Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-20 @ 8:14 PM
Study NCT ID:
NCT05868551
Status:
UNKNOWN
Last Update Posted:
2023-05-22
First Post:
2023-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Onchocerciasis-Associated Epilepsy, an Explorative Case-control Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D009855', 'term': 'Onchocerciasis'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005368', 'term': 'Filariasis'}, {'id': 'D017205', 'term': 'Spirurida Infections'}, {'id': 'D017190', 'term': 'Secernentea Infections'}, {'id': 'D009349', 'term': 'Nematode Infections'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D012876', 'term': 'Skin Diseases, Parasitic'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'skin snips O.volvulus worms'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-17', 'studyFirstSubmitDate': '2023-05-08', 'studyFirstSubmitQcDate': '2023-05-17', 'lastUpdatePostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The O. volvulus virome of persons with onchocerciasis-associated epilepsy (OAE) and of persons with onchocerciasis but without epilepsy', 'timeFrame': '1 day', 'description': 'The type of virusses present in the O. volvulus worm present in the nodules of persons with OAE and in nodules of persons without epilepsy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Onchocerciasis', 'Epilepsy', 'metagenomics', 'South Sudan', 'Pathogenesis'], 'conditions': ['Onchocercal Subcutaneous Nodule', 'Epilepsy', 'Virus']}, 'referencesModule': {'references': [{'pmid': '38439783', 'type': 'DERIVED', 'citation': 'Hadermann A, Jada SR, Sebit WJ, Deng T, Bol YY, Siewe Fodjo JN, De Coninck L, Matthijnssens J, Mertens I, Polman K, Colebunders R. Onchocerciasis-associated epilepsy: an explorative case-control study with viral metagenomic analyses on Onchocerca volvulus. F1000Res. 2023 Dec 11;12:1262. doi: 10.12688/f1000research.138774.2. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'This is an exploratory case control study with the aim to compare the Onchocerca volvulus virome between persons with onchocerciasis-associated epilepsy (OAE) and persons with onchocerciasis but without epilepsy.\n\nThe main question we want to address is: Is there a virus contained in the O. volulus worm that may have a pathogenic role in causing OAE.\n\nIn Maridi County, South Sudan, 20 persons with OAE with onchocerciasis nodules, and 20 age- and village-matched controls without OAE will be enrolled in a nodulectomy study.The adult O. volvulus worms will be extracted from the nodules and a viral metagenomic study of the worms. The O. volvulus virome of persons with and without OAE will be compared.', 'detailedDescription': 'A high prevalence of onchocerciasis-associated epilepsy (OAE) has been observed in onchocerciasis-endemic areas with high ongoing Onchocerca volvulus transmission. However, the pathogenesis of OAE remains to be elucidated. We hypothesise that the O. volvulus virome could be involved in inducing epilepsy. With this study, we aim to describe the O. volvulus virome and identify possible viruses linked to OAE.\n\nIn Maridi County, South Sudan, 20 persons with OAE with onchocerciasis nodules, and 20 age- and village-matched controls without OAE will be enrolled in the study. For each study participant, two skin snips at the iliac crest will be obtained to collect O. volvulus microfilaria, and one nodulectomy will be performed to obtain adult worms. A viral metagenomic study will be conducted on microfilariae and adult worms, and the O. volvulus virome of persons with and without OAE will be compared. Moreover, the prevalence, numbers and localisation of onchocerciasis nodules in persons with and without OAE in villages with a high prevalence of epilepsy in Maridi will be described.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cases: persons with onchocerciasis nodules and OAE Controls: persons with onchocerciasis nodules without epilepsy', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Onchocerciasis nodules\n* Age 12-35 years old\n* informed consent signed\n* Living in Maridi County, Western Equatorial State, South Sudan\n\nExclusion Criteria:\n\n* below the age of 12'}, 'identificationModule': {'nctId': 'NCT05868551', 'briefTitle': 'Onchocerciasis-Associated Epilepsy, an Explorative Case-control Study', 'organization': {'class': 'OTHER', 'fullName': 'Universiteit Antwerpen'}, 'officialTitle': 'Onchocerciasis-Associated Epilepsy, an Explorative Case-control Study With Viral Metagenomic Analysis of Onchocerca Volvulus.', 'orgStudyIdInfo': {'id': 'AID 011898'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Persons with onchocerciasis nodules with OAE and without epilepsy', 'description': 'nodulectomy to extract adult worms', 'interventionNames': ['Procedure: nodulectomy']}], 'interventions': [{'name': 'nodulectomy', 'type': 'PROCEDURE', 'description': 'incision in an onchocerciasis nodule to extract adult worms', 'armGroupLabels': ['Persons with onchocerciasis nodules with OAE and without epilepsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '140', 'city': 'Juba', 'state': 'Central', 'country': 'South Sudan', 'facility': 'Amref Health Africa', 'geoPoint': {'lat': 4.85165, 'lon': 31.58247}}], 'centralContacts': [{'name': 'Robert Colebunders, MD', 'role': 'CONTACT', 'email': 'robert.colebunders@uantwerpen.be', 'phone': '+32486920149'}, {'name': 'Jean Pierre Van geertruyden, MD', 'role': 'CONTACT', 'email': 'jean-pierre.vangeertruyden@uantwerpen.be', 'phone': '+32651800'}], 'overallOfficials': [{'name': 'Robert Colebunders, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiteit Antwerpen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'After de-identification (text, tables, figures, and appendices), all individual participant data underlying the results reported in this article will be made available immediately and indefinitely via the Zenodo repository following publication for anyone who wishes to access the data for any purpose.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiteit Antwerpen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amref Health Africa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Emeritus professor, head NSETHIO research group, Global Health institute', 'investigatorFullName': 'Robert Colebunders', 'investigatorAffiliation': 'Universiteit Antwerpen'}}}}