Onchocerciasis-Associated Epilepsy, an Explorative Case-control Study
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2023
CompletedFirst Posted
Study publicly available on registry
May 22, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMay 22, 2023
May 1, 2023
1.1 years
May 8, 2023
May 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Persons with onchocerciasis nodules with OAE and without epilepsy
nodulectomy to extract adult worms
Interventions
incision in an onchocerciasis nodule to extract adult worms
Eligibility Criteria
Cases: persons with onchocerciasis nodules and OAE Controls: persons with onchocerciasis nodules without epilepsy
You may qualify if:
- Onchocerciasis nodules
- Age 12-35 years old
- informed consent signed
- Living in Maridi County, Western Equatorial State, South Sudan
You may not qualify if:
- below the age of 12
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universiteit Antwerpenlead
- Amref Health Africacollaborator
Study Sites (1)
Amref Health Africa
Juba, Central, 140, South Sudan
Related Publications (1)
Hadermann A, Jada SR, Sebit WJ, Deng T, Bol YY, Siewe Fodjo JN, De Coninck L, Matthijnssens J, Mertens I, Polman K, Colebunders R. Onchocerciasis-associated epilepsy: an explorative case-control study with viral metagenomic analyses on Onchocerca volvulus. F1000Res. 2023 Dec 11;12:1262. doi: 10.12688/f1000research.138774.2. eCollection 2023.
PMID: 38439783DERIVED
Biospecimen
skin snips O.volvulus worms
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Colebunders, MD
Universiteit Antwerpen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 7 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Emeritus professor, head NSETHIO research group, Global Health institute
Study Record Dates
First Submitted
May 8, 2023
First Posted
May 22, 2023
Study Start
June 1, 2023
Primary Completion
July 1, 2024
Study Completion
December 31, 2024
Last Updated
May 22, 2023
Record last verified: 2023-05