Nctid:
NCT06615622
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000010523", "term"=>"Peripheral Nervous System Diseases"}, {"id"=>"D000020275", "term"=>"Guillain-Barre Syndrome"}, {"id"=>"D000011129", "term"=>"Polyradiculoneuropathy"}, {"id"=>"D000020277", "term"=>"Polyradiculoneuropathy, Chronic Inflammatory Demyelinating"}], "ancestors"=>[{"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000009468", "term"=>"Neuromuscular Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000020274", "term"=>"Autoimmune Diseases of the Nervous System"}, {"id"=>"D000003711", "term"=>"Demyelinating Diseases"}, {"id"=>"D000011115", "term"=>"Polyneuropathies"}, {"id"=>"D000001327", "term"=>"Autoimmune Diseases"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}, {"id"=>"D000094025", "term"=>"Post-Infectious Disorders"}, {"id"=>"D000002908", "term"=>"Chronic Disease"}, {"id"=>"D000020969", "term"=>"Disease Attributes"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M22095", "name"=>"Guillain-Barre Syndrome", "asFound"=>"Guillain-Barre Syndrome", "relevance"=>"HIGH"}, {"id"=>"M13432", "name"=>"Peripheral Nervous System Diseases", "asFound"=>"Peripheral Nerve Disorder", "relevance"=>"HIGH"}, {"id"=>"M14013", "name"=>"Polyradiculoneuropathy", "asFound"=>"Polyradiculoneuropathy", "relevance"=>"HIGH"}, {"id"=>"M22097", "name"=>"Polyradiculoneuropathy, Chronic Inflammatory Demyelinating", "asFound"=>"Chronic Inflammatory Demyelinating Polyradiculoneuropathy", "relevance"=>"HIGH"}, {"id"=>"M12411", "name"=>"Neuromuscular Diseases", "relevance"=>"LOW"}, {"id"=>"M22094", "name"=>"Autoimmune Diseases of the Nervous System", "relevance"=>"LOW"}, {"id"=>"M4629", "name"=>"Autoimmune Diseases", "relevance"=>"LOW"}, {"id"=>"M6909", "name"=>"Demyelinating Diseases", "relevance"=>"LOW"}, {"id"=>"M13999", "name"=>"Polyneuropathies", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M3014", "name"=>"Post-Infectious Disorders", "relevance"=>"LOW"}, {"id"=>"M6147", "name"=>"Chronic Disease", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}, {"id"=>"T170", "name"=>"Acute Graft Versus Host Disease", "relevance"=>"LOW"}, {"id"=>"T2640", "name"=>"Guillain-Barre Syndrome", "asFound"=>"Guillain-Barre Syndrome", "relevance"=>"HIGH"}, {"id"=>"T1306", "name"=>"Chronic Inflammatory Demyelinating Polyneuropathy", "asFound"=>"Chronic Inflammatory Demyelinating Polyradiculoneuropathy", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"bioSpec"=>{"retention"=>"SAMPLES_WITHOUT_DNA", "description"=>"Serum samples CSF samples"}, "studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"CASE_CONTROL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>90}, "targetDuration"=>"6 Months", "patientRegistry"=>true}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-09-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2028-03-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-19", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2027-03-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Detection of Nerve Alterations via Ultrasound", "timeFrame"=>"6 months", "description"=>"* Determine if patients with acute GBS and CIDP exhibit nerve alterations detectable by ultrasound that are comparable to electrodiagnostic findings.\n* Assess the utility of ultrasound in diagnosing GBS and CIDP in the very early phase of the disease."}], "secondaryOutcomes"=>[{"measure"=>"Evaluation of Nerve Morphology Evolution", "timeFrame"=>"6 months", "description"=>"* Investigate patterns of nerve morphology through nerve ultrasound studies in GBS and CIDP patients over the course of the disease.\n* Compare these patterns with serial NCS findings."