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NCT05868551 | Not yet recruiting | Onchocercal Subcutaneous Nodule


Onchocerciasis-Associated Epilepsy, an Explorative Case-control Study
Sponsor:

Universiteit Antwerpen

Information provided by (Responsible Party):

Robert Colebunders

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.

Condition or disease

Onchocercal Subcutaneous Nodule

Epilepsy

Virus

Intervention/treatment

nodulectomy

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.

Study Type : Observational
Estimated Enrollment : 40 participants
Official Title: Onchocerciasis-Associated Epilepsy, an Explorative Case-control Study With Viral Metagenomic Analysis of Onchocerca Volvulus.
Actual Study Start Date : June 1, 2023
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : December 31, 2024

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 12 Years to 35 Years
Sexes Eligible for Study: All
Criteria
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

Onchocerciasis-Associated Epilepsy, an Explorative Case-control Study

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Onchocerciasis-Associated Epilepsy, an Explorative Case-control Study

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Locations


Not yet recruiting

South Sudan, Central

Amref Health Africa

Juba, Central, South Sudan, 140

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