[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06275685":3,"trial-entities:NCT06275685":106,"trial-summary:NCT06275685":110},{"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":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":46,"sex":65,"minimum_age":66,"maximum_age":67,"healthy_volunteers":15,"eligibility_criteria":68,"std_ages":81,"locations":85,"central_contacts":100,"overall_officials":103,"references":104,"see_also_links":105},"NCT06275685","CIP-0001510","Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking","Forecasting Seizures Using IntelliGent Wearable Technology for Health Tracking","RECRUITING","2026-06","2024-09","2024-09-19","2024-04-11","Empatica, Inc.","INDUSTRY",false,"The goal of this interventional study is to develop a personalized seizure risk forecast tool in people with epilepsy.\n\nThe main questions it aims to answer are:\n\n* can we develop a future seizure probabilities tool that is more accurate than chance based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables.\n* does this tool improve the lives of people with epilepsy?\n\nResearchers will compare a group that does not have access to the forecast tool to a group that does and see if it is accurate and if people with it report that it improved their quality of life.","The primary goal of the study is to demonstrate the accuracy of SeizureWise in predicting the timing of future convulsive seizures using data collected by the wearable EmbracePlus device and data provided by patients with GTCS monitored in outpatient settings.\n\nThe secondary goals are:\n\nto assess the clinical impact of SeizureWise on quality of life (QoL), psychological health indicators, and economic and clinical outcomes to assess the clinical impact of visualizing behavioral and physiologic data without forecasting predictions on quality of life (QoL), psychological health indicators, and economic and clinical outcomes\n\nA non-significant risk, open-label, prospective, randomized clinical investigation designed to evaluate the ability of SeizureWise to forecast GTCS occurrence and to assess impact on QoL and seizure management outcomes.\n\nThe study will include two phases during which an algorithm based on sensor derived physiological measures is developed and tested with output blinded to the participant. In a final phase participants will be randomized to two arms, one of which will have access to a seizure forecasting risk score.",[19],"Epilepsy; Seizure",[21],"forecasting","INTERVENTIONAL","OTHER",[25],"NA",{"count":27,"type":28},3000,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","SeizureWise algorithm","An investigational algorithm which enables forecasting of future seizure probabilities based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables",[35],"Personalized seizure risk score",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Multi-day Visualizations","Multi-day visualizations of sensor derived data",[40,35],"Control",[42],{"measure":43,"description":44,"timeFrame":45},"Sensitivity of SeizureWise","Percentage of patients with (1) sensitivity of high-likelihood warnings greater than 60% and (2) superior to a rate-matched forecast (or superior baselining method) at the end of Phase 2.","2 years",[47,50,53,56,59,62],{"measure":48,"description":49,"timeFrame":45},"Change in QoL and psychological health indicators using the Quality of life in epilepsy (QOLIE-10-P)","Changes in QoL and psychological health indicators pre- and post-Phase 3 (cross-arm and intra-arm comparisons. This will be assessed using the QOLIE-10-P and scored according to these guidelines https:\u002F\u002Fwww.aan.com\u002Fsiteassets\u002Fhome-page\u002Fpolicy-and-guidelines\u002Fquality\u002Fquality-measures\u002Fepilepsy-and-seizures\u002Fqolie10p-scoring.pdf",{"measure":51,"description":52,"timeFrame":45},"Qualitative assessment of multi-day visualizations","Patient-reported qualitative assessment of multi-day visualizations to the patient during Phase 3 (both arms). This will be assessed using a custom survey and a qualitative analysis of the scores will be performed between start of phase 3 (with no visualizations) and during and at the end of phase 3 when visualizations have been provided to the user.",{"measure":54,"description":55,"timeFrame":45},"Stress level with visualizations using the brief epilepsy anxiety survey instrument (brEASI-8)","Quantitative patient report of stress level pre- and post- forecast visualization during Phase 3 in the intervention arm. This will be assessed using brEASI-8 where a lower score indicates a lower stress level.",{"measure":57,"description":58,"timeFrame":45},"Modifiable behavior change","Adjustment in modifiable behaviors during Phase 3 based