EpilepsyREpiCaNCT05698537
Risk Factors and Etiologies of Epilepsy in Urban and Rural Rwanda
An observational study of Epilepsy, run by University Hospital, Ghent at 1 site in Rwanda.
Trial summary
Epilepsy is one of the most common chronic brain disorders. Up to 85% of persons living with epilepsy (PwE) live in the developing world. In sub-Saharan Africa (SSA), Rwanda has one of the highest prevalence rates (±5%). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- EEG, Neuroimaging and Blood sample
- How many people
- 1,745 participants
- Where
- 1 siteRwanda
- Study dates
- 31 May 2022to 24 May 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will be recruited using two surveys. The first survey (Task 1.1.) will be conducted in the general population of the 10 selected villages. Persons of the households with permanent residence will be interviewed by enumerators during door-to-door visits using the Limoges epilepsy screening questionnaire. If a person screens positive, they will be assessed by a team of Rwandan and Belgian neurologists to confirm epilepsy diagnosis. Subsequently, PwE will be matched with control persons through a second survey (Task 1.2.). Persons with a negative screening during the first survey who match for age and gender will be contacted for a clinical assessment by Rwandan and Belgian neurologists to confirm absence of epilepsy. Final matching will have a ratio 1:1.
Who may be able to join
- Inhabitants of the selected villages who screen positive on the Limoges epilepsy screening questionnaire during the D2D visits and have a confirmed epilepsy diagnosis assessed by a team of Rwandan and Belgian neurologists, are included as PwE. Epilepsy will be defined as unprovoked recurrent seizures occurring more than 24h apart, including active and lifetime epilepsy.
- Persons with a negative screening during the D2D visits who match with a PwE for age and gender and have an absence of epilepsy confirmed during a clinical assessment by a team of Rwandan and Belgian neurologists, are included as control persons.
Who cannot join
- Inhabitants of the selected villages who are unwilling to complete a verbal witnessed informed consent during D2D visits. For patients ≤18 years of age, verbal consent will be obtained from their parents/caregivers.
- PwE and selected control persons who are unwilling to sign a written informed consent upon referral for neurological assessment.
- PwE and control persons not meeting the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Epilepsy is one of the most common chronic brain disorders. Up to 85% of persons living with epilepsy (PwE) live in the developing world. In sub-Saharan Africa (SSA), Rwanda has one of the highest prevalence rates (±5%). Higher prevalence in low-and middle-income countries (LMICs) can partly be attributed to differences in risk factors for epilepsy of which a great number are preventable. Expanding knowledge on risk factors and etiologies of epilepsy in Rwanda can lower the portion of preventable epilepsies and decrease the high number of Rwandan PwE. This project will focus on the investigation of risk factors and etiologies of epilepsy in urban and rural Rwanda using a nationwide approach.
Read the detailed description
Risk factors and etiologies of epilepsy in the Rwandan population will be determined using two phases. The initial phase (Task 1) includes the recruitment of the study population using two separate surveys. The first survey (Task 1.1.) will be conducted in the general population by a door-to-door (D2D) approach. During D2D visits in 10 selected urban and rural villages throughout the country, one rural and one urban per province, persons of the households with permanent residence will be interviewed by enumerators to screen for epilepsy. In case of a positive screening, they will be assessed by a team of Rwandan and Belgian neurologists to confirm the epilepsy diagnosis. During a second survey (Task 1.2.), PwE will be matched with control persons defined as persons who screened negative during the Task 1.1 survey.
The second phase of our study (Task 2) consists of the assessment of potential risk factors associated with epilepsy using the matched case-control group (Task 2.1.), and the identification of underlying etiology in PwE according to the International League Against Epilepsy (ILAE) etiology guidelines (Task 2.2.).
Task 2.1. Both cases and controls will complete a structured questionnaire on a wide range of potential risk factors present before the onset of the epilepsy, administered by research assistants. In addition, blood samples from both PwE and controls will be collected as to measure the exposure to parasitic infections and HIV, and the presence of sickle cell disease, among others. Exposure will be measured by detection of IgG antibodies to parasitic antigens including Taenia solium, Toxoplasma gondii and Plasmodium falciparum as well as HIV in plasma samples of the participants.
Task 2.2. Further, in order to classify PwE according to the ILAE etiology guidelines, we will use the detailed medical and epilepsy history including in-depth narrative of seizure description and frequency, clinical examination and narrative of epilepsy treatment assessed by the team of neurologists subsequent to the confirmation of the epilepsy diagnosis. In addition, all PwE will undergo EEG recording using a mobile device. Furthermore, PwE will undergo CT- or MRI-imaging unless previous imaging studies have been performed and are accessible for re-evaluation.
