Onchocerciasis-Associated Epilepsy, an Explorative Case-control Study
NCT ID: NCT05868551
Last Updated: 2023-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2023-06-01
2024-12-31
Brief Summary
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The 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.
In 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.
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Detailed Description
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In 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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Persons with onchocerciasis nodules with OAE and without epilepsy
nodulectomy to extract adult worms
nodulectomy
incision in an onchocerciasis nodule to extract adult worms
Interventions
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nodulectomy
incision in an onchocerciasis nodule to extract adult worms
Eligibility Criteria
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Inclusion Criteria
* Age 12-35 years old
* informed consent signed
* Living in Maridi County, Western Equatorial State, South Sudan
Exclusion Criteria
12 Years
35 Years
ALL
No
Sponsors
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Amref Health Africa
OTHER
Universiteit Antwerpen
OTHER
Responsible Party
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Robert Colebunders
Emeritus professor, head NSETHIO research group, Global Health institute
Principal Investigators
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Robert Colebunders, MD
Role: PRINCIPAL_INVESTIGATOR
Universiteit Antwerpen
Locations
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Amref Health Africa
Juba, Central, South Sudan
Countries
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Central Contacts
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References
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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.
Other Identifiers
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AID 011898
Identifier Type: -
Identifier Source: org_study_id
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