[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502003":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":61,"studyPopulation":49,"armGroups":62,"interventions":75,"overallOfficials":85,"centralContacts":89,"locations":95,"responsibleParty":113,"collaborators":115,"id":118,"slug":49,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":49,"eligibilityCriteria":123,"healthyVolunteers":119,"sex":124,"minAge":125,"maxAge":49,"enrollmentInfo":126,"targetDuration":49,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":49,"overallStatus":98,"whyStopped":49,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Weill Medical College of Cornell University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":49},[9],{"measure":10,"description":11,"timeFrame":12},"Mean change from baseline Fatigue Severity Scale - 7 (FSS-7)","Fatigue Severity. This seven item scale measures fatigue severity and it's effect on a person's lifestyle and activities. Items are scored on a seven point scale. Minimum score = 7, maximum score = 49 with higher score indicating greater fatigue severity.","Screening (-1 to -14 days), Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52))",[14,18,22,25,28,32,35,38,42,45],{"measure":15,"description":16,"timeFrame":17},"Mean change from baseline Stroke Specific Quality Of Life scale (SS-QOL)","Quality of Life. Assesses health related quality of life, specific to individuals with stroke. Composed of 49 items, score on a 5 point guttman type scale. Scores range from 49 to 245, with higher score indicating better functioning.","Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)",{"measure":19,"description":20,"timeFrame":21},"Mean change from baseline Patient Health Questionnaire - 9 (PHQ-9)","Depression. A multipurpose instrument for screening, measuring, and monitoring severity of depression. Scores range from 0-27, with higher score indicating greater severity of depression.","Screening (-1 to -14 days), Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)",{"measure":23,"description":24,"timeFrame":21},"Mean change from baseline Generalized Anxiety Disorder - 7 (GAD-7)","Anxiety. A multipurpose instrument for screening, measuring, and monitoring severity of anxiety. Scores range from 0-21, with higher score indicating greater severity of anxiety.",{"measure":26,"description":27,"timeFrame":17},"Mean change from baseline PROMIS-sleep disturbance","Sleep. A domain focused self report of global, physical, mental, and social health for those living with a chronic condition. Computer adapted test with higher scores indicating more sleep disturbance. Results reported as a T-score with range from 10-90 based on the United States general population average score of 50 and standard deviation of 10. Higher t-score indicates greater sleep disturbance.",{"measure":29,"description":30,"timeFrame":31},"Mean change from baseline Symbol Digit Modalities Test (SDMT)","Cognition. A measure of cognitive processing speed and attention. Scores range from 0-120, with higher scores better performance.","Baseline (Day 1), Post-Treatment (Day 14-21)",{"measure":33,"description":34,"timeFrame":31},"Mean change from baseline Test of Variables of Attention (T.O.V.A)","Cognition. A computerized test that measures short-term memory, with scores from 85-115 indicating a normal result. Response time, response time variability, commissions, and omissions are also recorded. A higher total number correct score indicates better performance.",{"measure":36,"description":37,"timeFrame":31},"Mean change from baseline Montreal cognitive assessment (MoCA)","Cognition. A brief screening tool to assess global cognitive functioning and detect mild cognitive dysfunction. Scored from 0-30 with higher score indicating better performance.",{"measure":39,"description":40,"timeFrame":41},"Mean Client Satisfaction Questionnaire - 8 (CSQ-8)","Feasibility. This tool is a self-report measure participant satisfaction with the intervention. Scored 8-32 with higher scores indicating greater satisfaction.","During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)",{"measure":43,"description":44,"timeFrame":17},"Mean change from baseline Frenchay activities index","Activities of Daily Living (ADLs). A measure of instrumental ADLs (domestic chores, leisure\u002Fwork, outdoor activities) for individuals recovering from stroke. Scored from 15-60 with higher score indicating improved functioning.",{"measure":46,"description":47,"timeFrame":48},"Change in resting state brain functional connectivity.","Change in functional connectivity in the active vs. the sham arms assessed by a resting state functional magnetic resonance imaging scan (rs-fMRI).","Baseline (Day 1), Post-treatment (Day 