- Conditions
- Epilepsy
- Being tested
- EEG, Neuroimaging, Blood sample, Risk factor questionnaire
- Keywords
- Epilepsy, Epilepsy / etiology, Epilepsy / epidemiology, Seizures, Africa South of the Sahara, Risk Factors, Case-Control Studies
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGDiagnostic test
EEG registration performed in PwE to confirm epilepsy diagnosis
NeuroimagingDiagnostic test
Also called CT/MRI
Neuroimaging performed in PwE to diagnose epilepsy etiology
Blood sampleDiagnostic test
Blood samples from both PwE and controls will be collected to measure full blood count, IgM and IgG antibodies to parasitic antigens including Taenia solium, Toxoplasma gondii and Plasmodium falciparum, to perform ELISA for HIV1 and HIV2, to measure HIV viral load and to conduct an emmel test.
Risk factor questionnaireOther
Both PwE and control subjects will complete a structured questionnaire on a wide range of potential risk factors present before the onset of the epilepsy.
| Study group | Role | What they receive |
|---|---|---|
| People living with epilepsy (PwE) | Study participants with epilepsy Receives: Diagnostic Test: EEG; Diagnostic Test: Neuroimaging; Diagnostic Test: Blood sample; Other: Risk factor questionnaire | |
| Control subjects | Study participants without epilepsy Receives: Diagnostic Test: Blood sample; Other: Risk factor questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between epilepsy and exposure of possible risk factors for epilepsy
The following risk factors will be assessed in both PwE and control subjects: family history of seizures, history of febrile seizures, history of head trauma, history of CNS infections and tuberculosis, history of perinatal events, cassava consumption and malnutrition, immunization status against common communicable diseases, history of cerebrovascular disease including hypertension, hypercholesterolemia and diabetes mellitus as primary risk factors and consumption of alcohol, drugs and tobacco; using a risk factor questionnaire. Additional risk factors including exposure to parasitic infections e.g., toxoplasmosis, malaria, neurocysticercosis and HIV, and the presence of sickle cell disease, among others, will be measured by analysis of blood samples. Primary risk factors associated with the mentioned parasitic infections and HIV are included in the questionnaire.
Measured: Baseline
Etiologies of epilepsy
Etiologies of epilepsy in PwE will be classified according to the 2017 International League Against Epilepsy (ILAE) criteria using detailed medical and epilepsy history, clinical examination and paraclinical investigations including EEG recording and neuroimaging in PwE only.
Measured: Baseline
Secondary outcomes (3)
Male and female epilepsy risk factors and etiologies
A sub-analysis comparing male and female epilepsy risk factors and etiologies will be conducted.
Measured: Baseline
Prevalence of epilepsy
Establishment of prevalence of epilepsy in selected villages
Measured: Baseline
Diagnosis gap
Previous diagnosis of epilepsy if applicable, including who initially made the diagnosis and when, will be self-reported during epilepsy screening in the selected villages defining newly and previously diagnosed patients (diagnosis gap).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start31 May 2022
- Primary completion24 May 2024
- Study completion24 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- 1,745 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- King Faisal Specialist Hospital & Research Center
- Responsible party
- Sponsor
- Investigators
- Paul Boon, MD-PhD, Study chair, University Hospital, GhentDirk Teuwen, MD, Study director, University Hospital, GhentIeme Garrez, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698537
- Sponsor's protocol ID
- ONZ-2022-0403
- Acronym
- REpiCa
- Status last verified
- Jun 2024
- First submitted
- 4 Jan 2023
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized, analytical datasets and statistical outputs as well as final study documents including figures and tables will be offered for deposit to 4TU.ResearchData, which is a certified data repository accepting research data in the field of medicine and health care and preserving them for a minimum of 15 years.
Publications
Dedeken P, Sebera F, Mutungirehe S, Garrez I, Umwiringirwa J, Van Steenkiste F, Boon PAJM, Teuwen DE. High prevalence of epilepsy in Northern Rwanda: Exploring gender differences. Brain Behav. 2021 Nov;11(11):e2377. doi: 10.1002/brb3.2377. Epub 2021 Oct 17.
