Onchocerciasis-Associated Epilepsy, an Explorative Case-control Study

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05868551
• Other study ID #: AID 011898
• Status: Not yet recruiting
• Start date: June 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Universiteit Antwerpen
• Contact: Robert Colebunders, MD
• Phone: +32486920149
• Email: robert.colebunders[@]uantwerpen.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: July 1, 2024
• Gender: All
• Age group: 12 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Onchocerciasis
• Virus

Intervention

Procedure:
• nodulectomy
incision in an onchocerciasis nodule to extract adult worms

Locations

Country	Name	City	State
South Sudan	Amref Health Africa	Juba	Central

Sponsors (2)

Lead Sponsor	Collaborator
Universiteit Antwerpen	Amref Health Africa

Country where clinical trial is conducted

South Sudan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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