Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2025-12-17 @ 5:15 AM
Study NCT ID:
NCT05698537
Status:
None
Last Update Posted:
2024-06-20 00:00:00
First Post:
2023-01-04 00:00:00
Brief Title:
Risk Factors and Etiologies of Epilepsy in Urban and Rural Rwanda
Sponsor:
University Hospital Ghent
Organization:
University Hospital, Ghent
Study Overview
Official Title:
Risk Factors and Etiologies of Epilepsy in Urban and Rural Rwanda
Status:
None
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REpiCa
Brief Summary:
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.
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.
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 11 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 12 PwE will be matched with control persons defined as persons who screened negative during the Task 11 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 21 and the identification of underlying etiology in PwE according to the International League Against Epilepsy ILAE etiology guidelines Task 22
Task 21 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 22 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
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 21 and the identification of underlying etiology in PwE according to the International League Against Epilepsy ILAE etiology guidelines Task 22
Task 21 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 22 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None