on multi-day visualizations (boths arms) and forecast outputs (intervention arm). This will be assessed using a custom survey and a qualitative analysis will be performed that looks at participants behaviors before and after receiving visualizations and SeizureWise.",{"measure":60,"description":61,"timeFrame":45},"Accuracy of SeizureWise low-likelihood forecast","Percentage of time in a low-likelihood forecast category during which no seizure event occurs during Phase 2.",{"measure":63,"description":64,"timeFrame":45},"Accuracy of SeizureWise high-likelihood forecast","Percentage of time in a high-likelihood forecast category during which a seizure event occurs during Phase 2.","ALL","6 Years",null,{"inclusion":69,"exclusion":75,"raw_text":80},[70,71,72,73,74],"Subjects must be diagnosed with or be at risk of epilepsy","Subjects or their parents or guardians must understand and consent to be in the study;","Subjects or their parents or guardians must be able to read and communicate in English;","Subjects or their parents or guardians must be willing and able to comply with study procedures and duration;","Subjects must have a wrist circumference suitable for wearing the EmbracePlus device.",[76,77,78,79],"Subjects, or their parents or guardians for minor study participants, who do not understand the study and the risks;","Subjects, or their parents or guardians for minor study participants, who are either physically or cognitively incapable of performing study activities (e.g. filling in surveys and daily e-diary);","Subjects who would be placed at undue medical risk associated with any procedure called for in the protocol; or","Subjects that are Empatica employees and actively participated in the development of this protocol or development of the Seizure Wise algorithms.","Inclusion Criteria:\n\n* Subjects must be diagnosed with or be at risk of epilepsy\n* Subjects or their parents or guardians must understand and consent to be in the study;\n* Subjects or their parents or guardians must be able to read and communicate in English;\n* Subjects or their parents or guardians must be willing and able to comply with study procedures and duration;\n* Subjects must have a wrist circumference suitable for wearing the EmbracePlus device.\n\nExclusion Criteria:\n\n* Subjects, or their parents or guardians for minor study participants, who do not understand the study and the risks;\n* Subjects, or their parents or guardians for minor study participants, who are either physically or cognitively incapable of performing study activities (e.g. filling in surveys and daily e-diary);\n* Subjects who would be placed at undue medical risk associated with any procedure called for in the protocol; or\n* Subjects that are Empatica employees and actively participated in the development of this protocol or development of the Seizure Wise algorithms.",[82,83,84],"CHILD","ADULT","OLDER_ADULT",[86],{"facility":87,"status":8,"city":88,"state":89,"zip":90,"country":91,"contacts":92,"geoPoint":97},"Empatica","Boston","Massachusetts","02111","United States",[93],{"name":87,"role":94,"phone":95,"email":96},"CONTACT","855-830-3531","support@empatica.com",{"lat":98,"lon":99},42.35843,-71.05977,[101],{"name":102,"role":94,"phone":95,"email":96},"Empatica Support",[],[],[],{"nct_id":4,"conditions":107,"biomarkers":109},[108],"Seizure Disorder",[],{"nct_id":4,"found":111,"summary":112,"prompt_version":122},true,{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is an interventional study where participants will be randomly assigned to different groups. It is an open-label study, meaning both you and the researchers will know which intervention you are receiving.","completed","Forecasting Seizures Using Intelligent Wearable Technology","This study is testing a new tool called SeizureWise, which is an algorithm designed to predict future seizure probabilities. It uses information from your past generalized tonic-clonic seizures (GTCS) and changes in your body's signals and behaviors, collected by a wearable device. Researchers want to see if SeizureWise can accurately forecast seizures and if having access to this information improves the lives of people with epilepsy. You could join if you are 6 years or older, have epilepsy or are at risk, and can understand and agree to the study procedures. The study aims to enroll 3000 participants.","The primary outcome, the sensitivity of SeizureWise, will be measured at 2 years.",98,"You will use a wearable EmbracePlus device and provide data. The study will involve two phases where the algorithm is developed and tested, followed by a final phase where you might have access to a seizure forecasting risk score.","Not stated in the trial record.",[],"v2"]