Onchocerciasis-Associated Epilepsy, an Explorative Case-control Study

Sponsor

Universiteit Antwerpen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05868551

Collaborator

Amref Health Africa (Other)

Enrollment

Location

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Onchocercal Subcutaneous Nodule Epilepsy Virus	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

40 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 35 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amref Health Africa	Juba	Central	South Sudan	140

Sponsors and Collaborators

Universiteit Antwerpen
Amref Health Africa

Investigators

Principal Investigator: Robert Colebunders, MD, Universiteit Antwerpen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Robert Colebunders, Emeritus professor, head NSETHIO research group, Global Health institute, Universiteit Antwerpen

ClinicalTrials.gov Identifier:

NCT05868551

Other Study ID Numbers:

AID 011898

First Posted:

May 22, 2023

Last Update Posted:

May 22, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Robert Colebunders, Emeritus professor, head NSETHIO research group, Global Health institute, Universiteit Antwerpen

Additional relevant MeSH terms:

Onchocerciasis

Epilepsy

Study Results

No Results Posted as of May 22, 2023