Nctid:
NCT06614400
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000083242", "term"=>"Ischemic Stroke"}], "ancestors"=>[{"id"=>"D020521", "term"=>"Stroke"}, {"id"=>"D002561", "term"=>"Cerebrovascular Disorders"}, {"id"=>"D001927", "term"=>"Brain Diseases"}, {"id"=>"D002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}, {"id"=>"D014652", "term"=>"Vascular Diseases"}, {"id"=>"D002318", "term"=>"Cardiovascular Diseases"}], "browseLeaves"=>[{"id"=>"M10543", "name"=>"Ischemia", "relevance"=>"LOW"}, {"id"=>"M22306", "name"=>"Stroke", "relevance"=>"LOW"}, {"id"=>"M2400", "name"=>"Ischemic Stroke", "asFound"=>"Ischemic Stroke", "relevance"=>"HIGH"}, {"id"=>"M5810", "name"=>"Cerebrovascular Disorders", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>18}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10-08", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-04-08", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-08-28", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-03-08", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Primary outcome", "timeFrame"=>"3 hours", "description"=>"a change in brain haemodynamics (or blood flow) in terms of oxygenated and de-oxygentated blood from baseline to end of study participation."}], "secondaryOutcomes"=>[{"measure"=>"Secondary objective", "timeFrame"=>"3 hours", "description"=>"Neurovascular coupling, Cerebral autoregulation and dynamic functional connectivity"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Ischaemic Stroke"]}, "descriptionModule"=>{"briefSummary"=>"The primary objective is to investigate in stroke patients the impact of geko™ NMES treatment, when used as standard of care for VTE prevention, on brain haemodynamics at different stimulation levels and in three different postural positions (supine, semi-supine \\[45° seated\\] and seated). The aim is to identify the optimal stimulation level and postural position for the maximum response (NMES versus no NMES) with regard to relative total haemoglobin concentration (i.e., the sum of relative deoxyhaemoglobin and oxyhaemoglobin concentrations) using fNIRS and EEG."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Adults (over 18 years) with ischaemic stroke more than 7 days from onset", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Adult over 18\n* Patient with ischaemic stroke diagnosis confirmed by a stroke physician.\n* No intracerebral haemorrhage as ruled out by computerised tomography (CT) or MRI scan.\n* Able to achieve a supine, sitting and semi-sitting position of 45° with the help of another person.\n* Receiving geko™ NMES treatment as standard of care for VTE prevention\n\nExclusion Criteria:\n\n* Inability to gain consent from the patient.\n* A transient ischaemic attack (TIA).\n* Stroke survivors with ischaemic stroke less than 7 days from onset.\n* History of epilepsy.\n* Below/above knee amputation.\n* History of established peripheral neuropathy.\n* Too unwell to participate as judged by physician.\n* Use of any other neuromodulation device that may interact with NMES"}, "identificationModule"=>{"nctId"=>"NCT06614400", "acronym"=>"RETRAIN", "briefTitle"=>"The RETRAIN Trial (Phase 1)", "organization"=>{"class"=>"OTHER", "fullName"=>"Countess of Chester NHS Foundation Trust"}, "officialTitle"=>"MonitoRing the Effect of TRAnscutaneous Functional ElectrIcal Stimulation of the Common Peroneal Nerve on Cerebral Haemodynamics in Patients with Ischaemic Strokes. a Single Centre Prospective Study (Phase 1).", "orgStudyIdInfo"=>{"id"=>"343056"}}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"CH2 1UL", "city"=>"Chester", "state"=>"Cheshire", "country"=>"United Kingdom", "contacts"=>[{"name"=>"Jude Prince", "role"=>"CONTACT", "email"=>"jude.prince@nhs.net", "phone"=>"01244 365000", "phoneExt"=>"5243"}, {"name"=>"Kausik Chatterjee", "role"=>"CONTACT", "email"=>"Kausik.chatterjee@nhs.net", "phone"=>"01244 365000", "phoneExt"=>"6157"}, {"name"=>"Kausik Chatterjee", "role"=>"CONTACT"}], "facility"=>"Countess of Chester Hospital NHS Foundation Trust", "geoPoint"=>{"lat"=>53.1905, "lon"=>-2.89189}}], "centralContacts"=>[{"name"=>"Jude Prince", "role"=>"CONTACT", "email"=>"jude.prince@nhs.net", "phone"=>"012-443-65000", "phoneExt"=>"5243"}, {"name"=>"Kausik Chatterjee", "role"=>"CONTACT", "email"=>"kausik.chatterjee@nhs.net", "phone"=>"012-4436-5000", "phoneExt"=>"6157"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED", "description"=>"No identifiable patient data will be shared, only the findings of the procedure."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Countess of Chester NHS Foundation Trust", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
