Onchocercal Subcutaneous NoduleNCT05868551
Onchocerciasis-Associated Epilepsy, an Explorative Case-control Study
An observational study of Onchocercal Subcutaneous Nodule and Epilepsy, run by Universiteit Antwerpen at 1 site in South Sudan.
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. Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Onchocercal Subcutaneous Nodule, Epilepsy, Virus
- What is being tested?
- nodulectomy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteSouth Sudan
- Study dates
- 1 Jun 2023to 31 Dec 2024
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 35 years
- All sexes
- Child, Adult
Study population: Cases: persons with onchocerciasis nodules and OAE Controls: persons with onchocerciasis nodules without epilepsy
Who may be able to join
- Onchocerciasis nodules
- Age 12-35 years old
- informed consent signed
- Living in Maridi County, Western Equatorial State, South Sudan
Who cannot join
- below the age of 12
Trial locations and contacts
1 site in 1 country.
South Sudan1 site
Amref Health Africa
Juba, Central, 140
About this study
Official title: 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.
Read the 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.
- Conditions
- Onchocercal Subcutaneous Nodule, Epilepsy, Virus
- Being tested
- nodulectomy
- Keywords
- Onchocerciasis, Epilepsy, metagenomics, South Sudan, Pathogenesis
- Medical subject headings
- Epilepsy, Virus Diseases, Onchocerciasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nodulectomyProcedure or surgery
incision in an onchocerciasis nodule to extract adult worms
| Study group | Role | What they receive |
|---|---|---|
| Persons with onchocerciasis nodules with OAE and without epilepsy | nodulectomy to extract adult worms Receives: Procedure: nodulectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Onchocercal Subcutaneous NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- Amref Health Africa
- Responsible party
- Principal investigator, Robert Colebunders, Universiteit Antwerpen
- Investigators
- Robert Colebunders, MD, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868551
- Sponsor's protocol ID
- AID 011898
- Status last verified
- May 2023
- First submitted
- 8 May 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 38439783
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onchocerciasis-Associated Epilepsy, an Explorative Case-control Study With Viral Metagenomic Analysis of Onchocerca Volvulus.
- ClinicalTrials.gov ID
- NCT05868551
- Acronym / sponsor ID
- AID 011898
- Conditions
- Onchocercal Subcutaneous Nodule, Epilepsy, Virus
- Keywords
- Onchocerciasis, Epilepsy, metagenomics, South Sudan, Pathogenesis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Amref Health Africa
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons with onchocerciasis nodules with OAE and without epilepsy | – | Procedure: nodulectomynodulectomy to extract adult worms |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Cases: persons with onchocerciasis nodules and OAE Controls: persons with onchocerciasis nodules without epilepsy
Key inclusion criteria (4 listed)
- Onchocerciasis nodules
- Age 12-35 years old
- informed consent signed
- Living in Maridi County, Western Equatorial State, South Sudan
Key exclusion criteria (1 listed)
- below the age of 12
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nodulectomyincision in an onchocerciasis nodule to extract adult worms | Procedure or surgery | Persons with onchocerciasis nodules with OAE and without epilepsy |
Primary outcome
The O. volvulus virome of persons with onchocerciasis-associated epilepsy (OAE) and of persons with onchocerciasis but without epilepsy
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Derived from this study: PubMed 38439783Hadermann 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Colebunders, MD principal investigator
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Onchocercal Subcutaneous Nodule and Epilepsy, run by Universiteit Antwerpen at 1 site in South Sudan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Sudan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Colebunders, MD (+32486920149, robert.colebunders@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The O. volvulus virome of persons with onchocerciasis-associated epilepsy (OAE) and of persons with onchocerciasis but without epilepsy (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05868551, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.