\n* History of dream enactment from either patient report or from a bed partner witness that may suggest iRBD.\n* History of untreated sleep-disordered breathing.\n* Presence of parkinsonism or cognitive impairment (including dementia or mild cognitive impairment).\n* Active central nervous system, systemic, psychiatric conditions or use of psychoactive medication that would adversely affect cognitive, neuropsychiatric, motor, or autonomic functioning",[106,107],"ADULT","OLDER_ADULT",[109],{"facility":13,"status":8,"city":110,"state":111,"zip":112,"country":113,"contacts":114,"geoPoint":123},"Minneapolis","Minnesota","55455","United States",[115,120],{"name":116,"role":117,"phone":118,"email":119},"Madison Wylie, MS","CONTACT","612-505-8325","aasen056@umn.edu",{"name":121,"role":122},"Colum MacKinnon, PhD","PRINCIPAL_INVESTIGATOR",{"lat":124,"lon":125},44.97997,-93.26384,[127],{"name":116,"role":117,"phone":118,"email":119},[129],{"name":130,"affiliation":13,"role":122},"Colum MacKinnon, Ph.D",[],[],{"nct_id":4,"conditions":134,"biomarkers":136},[135],"REM sleep behavior disorder",[],{"nct_id":4,"found":76,"summary":138,"prompt_version":148},{"design":139,"status":140,"heading":141,"summary":142,"follow_up":143,"word_count":144,"commitments":145,"compensation":146,"drugs_mentioned":147},"This interventional study plans to enroll 86 participants, including those with confirmed isolated RBD and a control group.","completed","Neuroplasticity in REM Sleep Behavior Disorder Study","This study is looking at how the brain changes over time in people with REM Sleep Behavior Disorder (RBD). RBD is a sleep condition that often leads to other brain diseases like Parkinson's. Researchers want to understand how the brain adapts to these changes, which might delay diagnosis. You would participate in eight testing sessions over 30 to 36 months. These sessions include MRI scans, brain stimulation tests (TMS), motor and memory assessments, and overnight sleep studies. The study aims to see how brain changes, depression scores, and memory scores progress over this time. It's open to people aged 21 to 75 who can walk independently, with or without RBD.","Participants will be followed for 30 to 36 months to track changes in MRI, depression scores, and memory scores.",110,"You would attend eight testing sessions over 30 to 36 months, including MRI scans, TMS tests, motor and neuropsychological assessments, and overnight sleep studies (polysomnography).","Not stated in the trial record.",[],"v2"]