Clinical trial NCT04706819: Parenchymal and Extraparenchymal Neurocysticercosis-A Registry Based Study
Official title: Clinical, Laboratory and Imaging Features, Treatment Trends and Long Term Outcomes in Patients With Parenchymal and Extraparenchymal Neurocysticercosis-A Registry Based Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neurocysticercosis
Tropical Disease
Tenia Solium Infection
Keywords: Parenchymal Neurocysticercosis
Extraparenchmal Neurocysticercosis
Intraventricular neurocysticercosis
Racemose neurocysticercosis
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study Population: Patients with MRI/CT diagnosed neurocysticercosis as per composite clinical criteria, imaging criteria as well as natural history

Brief summary: Neurocysticercosis(NCC) is the commonest parasitic infection of the central nervous system. It is the commonest cause of focal seizures in India. It can also present with headaches, movement disorders, stroke, cognitive decline and multitude of complications depending on its location. Parenchymal NCC is more common than extraparenchymal NCC. There is considerable variation in the treatment practices including administration of anti-helminthic agents and corticosteroids. Extra-parenchymal NCC is rare and can occur in the subarachnoid space or intraventricularly. Extra-parenchymal NCC is managed surgically in several instances. There is scant literature on the long term follow up of this condition. This registry will enable collection of data on the clinical, laboratory and imaging features, treatment trends and long term outcomes of both parenchymal and extra-parenchymal neurocysticercosis.

Detailed description: Neurocysticercosis (NCC) is the commonest parasitic infection of the central nervous system. It can affect the brain, meninges, eyes as well as other parts of the body. Disseminated cysticercosis involves brain and one other organ such as muscles, viscera etc. NCC is common in tropical countries and is the commonest cause of focal seizures. It is quite frequently also found incidentally in imaging done for unrelated conditions such as headaches and trauma. NCC can be parenchymal or extra-parenchymal. Parenchymal NCC is commoner than extra-parenchymal lesions. Some patients with parenchymal NCC have less than three cysts and they have seizures which are well controlled with medication. On the other hand some have multiple cysts and present with complications such as stroke, cognitive decline, aphasia, hydrocephalus, increased intra-cranial pressure etc. Cysts occurring extra-parenchymal locations such as inside the ventricular system or sub-arachnoid space are less common than parenchymal ones, but can be more symptomatic due to obstruction in the CSF flow leading to hydrocephalus, arachnoiditis and impaired CSF absorption etc.

Though NCC is very common in the Indian subcontinent, there is no consensus on optimum management strategies. There is a wide variation in the practices of prescribing anti-helminthic drugs, corticosteroids, steroid sparing agents etc. Clinical experience suggests that some patients with NCC need long term corticosteroids and on withdrawing corticosteroids, they develop peri-lesional edema and they become symptomatic. In such patients, steroid sparing agents such as methotrexate are recommended.2 However there is no data on the long term follow up of such patients especially from India. Similarly, patients with intraventricular NCC treated surgically are given varying types of anti-helminthic therapy ranging from none to combination therapy after surgical /endoscopic resection of the cysts.

It is high time, that a registry is established and patient data collected systematically, to enable analysis of clinical features as well as to study the patterns of treatment offered by individual physicians. This will also promote the development of hypothesis for planning trials in future.

Eligibility criteria: Inclusion Criteria:

* Patients attending Neurology OPD or are admitted in wards with neurocysticercosis diagnosed on the basis of composite clinical criteria, imaging criteria as well as natural history
* Atleast 14 years of age of all sexes
* Reasonable clinical certainty OR allied investigations such as CXR/CECT chest/abdomen/PET CT as per clinical indication ruling out tuberculosis or mimics of neurocysticercosis
* Other relevant investigations like CSF analysis not suggestive of alternative diagnosis such as tubercular/ cryptococcal/other fungal infections/other causes of chronic meningitis such as brucella/ nocardia/ syphilis/recurrent viral meningitis/ carcinomatous/ lymphomatous meningitis or non infective causes such as sarcoidosis/sub-arachnoid hemorrhage etc.

Exclusion Criteria:

• Not willing to provide consent

Primary outcomes:
measure: Clinical features in patients with parenchymal and extraparenchymal neurocysticercosis
timeFrame: 6 months
measure: Laboratory features
timeFrame: 6 months
measure: Imaging features
timeFrame: 6 months
measure: Treatment trends in patients with parenchymal and extraparenchymal neurocysticercosis
timeFrame: 6 months
measure: Treatment trends in patients with parenchymal and extraparenchymal neurocysticercosis
timeFrame: 1 year
measure: Treatment trends in patients with parenchymal and extraparenchymal neurocysticercosis
timeFrame: 3 years
measure: Treatment trends in patients with parenchymal and extraparenchymal neurocysticercosis
timeFrame: 5 years
measure: Outcomes in patients with parenchymal and extraparenchymal neurocysticercosis - 6 months
timeFrame: 6 months
measure: Outcomes in patients with parenchymal and extraparenchymal neurocysticercosis
timeFrame: 1 year
measure: Outcomes in patients with parenchymal and extraparenchymal neurocysticercosis
timeFrame: 3 years
measure: Outcomes in patients with parenchymal and extraparenchymal neurocysticercosis
timeFrame: 5 years
measure: Extra-parenchymal neurocysticercosis
timeFrame: 6 months
Secondary outcomes:
measure: Factors determining outcomes in patients with parenchymal neurocysticercosis
timeFrame: 1 year
measure: Factors determining outcomes in patients with parenchymal neurocysticercosis
timeFrame: 3 years
measure: Factors determining outcomes in patients with parenchymal neurocysticercosis
timeFrame: 5 years
measure: Factors determining outcomes in patients with extra-parenchymal neurocysticercosis
timeFrame: 1 year
measure: Factors determining outcomes in patients with extra-parenchymal neurocysticercosis
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: All India Institute of Medical Sciences
name: Arunmozhimaran Elavarasi, MD DM
role: PRINCIPAL_INVESTIGATOR
affiliation: All India Institute of Medical Sciences
name: Ajay Garg, MD DM
role: PRINCIPAL_INVESTIGATOR
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