Risk Factors and Etiologies of Epilepsy in Urban and Rural Rwanda

NCT05698537 | Completed

• 1 other identifier: ONZ-2022-0403
• Study Type: observational
• Target: 1,745
• Locations: 1 country
• Sites: 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.

Conditions

Epilepsy

Keywords

Epilepsy; Epilepsy / etiology; Epilepsy / epidemiology; Seizures; Africa South of the Sahara; Risk Factors; Case-Control Studies

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline

Secondary Outcomes (3)

• Male and female epilepsy risk factors and etiologies

  Baseline

• Prevalence of epilepsy

  Baseline

• Diagnosis gap

  Baseline

Study Arms (2)

People living with epilepsy (PwE)

Study participants with epilepsy

Diagnostic Test: EEG; Diagnostic Test: Neuroimaging; Diagnostic Test: Blood sample; Other: Risk factor questionnaire

Control subjects

Study participants without epilepsy

Diagnostic Test: Blood sample; Other: Risk factor questionnaire

Interventions

EEG DIAGNOSTIC_TEST

EEG registration performed in PwE to confirm epilepsy diagnosis

People living with epilepsy (PwE)

Neuroimaging DIAGNOSTIC_TEST

Neuroimaging performed in PwE to diagnose epilepsy etiology

Also known as: CT/MRI

People living with epilepsy (PwE)

Blood sample DIAGNOSTIC_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.

Control subjects; People living with epilepsy (PwE)

Risk factor questionnaire OTHER

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.

Control subjects; People living with epilepsy (PwE)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• King Faisal Specialist Hospital & Research Center: collaborator

Study Sites (1)

King Faisal Hospital

Kigali, Rwanda

Location

Related Publications (2)

• 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.

  PMID: 34661989 BACKGROUND

• 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.

  PMID: 25936276 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

Electroencephalography; Neuroimaging; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Diagnostic Imaging; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative

Study Officials

• Paul Boon, MD-PhD

  University Hospital, Ghent

  STUDY CHAIR

• Dirk Teuwen, MD

  University Hospital, Ghent

  STUDY DIRECTOR

• Ieme Garrez, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 26, 2023
• Study Start: May 31, 2022
• Primary Completion: May 24, 2024
• Study Completion: May 24, 2024
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available upon publication of the research results.
• Access Criteria: Open Access repository

Locations

RW (1)