}, {"measure"=>"Prediction of Outcomes and Recovery", "timeFrame"=>"6 months", "description"=>"- Evaluate the potential of nerve ultrasound changes as predictors of clinical outcomes and recovery in GBS and CIDP patients."}, {"measure"=>"Differentiation of Subtypes", "timeFrame"=>"6 months", "description"=>"- Assess if early nerve ultrasound changes can differentiate between axonal and demyelinating subtypes of GBS and CIDP."}, {"measure"=>"Correlation with Clinical Scales", "timeFrame"=>"6 months", "description"=>"- Correlate ultrasound findings with clinical scales and outcomes, such as the Guillain-Barré Syndrome Disability Scale (GDS), Medical Research Council Sum Score (MRC sum score), and Erasmus GBS Outcome Scale (EGOS)"}, {"measure"=>"Comparison with Healthy Controls", "timeFrame"=>"6 months", "description"=>"- Compare the ultrasound parameters of GBS and CIDP patients with age and sex-matched healthy controls to identify significant differences in nerve morphology"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Peripheral nerve ultrasound", "immune mediated nerve disorders", "Guillain-Barré syndrome", "Chronic inflammatory demyelinating polyradiculoneuropathy"], "conditions"=>["Guillain Barré Syndrome", "Chronic Inflammatory Demyelinating Polyradiculoneuropathy", "Peripheral Nerve Disorder", "Peripheral Nerves US", "Peripheral Neuropathy"]}, "referencesModule"=>{"references"=>[{"pmid"=>"17337484", "type"=>"BACKGROUND", "citation"=>"Hughes RA, Swan AV, Raphael JC, Annane D, van Koningsveld R, van Doorn PA. Immunotherapy for Guillain-Barre syndrome: a systematic review. Brain. 2007 Sep;130(Pt 9):2245-57. doi: 10.1093/brain/awm004. Epub 2007 Mar 2."}, {"pmid"=>"14973982", "type"=>"BACKGROUND", "citation"=>"Hughes RA, Raphael JC, Swan AV, Doorn PA. Intravenous immunoglobulin for Guillain-Barre syndrome. Cochrane Database Syst Rev. 2004;(1):CD002063. doi: 10.1002/14651858.CD002063.pub2."}, {"pmid"=>"25238327", "type"=>"BACKGROUND", "citation"=>"Hughes RA, Swan AV, van Doorn PA. Intravenous immunoglobulin for Guillain-Barre syndrome. Cochrane Database Syst Rev. 2014 Sep 19;2014(9):CD002063. doi: 10.1002/14651858.CD002063.pub6."}, {"pmid"=>"25023340", "type"=>"BACKGROUND", "citation"=>"van den Berg B, Walgaard C, Drenthen J, Fokke C, Jacobs BC, van Doorn PA. Guillain-Barre syndrome: pathogenesis, diagnosis, treatment and prognosis. Nat Rev Neurol. 2014 Aug;10(8):469-82. doi: 10.1038/nrneurol.2014.121. Epub 2014 Jul 15."}, {"pmid"=>"26948435", "type"=>"BACKGROUND", "citation"=>"Willison HJ, Jacobs BC, van Doorn PA. Guillain-Barre syndrome. Lancet. 2016 Aug 13;388(10045):717-27. doi: 10.1016/S0140-6736(16)00339-1. Epub 2016 Mar 2."}, {"pmid"=>"9781538", "type"=>"BACKGROUND", "citation"=>"Jacobs BC, Rothbarth PH, van der Meche FG, Herbrink P, Schmitz PI, de Klerk MA, van Doorn PA. The spectrum of antecedent infections in Guillain-Barre syndrome: a case-control study. Neurology. 1998 Oct;51(4):1110-5. doi: 10.1212/wnl.51.4.1110."}, {"pmid"=>"35256276", "type"=>"BACKGROUND", "citation"=>"Laman JD, Huizinga R, Boons GJ, Jacobs BC. Guillain-Barre syndrome: expanding the concept of molecular mimicry. Trends Immunol. 2022 Apr;43(4):296-308. doi: 10.1016/j.it.2022.02.003. Epub 2022 Mar 4."}, {"pmid"=>"21422765", "type"=>"BACKGROUND", "citation"=>"Sejvar JJ, Baughman AL, Wise M, Morgan OW. Population incidence of Guillain-Barre syndrome: a systematic review and meta-analysis. Neuroepidemiology. 2011;36(2):123-33. doi: 10.1159/000324710. Epub 2011 Mar 21."