Onchocerciasis-Associated Epilepsy, an Explorative Case-control Study

Not yet recruiting

• Conditions: Onchocercal Subcutaneous Nodule; Epilepsy; Virus
• Interventions: Procedure: nodulectomy

• Registration Number: NCT05868551
• Lead Sponsor: Universiteit Antwerpen

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.

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-17
• Last Update Submitted: 2023-05-17
• Study First Posted: 2023-05-22
• Last Update Posted: 2023-05-22
• Study Start: 2023-06-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Persons with onchocerciasis nodules with OAE and without epilepsy	nodulectomy	nodulectomy to extract adult worms

Primary Outcome Measures

Name	Time	Method
The O. volvulus virome of persons with onchocerciasis-associated epilepsy (OAE) and of persons with onchocerciasis but without epilepsy	1 day	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

Trial Locations

Locations (1)

Amref Health Africa; 🇸🇸 Juba, Central, South Sudan