Clinical trial NCT05868551: Onchocerciasis-Associated Epilepsy, an Explorative Case-control Study
Official title: Onchocerciasis-Associated Epilepsy, an Explorative Case-control Study With Viral Metagenomic Analysis of Onchocerca Volvulus.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Onchocercal Subcutaneous Nodule
Epilepsy
Virus
Keywords: Onchocerciasis
Epilepsy
metagenomics
South Sudan
Pathogenesis
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: Amref Health Africa
First posted: 2023-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases: persons with onchocerciasis nodules and OAE Controls: persons with onchocerciasis nodules without epilepsy

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.

Eligibility 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

Primary outcomes:
measure: The O. volvulus virome of persons with onchocerciasis-associated epilepsy (OAE) and of persons with onchocerciasis but without epilepsy
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Juba
country: South Sudan
facility: Amref Health Africa
state: Central
Study officials:
affiliation: Universiteit Antwerpen
name: Robert Colebunders, MD
role: PRINCIPAL_INVESTIGATOR
References: