Onchocerciasis-Associated Epilepsy, an Explorative Case-control Study

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Epilepsy; Virus; Onchocercal Subcutaneous Nodule
• Intervention / Treatment: Procedure: 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
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Robert Colebunders, MD; Phone Number: +32486920149; Email: robert.colebunders@uantwerpen.be
• Study Contact Backup: Name: Jean Pierre Van geertruyden, MD; Phone Number: +32651800; Email: jean-pierre.vangeertruyden@uantwerpen.be

Study Locations

• South Sudan
  • Central
    • Juba, Central, South Sudan, 140
      • Amref Health Africa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Cases: persons with onchocerciasis nodules and OAE Controls: persons with onchocerciasis nodules without epilepsy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Persons with onchocerciasis nodules with OAE and without epilepsy; nodulectomy to extract adult worms	Procedure: nodulectomy; incision in an onchocerciasis nodule to extract adult worms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The O. volvulus virome of persons with onchocerciasis-associated epilepsy (OAE) and of persons with onchocerciasis but without epilepsy	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	1 day

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen
• Collaborators: Amref Health Africa
• Investigators: Principal Investigator: Robert Colebunders, MD, Universiteit Antwerpen

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Epilepsy; Pathogenesis; Onchocerciasis; metagenomics; South Sudan
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Infections; Parasitic Diseases; Skin Diseases, Parasitic; Skin Diseases, Infectious; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Filariasis; Epilepsy; Onchocerciasis
• Other Study ID Numbers: AID 011898

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: After de-identification (text, tables, figures, and appendices), all individual participant data underlying the results reported in this article will be made available immediately and indefinitely via the Zenodo repository following publication for anyone who wishes to access the data for any purpose.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No