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Onchocerciasis-Associated Epilepsy, an Explorative Case-control Study

Onchocerciasis-Associated Epilepsy, an Explorative Case-control Study With Viral Metagenomic Analysis of Onchocerca Volvulus.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05868551
Enrollment
40
Registered
2023-05-22
Start date
2023-06-01
Completion date
2024-12-31
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Onchocercal Subcutaneous Nodule, Virus

Keywords

Onchocerciasis, Epilepsy, metagenomics, South Sudan, Pathogenesis

Brief summary

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. 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.

Detailed description

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. 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.

Interventions

PROCEDUREnodulectomy

incision in an onchocerciasis nodule to extract adult worms

Sponsors

Amref Health Africa
CollaboratorOTHER
Universiteit Antwerpen
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
12 Years to 35 Years

Inclusion criteria

* Onchocerciasis nodules * Age 12-35 years old * informed consent signed * Living in Maridi County, Western Equatorial State, South Sudan

Exclusion criteria

* below the age of 12

Design outcomes

Primary

MeasureTime frameDescription
The O. volvulus virome of persons with onchocerciasis-associated epilepsy (OAE) and of persons with onchocerciasis but without epilepsy1 dayThe type of virusses present in the O. volvulus worm present in the nodules of persons with OAE and in nodules of persons without epilepsy

Countries

South Sudan

Contacts

Primary ContactRobert Colebunders, MD
robert.colebunders@uantwerpen.be+32486920149
Backup ContactJean Pierre Van geertruyden, MD
jean-pierre.vangeertruyden@uantwerpen.be+32651800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026