}]}, "descriptionModule"=>{"briefSummary"=>"Neuromuscular ultrasound (NMUS) is emerging as a valuable non-invasive diagnostic tool. In GBS, NMUS can detect proximal nerve enlargement early, before neurophysiological changes. Persistent nerve enlargement can be observed up to 15 years, though its correlation with disability varies. Research is needed to clarify NMUS findings in GBS and CIDP over time. Early detection of nerve root enlargement via NMUS could facilitate earlier diagnosis and intervention, improving patient outcomes and understanding of these conditions\\' pathophysiology.\n\nThis study aims to determine if nerve alterations in acute GBS and CIDP detectable by ultrasound match electrodiagnostic findings and if this method aids early diagnosis. The investigators will perform serial nerve ultrasounds and NCS to investigate nerve morphology, predict outcomes, and differentiate between axonal and demyelinating subtypes."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"A hospital-based study. Patients who are admitted to Assiut university hospitals, neuropsychiatry department.", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Diagnosis of patient group:\n\n * GBS Patients: Diagnosed according to the criteria of the National Institute of Neurological Disorders and Stroke (NINDS) and the Brighton Collaboration (2011).\n * CIDP Patients: Diagnosed according to the criteria of the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS).\n2. Age: Participants aged 18 to 75 years.\n3. Onset:\n\n * GBS Patients: Recent onset of GBS within the first 2 weeks of symptom onset.\n * CIDP Patients: Either relapsing or progressive course consistent with CIDP diagnosis.\n4. Gender: Both male and female participants are eligible.\n5. Participation: Willingness to participate in the study, including undergoing disease-related examinations and assessments.\n6. Consent: Ability and willingness to provide informed consent\n\nExclusion Criteria:\n\n1. Patients unable or unwilling to provide informed consent.\n2. Patients with metabolic disorders or malignancies.\n3. Patients with other causes of peripheral neuropathy.\n4. Patients with other causes of acute flaccid paralysis."}, "identificationModule"=>{"nctId"=>"NCT06615622", "briefTitle"=>"Our Study Aims to Determine If Nerve Alterations in Acute GBS and CIDP Detectable by Ultrasound Match Electrodiagnostic Findings and If This Method Aids Early Diagnosis, Predict Their Outcomes and Differentiate Between Axonal and Demyelinating Subtypes.", "organization"=>{"class"=>"OTHER", "fullName"=>"Assiut University"}, "officialTitle"=>"A Comparative Study of Peripheral Nerve Ultrasound Findings in Immune Mediated Peripheral Nerve Disorders; a Hospital-based Study", "orgStudyIdInfo"=>{"id"=>"04-2024-200877"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Case", "description"=>"Patients with immune mediated peripheral nerve disorders GB syndrome and CIDP", "interventionNames"=>["Dietary Supplement: Placebo"]}, {"label"=>"Control", "description"=>"Healthy control matching group", "interventionNames"=>["Dietary Supplement: Placebo"]}], "interventions"=>[{"name"=>"Placebo", "type"=>"DIETARY_SUPPLEMENT", "description"=>"Thiotacid 300 mg tab once/day", "armGroupLabels"=>["Case", "Control"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Assiut", "status"=>"RECRUITING", "country"=>"Egypt", "contacts"=>[{"name"=>"Vice president of graduate studies of Assiut University", "role"=>"CONTACT", "email"=>"vp_grad@aun.edu.eg", "phone"=>"+2088 22080150"}], "facility"=>"Assiut University Hospitals", "geoPoint"=>{"lat"=>27.18096, "lon"=>31.18368}}], "centralContacts"=>[{"name"=>"Mohammed Gad Ibrahim, MB, BCh", "role"=>"CONTACT", "email"=>"modyurd222@gmail.com", "phone"=>"+201022748859", "phoneExt"=>"1022748859"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Assiut University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Mohammed Gad Ibrahim Farghly", "investigatorAffiliation"=>"Assiut University"}}}}
