[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07110376":3,"trial-entities:NCT07110376":116,"trial-summary:NCT07110376":119},{"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":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":38,"secondary_outcomes":43,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":15,"eligibility_criteria":70,"std_ages":85,"locations":88,"central_contacts":111,"overall_officials":113,"references":114,"see_also_links":115},"NCT07110376","25-323 DREAMS-PD","Deep Brain Stimulation Neural Recordings of Varied Stimulation During Sleep in Parkinson's Disease","Deep Brain Stimulation Neural Recordings of Varied Stimulation During Sleep in Parkinson's Disease - The DREAMS-PD Study","RECRUITING","2027-03-31","2025-10","2026-08-28","2025-11-22","The Cleveland Clinic","OTHER",false,"This study employs an exploratory, prospective, single center, naturalistic clinical trial design with a randomized crossover intervention.","Deep brain stimulation (DBS) stands as an established and robust treatment for various motor symptoms in patients with Parkinson's disease (PWP). While it has shown promise in ameliorating non-motor symptoms, the mechanisms underlying these improvements remain poorly understood. A significant forthcoming shift in the DBS landscape is the transition towards closed-loop or \"adaptive DBS\" (aDBS). This approach relies on expanding knowledge of basal ganglia electrophysiology and its correlation with motor symptoms. Augmented beta frequency oscillations (13-35 Hz) in local field potentials (LFP) from the basal ganglia is correlated with severity of the motor systems bradykinesia\u002Frigidity and serve as an electrophysiological biomarker for clinical state. Essentially, aDBS aims to modulate stimulation in response to neural state, offering more precise symptom control.\n\nSleep disturbances are a prevalent symptom in PWP, affecting a vast majority of patients, and serve as a significant non-motor contributor to quality of life. While DBS has demonstrated benefits in enhancing sleep efficiency and architecture, the mechanisms by which this might occur, as well as the optimal stimulation parameters for treating sleep dysfunctions are unknown. Sleep is associated with a dramatic change in subcortical neural activity compared to the wake state, with decreased beta activity, which could serve as a neurophysiological biomarker for the sleep state. Since beta frequencies are a common target for adaptive DBS studies in PD, addressing sleep-induced reductions in beta activity will be crucial for future algorithm development. Incorrectly interpreting sleep as the \"medication-on\" state may result in an adaptive algorithm providing the patient with non-optimal stimulation amplitudes that may adversely affect sleep.\n\nThere is an urgent need to identify the dose-response curve regarding how stimulation affects sleep quality and neurophysiology. Our primary objective is to address this knowledge gap by obtaining a comprehensive understanding of the subcortical neural signatures of sleep, and their correlation with sleep outcomes under different stimulation currents. This will ultimately enable us to establish the control policy for adaptive control of stimulation amplitude (current). Our central hypothesis is that different stimulation currents will elicit distinct effects on sleep subcortical neural signatures and sleep quality.",[19],"Parkinson Disease",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[24],"NA",{"count":26,"type":27},10,"ESTIMATED",[29],{"type":14,"name":30,"description":31,"armGroupLabels":32,"otherNames":34},"Nighttime Deep Brain Stimulation with Varying Amplitude Settings","Participants will undergo three different nighttime-only Deep Brain Stimulation (DBS) settings in a randomized crossover design: 0% amplitude (stimulation off), 50% amplitude of their optimal clinical DBS settings, and full clinical DBS settings (100%). Each setting is applied for two weeks during sleep, over a total six-week home monitoring period. The intervention is designed to assess how varying levels of subthalamic nucleus DBS influence sleep quality and neural oscillatory activity. Only nighttime DBS settings are modified; daytime settings remain unchanged.",[33],"Evaluate the Impact of Deep Brain Stimulation Settings on Sleep",[35,36,37],"Nocturnal DBS Amplitude Modulation","DBS Sleep Modulation Protocol","0%, 50%, 100% DBS Night Settings",[39],{"measure":40,"description":41,"timeFrame":42},"To demonstrate differences in sleep efficiency (SE) among different stimulation settings.","Sleep efficiency will be calculated as: (total sleep time ÷ total time in bed) × 100, using nightly data collected via the Dreem Headband. The mean SE for each 2-week stimulation setting (0%, 50%, 100% amplitude) will be compared within subjects using crossover analysis.","At the end of each 2-week stimulation period (over 6 weeks total)",[44,47,51,55,58,61,64],{"measure":45,"description":46,"timeFrame":42},"Average Nightly Beta Band Power","Average beta band power will be derived from subthalamic nucleus local field potentials recorded via the Medtronic Percept™ system.",{"measure":48,"description":49,"timeFrame":50},"Correlation Between Sleep Efficiency and Beta Band Power","The correlation between sleep efficiency (measured by Dreem Headband) and beta band power (recorded from DBS electrodes) will be evaluated. Analyses will include full-night averages and specific sleep stages (N1\u002FN2, N3).","Over each night during the 6-week study period",{"measure":52,"description":53,"timeFrame":54},"Correlation of Wake After Sleep Onset (WASO) with Beta Band Power","Wake after sleep onset (WASO) will be analyzed in relation to Deep Brain Stimulation (DBS) band power. Relationships will be examined across each stimulation condition and averaged over the study.","Across 6-week study period and at the end of each 2-week stimulation phase",{"measure":56,"description":57,"timeFrame":42},"Coherence