Epilepsy Clinical Trial
— NSECOfficial title:
Clinical Features and Potential Etiology of Epilepsy and Nodding Syndrome in the Mahenge Area, Ulanga District
NCT number | NCT03653975 |
Other study ID # | HD-DZIF-MUHAS |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 2014 |
Est. completion date | May 2019 |
Background: Childhood epilepsy disorders are particular frequent in the area around Mahenge,
southern Tanzania and recent studies have described a novel type of epilepsy with repetitive
head nodding episodes and often progressive cognitive dysfunction. Despite the disease
affecting thousands in Tanzania, Uganda and South Sudan, etiology and pathogenesis of the
disorder termed Nodding Syndrome (NS) is still obscure as the phenotype remains imprecisely
described. Epidemiological associations with Onchocerca volvulus and Mansonella spp. were
noted at different African sites and remain robust even though no evidence for the presence
of O. volvulus in CSF or any previous contact with the CSF was found.
Hypothesis: With regard to the complex host immune reaction to O. volvulus, the investigators
hypothesize that the immune response against filariae might contribute to NS and epilepsy.
The investigators further assume that specific genetic traits might play a role in the
pathogenesis of NS.
Aims In the present study the investigators aim to examine if and how O. volvulus and/or
Mansonella spp. contribute to the pathology of NS/epilepsy and therefore intend to analyze
the filarial infection and the host immune response in affected children. To identify
inherited traits predisposing for epilepsy, NS or specific immune responses, a genetic workup
that includes whole-exome sequencing (WES) is performed. The clinical and EEG characteristics
are further defined. Cognitive impairment of people with epilepsy and NS is assessed using
the Wechsler Nonverbal Scale of Ability (WNV).
Study design: A cross-sectional observational (groups I-III) and a case-control (groups I-V)
study recruiting in total 250 patients and controls (I: people with NS, n=50; II: people with
epilepsy (PWE) and onchocerciasis, n=50; III: PWE without onchocerciasis, n=50; IV: controls
with onchocerciasis but otherwise healthy, n= 50; healthy controls without evidence for
onchocerciasis, n= 50) is performed to describe the clinical characteristics in children with
NS/epilepsy and to evaluate differences in infection and immune response between groups,
respectively. The WNV should be validated in 500 healthy controls to obtain reference data in
rural Africa.
Summary: In summary, the study aims to elucidate clinical characteristics and the
pathogenesis of NS/epilepsy in children of southern Tanzania and role of parasitic infection
as a cause for NS/epilepsy.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | May 2019 |
Est. primary completion date | May 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 99 Years |
Eligibility |
I) Patients with Nodding syndrome confirmed or suspected Case of Nodding syndrome
(according to the WHO epidemiologic surveillance case definition: reported head nodding in
a previously healthy person with at least 2 major and 1 minor criteria Major criteria Age 3
to 18 y at onset of head nodding Nodding frequency 5 to 20 times per min Minor criteria
Other neurologic abnormalities (cognitive decrease, school dropout due to cognitive or
behavioral problems, other seizures or neurologic abnormalities) Clustering in space or
time with similar cases Triggering by eating or cold weather Delayed sexual or physical
development Psychiatric manifestations As agreed upon at the first International Conference on Nodding Syndrome, Kampala, Uganda, July 2012 (16). EEG, II) People with epilepsy (PWE) and onchocerciasis confirmed or clinically suspected generalized and idiopathic epilepsy confirmed active infection with O. volvulus (microscopy, PCR and serology) III) People with epilepsy (PWE) without onchocerciasis confirmed or clinically suspected generalized and idiopathic epilepsy excluded active or past infection with O. volvulus (microscopy, PCR and serology) IV) Controls with onchocerciasis, otherwise healthy no evidence for epilepsy or other neurological diseases confirmed active infection with O. volvulus (microscopy, PCR and serology) V) Controls without onchocerciasis, otherwise healthy no evidence for epilepsy or other neurological diseases excluded active or past infection with O. volvulus (microscopy, PCR and serology) VI) Healthy controls for cognitive assessment, matched to Groups I to V inclusion criteria: The study groups with their respective inclusion criteria are defined above. Patients of group I-III will be first recruited into the cross-sectional study and subsequently into the case-control study. Groups II to VI will be matched to Group I for age, gender, social status and stay within the Mahenge area. exlusion criteria: Patients with evidence for co-infections with HIV, Tb, Malaria or other parasites, cardiovascular or renal comorbidities, a history of birth or traumatic brain injuries, psychiatric comorbidities, insecure comprehension of the information given, lacking or withdrawn consent will be excluded. |
Country | Name | City | State |
---|---|---|---|
Tanzania | Mahenge Epilepsy Clinic | Mahenge |
Lead Sponsor | Collaborator |
---|---|
Heidelberg University |
Tanzania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Describing clinical features in children with Nodding Syndrome and other forms of epilepsy e.g. characteristics of the seizures, EEG abnormalities and reporting co-morbidities and impairments. | Obtaining clinical features and medical history. Comparing medical history, Seizure types and -frequency and other clinical Features between the groups. | 2014-2018 | |
Primary | Describing EEG features in children with Nodding Syndrome and other forms | Performing EEG recordings and comparing EEG abnormalities (numbers, types and site of epileptiform discharges (ED), background alterations) between the groups. | 2014-2018 | |
Secondary | Measuring the rate of filarial infections in patients with NS, epilepsy and controls. | Performing skin snip microscopy and PCR analysis to detect O. volvulus and Mansonella spp. in patients with NS, epilepsy and controls. | 2014-2018 | |
Secondary | Characterization of O. volvulus in patients with Nodding Syndrome and epilepsy. | 2014-2018 | ||
Secondary | Characterization of the host immune response to O. volvulus. | 2014-2018 | ||
Secondary | Analyzing for genetic traits associated with epilepsy, NS, enhanced Ivermectin toxicity or specific immune responses. | Performing a genetic workup for known monogenetic forms of epilepsy, single nucleotide polymorphisms (SNP) associated with enhanced Ivermectin toxicity and adverse immune reactions. Performing a Whole-exome sequencing (WES) with biomedical analysis. | 2014-2018 | |
Secondary | Measuring the cognitive impairment in patients with NS and epilepsy. | Using the Wechsler Nonverbal Scale of Ability (WNV) and comparing the results to matched healthy controls. | 2014-2018 |
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