Clinical trial NCT05698537: Risk Factors and Etiologies of Epilepsy in Urban and Rural Rwanda
Official title: Risk Factors and Etiologies of Epilepsy in Urban and Rural Rwanda
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: Epilepsy
Epilepsy / etiology
Epilepsy / epidemiology
Seizures
Africa South of the Sahara
Risk Factors
Case-Control Studies
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: King Faisal Specialist Hospital & Research Center
First posted: 2023-01-26
Enrollment: 1745
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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%). 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Association between epilepsy and exposure of possible risk factors for epilepsy
timeFrame: Baseline
measure: Etiologies of epilepsy
timeFrame: Baseline
Secondary outcomes:
measure: Male and female epilepsy risk factors and etiologies
timeFrame: Baseline
measure: Prevalence of epilepsy
timeFrame: Baseline
measure: Diagnosis gap
timeFrame: Baseline
Other outcomes:
Locations:
city: Kigali
country: Rwanda
facility: King Faisal Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Paul Boon, MD-PhD
role: STUDY_CHAIR
affiliation: University Hospital, Ghent
name: Dirk Teuwen, MD
role: STUDY_DIRECTOR
affiliation: University Hospital, Ghent
name: Ieme Garrez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sebera 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.