Across Deep Brain Stimulation Amplitude Settings","Coherence between left and right subthalamic nucleus (STN) will be calculated. Comparisons will be made across the three stimulation settings",{"measure":59,"description":60,"timeFrame":54},"Correlation of sleep fragmentation index with Beta Band Power","Sleep fragmentation index will be analyzed in relation to Deep Brain Stimulation (DBS) band power. Relationships will be examined across each stimulation condition and averaged over the study.",{"measure":62,"description":63,"timeFrame":54},"Correlation of Pittsburgh Sleep Quality Index (PSQI) with Beta Band Power","Pittsburgh Sleep Quality Index (PSQI) will be analyzed in relation to Deep Brain Stimulation (DBS) band power. Relationships will be examined across each stimulation condition and averaged over the study.",{"measure":65,"description":66,"timeFrame":54},"Correlation of and Epworth Sleepiness Scale (ESS) with Beta Band Power","Epworth Sleepiness Scale (ESS) will be analyzed in relation to Deep Brain Stimulation (DBS) band power. Relationships will be examined across each stimulation condition and averaged over the study.","ALL","18 Years",null,{"inclusion":71,"exclusion":79,"raw_text":84},[72,73,74,75,76,77,78],"Male or female \\> 18 years of age","Diagnosed with idiopathic Parkinson Disease","Have bilateral implantation of Medtronic's PerceptTM PC (Medtronic Neurological Division, Minneapolis, MN, USA) Deep Brain Stimulation (DBS) system targeting the subthalamic nucleus (STN) and have had their stimulation settings optimized for a minimum of three months","Report a response score of one or greater on question 1.7 of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I;","Demonstrate ability to ambulate independently;","Be capable of providing informed consent;","If taking sleep-supporting medications, dosing must be stable for at least 30 days",[80,81,82,83],"Presence of neurological diseases other than Parkinson Disease, such as stroke or multiple sclerosis","Active sleep disorders, including narcolepsy, moderate to severe (Apnea-Hypopnea Index\\>=15) untreated sleep apnea, uncontrolled restless legs syndrome","Cognitive impairment meeting the criteria for dementia as per the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), based on formal neuropsychological evaluation","Ongoing alcohol or substance abuse; Working night shifts or irregular work hours","Inclusion Criteria:\n\n* Male or female \\> 18 years of age\n* Diagnosed with idiopathic Parkinson Disease\n* Have bilateral implantation of Medtronic's PerceptTM PC (Medtronic Neurological Division, Minneapolis, MN, USA) Deep Brain Stimulation (DBS) system targeting the subthalamic nucleus (STN) and have had their stimulation settings optimized for a minimum of three months\n* Report a response score of one or greater on question 1.7 of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I;\n* Demonstrate ability to ambulate independently;\n* Be capable of providing informed consent;\n* If taking sleep-supporting medications, dosing must be stable for at least 30 days\n\nExclusion Criteria:\n\n* Presence of neurological diseases other than Parkinson Disease, such as stroke or multiple sclerosis\n* Active sleep disorders, including narcolepsy, moderate to severe (Apnea-Hypopnea Index\\>=15) untreated sleep apnea, uncontrolled restless legs syndrome\n* Cognitive impairment meeting the criteria for dementia as per the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), based on formal neuropsychological evaluation\n* Ongoing alcohol or substance abuse; Working night shifts or irregular work hours\n\nThe main concern for vulnerable subjects will be for the possibility of reduced decision-making capacity. For this we intend to exclude individuals who have a diagnosis of dementia.",[86,87],"ADULT","OLDER_ADULT",[89],{"facility":90,"status":8,"city":91,"state":92,"zip":93,"country":94,"contacts":95,"geoPoint":108},"Cleveland Clinic","Cleveland","Ohio","441950001","United States",[96,101,105],{"name":97,"role":98,"phone":99,"email":100},"Project Manager","CONTACT","216-372-2867","beukemm@ccf.org",{"name":102,"role":98,"phone":103,"email":104},"Saar Anis, MD","216 678-8896","ANISS2@ccf.org",{"name":106,"role":107},"James Liao, MD","PRINCIPAL_INVESTIGATOR",{"lat":109,"lon":110},41.4995,-81.69541,[112],{"name":102,"role":98,"phone":103,"email":104},[],[],[],{"nct_id":4,"conditions":117,"biomarkers":118},[19],[],{"nct_id":4,"found":120,"summary":121,"prompt_version":131},true,{"design":122,"status":123,"heading":124,"summary":125,"follow_up":126,"word_count":127,"commitments":128,"compensation":129,"drugs_mentioned":130},"This is an interventional study with a randomized crossover design, meaning participants will try all three stimulation settings in a random order. It plans to enroll 10 participants.","completed","Deep Brain Stimulation for Sleep in Parkinson's Disease","This study is looking at how different settings of Deep Brain Stimulation (DBS) affect sleep in people with Parkinson's disease. Participants will have their existing Medtronic PerceptTM PC DBS system adjusted to three different settings during the night: off, 50% of their usual setting, and 100% of their usual setting. Each setting will be used for two weeks. The main goal is to see if there are differences in how well people sleep (sleep efficiency) with these different settings. You can join if you are over 18, have Parkinson's disease, and have had a bilateral Medtronic PerceptTM PC DBS system targeting the subthalamic nucleus (STN) for at least three months with optimized settings. The study plans to enroll 10 participants.","Sleep efficiency will be measured at the end of each 2-week stimulation period, over a total of 6 weeks.",120,"Participants will undergo three different nighttime-only Deep Brain Stimulation settings, each for a period of two weeks, for a total of six weeks.","Not stated in the trial record.",[],"v2"]