PubMed 34661989Sebera F, Munyandamutsa N, Teuwen DE, Ndiaye IP, Diop AG, Tofighy A, Boon P, Dedeken P. Addressing the treatment gap and societal impact of epilepsy in Rwanda--Results of a survey conducted in 2005 and subsequent actions. Epilepsy Behav. 2015 May;46:126-32. doi: 10.1016/j.yebeh.2015.03.028. Epub 2015 Apr 30.
PubMed 25936276
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Etiologies of Epilepsy in Urban and Rural Rwanda
- ClinicalTrials.gov ID
- NCT05698537
- Acronym / sponsor ID
- REpiCa / ONZ-2022-0403
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Epilepsy / etiology, Epilepsy / epidemiology, Seizures, Africa South of the Sahara, Risk Factors, Case-Control Studies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,745 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- King Faisal Specialist Hospital & Research Center
- Study start
- 31 May 2022 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 26 Jan 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.
Epilepsy is one of the most common chronic brain disorders. Up to 85% of persons living with epilepsy (PwE) live in the developing world. In sub-Saharan Africa (SSA), Rwanda has one of the highest prevalence rates (±5%). Higher prevalence in low-and middle-income countries (LMICs) can partly be attributed to differences in risk factors for epilepsy of which a great number are preventable. Expanding knowledge on risk factors and etiologies of epilepsy in Rwanda can lower the portion of preventable epilepsies and decrease the high number of Rwandan PwE. This project will focus on the investigation of risk factors and etiologies of epilepsy in urban and rural Rwanda using a nationwide approach.
Detailed description
Risk factors and etiologies of epilepsy in the Rwandan population will be determined using two phases. The initial phase (Task 1) includes the recruitment of the study population using two separate surveys. The first survey (Task 1.1.) will be conducted in the general population by a door-to-door (D2D) approach. During D2D visits in 10 selected urban and rural villages throughout the country, one rural and one urban per province, persons of the households with permanent residence will be interviewed by enumerators to screen for epilepsy. In case of a positive screening, they will be assessed by a team of Rwandan and Belgian neurologists to confirm the epilepsy diagnosis. During a second survey (Task 1.2.), PwE will be matched with control persons defined as persons who screened negative during the Task 1.1 survey.
The second phase of our study (Task 2) consists of the assessment of potential risk factors associated with epilepsy using the matched case-control group (Task 2.1.), and the identification of underlying etiology in PwE according to the International League Against Epilepsy (ILAE) etiology guidelines (Task 2.2.).
Task 2.1. Both cases and controls will complete a structured questionnaire on a wide range of potential risk factors present before the onset of the epilepsy, administered by research assistants. In addition, blood samples from both PwE and controls will be collected as to measure the exposure to parasitic infections and HIV, and the presence of sickle cell disease, among others. Exposure will be measured by detection of IgG antibodies to parasitic antigens including Taenia solium, Toxoplasma gondii and Plasmodium falciparum as well as HIV in plasma samples of the participants.
Task 2.2. Further, in order to classify PwE according to the ILAE etiology guidelines, we will use the detailed medical and epilepsy history including in-depth narrative of seizure description and frequency, clinical examination and narrative of epilepsy treatment assessed by the team of neurologists subsequent to the confirmation of the epilepsy diagnosis. In addition, all PwE will undergo EEG recording using a mobile device. Furthermore, PwE will undergo CT- or MRI-imaging unless previous imaging studies have been performed and are accessible for re-evaluation.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People living with epilepsy (PwE) | – | Diagnostic Test: EEG, Diagnostic Test: Neuroimaging, Diagnostic Test: Blood sample, Other: Risk factor questionnaireStudy participants with epilepsy |
| Control subjects | – | Diagnostic Test: Blood sample, Other: Risk factor questionnaireStudy participants without epilepsy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will be recruited using two surveys. The first survey (Task 1.1.) will be conducted in the general population of the 10 selected villages. Persons of the households with permanent residence will be interviewed by enumerators during door-to-door visits using the Limoges epilepsy screening questionnaire. If a person screens positive, they will be assessed by a team of Rwandan and Belgian neurologists to confirm epilepsy diagnosis. Subsequently, PwE will be matched with control persons through a second survey (Task 1.2.). Persons with a negative screening during the first survey who match for age and gender will be contacted for a clinical assessment by Rwandan and Belgian neurologists to confirm absence of epilepsy. Final matching will have a ratio 1:1.
Key inclusion criteria (2 listed)
- Inhabitants of the selected villages who screen positive on the Limoges epilepsy screening questionnaire during the D2D visits and have a confirmed epilepsy diagnosis assessed by a team of Rwandan and Belgian neurologists, are included as PwE. Epilepsy will be defined as unprovoked recurrent seizures occurring more than 24h apart, including active and lifetime epilepsy.
