Treatment of Patients With Active Neurocysticercosis in Eastern Africa

Study Overview
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Brief Summary
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This multi-centre prospective cohort study of symptomatic patients with active neurocysticercosis (NCC) aims to identify factors related to treatment success of anthelmintic therapy. Neurological symptom/sign and cyst resolution, quality of life, accuracy and performance of serological T. solium diagnostics and NCC-specific immunological parameter will be followed up at multiple time points in the study. The final assessment will be done six months after the end of anthelmintic treatment. This study aims to guide treatment of NCC in sub-Saharan Africa by identifying factors that are associated with treatment outcomes. The factors that cause some people to fail complete resolution of all cysts and/or symptoms/signs are unknown.

Official Title
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Characteristics of Patients With Symptomatic Active Neurocysticercosis and Effect of Treatment on Symptoms, Lesions and Quality of Life in Resource-poor Rural Areas of Eastern Africa - TOPANA, a Multi-centre Prospective Cohort Study.

Conditions
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Neurocysticercosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients will be included who Meet the definitions of active NCC Have epilepsy, epileptic seizures or chronic/severe progressive headaches Are physically and mentally fit enough for treatment Are willing to be hospitalized and to receive the standard treatment for NCC Are willing to participate a follow-up for six months Are willing and able to consent to this study, with consent recorded on a signed consent form Exclusion Criteria: Potential participants who will not meet the above inclusion criteria will be excluded. Women who are pregnant will not be included, but re-evaluated for inclusion into the study after they have given birth. Potential participants who are currently taking or have taken albendazole, praziquantel, or a corticosteroid within the past 12 months will be excluded. People with uncontrolled hypertension and/or diabetes will be excluded from the study but will be re-evaluated for inclusion once their hypertension and/or diabetes have been treated. People with chronic consuming illness such as cancer and those with mental handicap severe enough to not allow them to follow the study instructions or reliably take their medication will be excluded. Children aged <10 years.

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of lesions | The number of active cysts identified by CT scan after treatment | Change in number of active cysts from before treatment to six months after treatment termination | 
| Symptom/sign frequency | The percentage of participants who exhibit a neurological symptom/sign of NCC: chronic/severe progressive headache or epileptic seizures. | Change of symptom/sign frequency from before treatment to six months after treatment termination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related Quality of Life (all patients): WHOQOL-Bref questionnaire | The change in participants' self-reported quality of life from before to after treatment, as measured by the WHOQOL-Bref questionnaire (in all participants) [World Health Organization Quality of Life questionnaire; consisting of 26 items]. Quality of life is assessed by four domains - physical health, psychological, social relationships and environment. In each domain a score of 0 to 100 can be achieved. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). Domains are not summarised to an overall score. | Change in quality of life from before treatment to six months after treatment termination | 
| Health-related Quality of Life (epileptic patients) | The change in participants' self-reported quality of life from before to after treatment, as measured by the QOLIE-31 questionnaire [Quality of life in epilepsy - 31 items]. The score consists of 7 domains which all are range from 0 to 100%. Those domains are: seizure worry, overall quality of life, emotional well-being, energy/fatigue, cognitive, medication effects, social function. The seven domains are then summarized to an overall score by applying weights to each category. The overall score ranges from 0 to 100% with 100% being best possible quality of life. | Change in quality of life from before treatment to six months after treatment termination | 
| Change in presence of T.solium-specific antigen | Change in presence of T.solium-specific antigen in the blood of patients with active neurocysticercosis | Change in presence of T.solium-specific antigen from before treatment to six months after treatment termination |