14-21)",null,{"allocation":51,"interventionModel":52,"interventionModelDescription":49,"primaryPurpose":53,"observationalModel":49,"timePerspective":49,"maskingInfo":54},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":55,"maskingDescription":49,"whoMasked":56},"QUADRUPLE",[57,58,59,60],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","The purpose of this study is to investigate transcranial direct current stimulation (tDCS) as a home-based non-pharmacologic intervention for post-stroke fatigue (PSF). Investigators will perform a double-blind, sham-controlled, randomized clinical trial with 24 subjects; 12 will receive sham stimulation and 12 will receive real stimulation. After a baseline assessment, the tDCS device will be applied for 20 minutes, once daily over the left dorsolateral prefrontal cortex (DLPFC), for a total of two weeks. Follow-up assessments with outcome metrics will be completed after the seventh and fourteenth sessions, and one-month following the start date (2 weeks post-treatment). Neuroimaging will be completed at baseline and post-treatment.",[63,69],{"label":64,"type":65,"description":66,"interventionNames":67},"Real tDCS stimulation","EXPERIMENTAL","Subjects randomized to receive real\u002Factive electrical stimulation.",[68],"Device: Real Soterix Mini-CT tDCS stimulator",{"label":70,"type":71,"description":72,"interventionNames":73},"Sham tDCS stimulation","SHAM_COMPARATOR","Subjects randomized to receive sham\u002Fnon-activating electrical stimulation.",[74],"Device: Sham Soterix Mini-CT tDCS stimulator",[76,81],{"type":77,"name":78,"description":79,"armGroupLabels":80,"otherNames":49},"DEVICE","Real Soterix Mini-CT tDCS stimulator","Real transcranial electrical stimulation at 2mA intensity will be delivered to the left dorsolateral prefrontal cortex, 20 minutes\u002Fday, 14-day duration.",[64],{"type":77,"name":82,"description":83,"armGroupLabels":84,"otherNames":49},"Sham Soterix Mini-CT tDCS stimulator","Sham stimulation to the left dorsolateral prefrontal cortex, 20 minutes\u002Fday, 14-day duration. The device will ramp up and ramp down current delivery from 0 mA -2 mA - 0 mA over 30 seconds at the start of the 20-minute protocol with no active stimulation until the end of the 20 minutes, at which time the 30-second ramp up\u002Framp down will be repeated.",[70],[86],{"name":87,"affiliation":5,"role":88},"Joan M Stilling, MD, MS","PRINCIPAL_INVESTIGATOR",[90],{"name":91,"role":92,"phone":93,"phoneExt":49,"email":94},"Zhiyan Yang, M.A.","CONTACT","(212) 746-1509","rehabresearch@med.cornell.edu",[96],{"facility":97,"status":98,"city":99,"state":99,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":109},"Weill Cornell Medicine, 525 E. 68th St, Baker Pavilion, F-2106","RECRUITING","New York","10065","United States","US",{"type":104,"coordinates":105},"Point",[106,107],-74.00597,40.71427,{"lat":107,"lon":106},[110,111],{"name":91,"role":92,"phone":93,"phoneExt":49,"email":94},{"name":112,"role":88,"phone":49,"phoneExt":49,"email":49},"Joan Stilling, MD, MS",{"type":114,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR",[116],{"name":117,"class":6},"American Heart Association","100502003",false,"NCT05816603","Transcranial Direct Current Stimulation for Post-stroke Fatigue","Home-based Post-stroke Fatigue Treatment Using Transcranial Direct Current Stimulation (tDCS)","Inclusion Criteria:\n\n* Male or female patients aged \\>18 years\n* Greater than 3 months from first hemorrhagic or ischemic stroke (subacute to chronic), confirmed through neuroimaging (CT or MRI).\n* Fatigue severity score average \\>4 (severe fatigue)\n* Willingness to remain stable on pharmacologic therapy through the duration of the study.\n* Availability of a caregiver, family member, or friend to be present during the administration of the tDCS intervention.\n\nExclusion Criteria:\n\n* Metal in the head (except mouth) or implanted cranial or thoracic devices (i.e. pacemaker, DBS stimulator)\n* History of seizure\n* History of moderate to severe traumatic brain injury\n* A score of 10 or more on the PHQ-9 or GAD-7 scale, suggestive of moderate to severe depression\u002Fanxiety.\n* A score of less than 21 on the MoCA suggesting major neurocognitive disorder.\n* Signs of skin rash, infection, or laceration in the supraorbital region where the tDCS will be applied.\n* Inability to provide informed consent\n* Other major neurological, medical, or psychiatric illnesses that could confound results in the opinion of the site investigator.","ALL","18 Years",{"count":127,"type":128},24,"ESTIMATED","INTERVENTIONAL",[131],"PHASE2","The investigators hypothesize that delivery of anodal tDCS to the left frontal head region will reduce fatigue severity following stroke.",[134,135],"Fatigue","Stroke Rehabilitaion","2026-02-24",{"date":138,"type":139},"2026-02-27","ACTUAL",{"date":141,"type":139},"2023-05-23",{"date":143,"type":128},"2027-12",{"name":5,"class":6},1]