- Persons with a negative screening during the D2D visits who match with a PwE for age and gender and have an absence of epilepsy confirmed during a clinical assessment by a team of Rwandan and Belgian neurologists, are included as control persons.
Key exclusion criteria (3 listed)
- Inhabitants of the selected villages who are unwilling to complete a verbal witnessed informed consent during D2D visits. For patients ≤18 years of age, verbal consent will be obtained from their parents/caregivers.
- PwE and selected control persons who are unwilling to sign a written informed consent upon referral for neurological assessment.
- PwE and control persons not meeting the inclusion criteria.
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 |
|---|---|---|
| EEGEEG registration performed in PwE to confirm epilepsy diagnosis | Diagnostic test | People living with epilepsy (PwE) |
| NeuroimagingAlso: CT/MRINeuroimaging performed in PwE to diagnose epilepsy etiology | Diagnostic test | People living with epilepsy (PwE) |
| Blood sampleBlood samples from both PwE and controls will be collected to measure full blood count, IgM and IgG antibodies to parasitic antigens including Taenia solium, Toxoplasma gondii and Plasmodium falciparum, to perform ELISA for HIV1 and HIV2, to measure HIV viral load and to conduct an emmel test. | Diagnostic test | Control subjects, People living with epilepsy (PwE) |
| Risk factor questionnaireBoth PwE and control subjects will complete a structured questionnaire on a wide range of potential risk factors present before the onset of the epilepsy. | Other | Control subjects, People living with epilepsy (PwE) |
Primary outcome
Association between epilepsy and exposure of possible risk factors for epilepsy
Time frame: Baseline
The following risk factors will be assessed in both PwE and control subjects: family history of seizures, history of febrile seizures, history of head trauma, history of CNS infections and tuberculosis, history of perinatal events, cassava consumption and malnutrition, immunization status against common communicable diseases, history of cerebrovascular disease including hypertension, hypercholesterolemia and diabetes mellitus as primary risk factors and consumption of alcohol, drugs and tobacco; using a risk factor questionnaire. Additional risk factors including exposure to parasitic infections e.g., toxoplasmosis, malaria, neurocysticercosis and HIV, and the presence of sickle cell disease, among others, will be measured by analysis of blood samples. Primary risk factors associated with the mentioned parasitic infections and HIV are included in the questionnaire.
Etiologies of epilepsy
Time frame: Baseline
Etiologies of epilepsy in PwE will be classified according to the 2017 International League Against Epilepsy (ILAE) criteria using detailed medical and epilepsy history, clinical examination and paraclinical investigations including EEG recording and neuroimaging in PwE only.
3 secondary outcomes
Male and female epilepsy risk factors and etiologies
Time frame: Baseline
Prevalence of epilepsy
Time frame: Baseline
Diagnosis gap
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Background: PubMed 34661989Dedeken P, Sebera F, Mutungirehe S, Garrez I, Umwiringirwa J, Van Steenkiste F, Boon PAJM, Teuwen DE. High prevalence of epilepsy in Northern Rwanda: Exploring gender differences. Brain Behav. 2021 Nov;11(11):e2377. doi: 10.1002/brb3.2377. Epub 2021 Oct 17.
- Background: PubMed 25936276Sebera F, Munyandamutsa N, Teuwen DE, Ndiaye IP, Diop AG, Tofighy A, Boon P, Dedeken P. Addressing the treatment gap and societal impact of epilepsy in Rwanda--Results of a survey conducted in 2005 and subsequent actions. Epilepsy Behav. 2015 May;46:126-32. doi: 10.1016/j.yebeh.2015.03.028. Epub 2015 Apr 30.
- Individual participant dataSharing planned: Yes. Anonymized, analytical datasets and statistical outputs as well as final study documents including figures and tables will be offered for deposit to 4TU.ResearchData, which is a certified data repository accepting research data in the field of medicine and health care and preserving them for a minimum of 15 years.
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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.
Paul Boon, MD-PhD study chair
University Hospital, Ghent
Dirk Teuwen, MD study director
University Hospital, Ghent
Ieme Garrez, MD principal investigator
University Hospital, Ghent
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 Epilepsy, run by University Hospital, Ghent at 1 site in Rwanda.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 20 Jun 2024. 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 Rwanda. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between epilepsy and exposure of possible risk factors for epilepsy (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT05698537, which also lists 2 linked publications.
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 20 Jun 2024.