Neurocysticercosis Clinical Trial
Official title:
Clinical, Laboratory and Imaging Features, Treatment Trends and Long Term Outcomes in Patients With Parenchymal and Extraparenchymal Neurocysticercosis-A Registry Based Study
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.
Status | Not yet recruiting |
Enrollment | 1000 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years and older |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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All India Institute of Medical Sciences, New Delhi |
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Nash TE, O'Connell EM, Hammoud DA, Wetzler L, Ware JM, Mahanty S. Natural History of Treated Subarachnoid Neurocysticercosis. Am J Trop Med Hyg. 2020 Jan;102(1):78-89. doi: 10.4269/ajtmh.19-0436. — View Citation
Nash TE, Pretell EJ, Lescano AG, Bustos JA, Gilman RH, Gonzalez AE, Garcia HH; Cysticercosis Working Group in Peru. Perilesional brain oedema and seizure activity in patients with calcified neurocysticercosis: a prospective cohort and nested case-control study. Lancet Neurol. 2008 Dec;7(12):1099-105. doi: 10.1016/S1474-4422(08)70243-6. Epub 2008 Nov 3. — View Citation
Nash TE, Ware JM, Mahanty S. Intraventricular Neurocysticercosis: Experience and Long-Term Outcome from a Tertiary Referral Center in the United States. Am J Trop Med Hyg. 2018 Jun;98(6):1755-1762. doi: 10.4269/ajtmh.18-0085. Epub 2018 Apr 19. — View Citation
Ooi WW, Wijemanne S, Thomas CB, Quezado M, Brown CR, Nash TE. Short report: A calcified Taenia solium granuloma associated with recurrent perilesional edema causing refractory seizures: histopathological features. Am J Trop Med Hyg. 2011 Sep;85(3):460-3. doi: 10.4269/ajtmh.2011.11-0221. — View Citation
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical features in patients with parenchymal and extraparenchymal neurocysticercosis | To study the clinical features in patients with parenchymal and extraparenchymal neurocysticercosis | 6 months | |
Primary | Laboratory features | To study the hematologic and CSF parameters in patients with parenchymal and extraparenchymal neurocysticercosis | 6 months | |
Primary | Imaging features | To study the imaging features in patients with parenchymal and extraparenchymal neurocysticercosis | 6 months | |
Primary | Treatment trends in patients with parenchymal and extraparenchymal neurocysticercosis | To study the treatment trends in terms of proportion of patients treated with anti-epileptic drugs, anti-parasitic drugs, corticosteroids, steroid sparing agents, surgical management in patients with parenchymal and extraparenchymal neurocysticercosis | 6 months | |
Primary | Treatment trends in patients with parenchymal and extraparenchymal neurocysticercosis | To study the treatment trends in terms of proportion of patients treated with anti-epileptic drugs, anti-parasitic drugs, corticosteroids, steroid sparing agents, surgical management in patients with parenchymal and extraparenchymal neurocysticercosis | 1 year | |
Primary | Treatment trends in patients with parenchymal and extraparenchymal neurocysticercosis | To study the treatment trends in terms of proportion of patients treated with anti-epileptic drugs, anti-parasitic drugs, corticosteroids, steroid sparing agents, surgical management in patients with parenchymal and extraparenchymal neurocysticercosis | 3 years | |
Primary | Treatment trends in patients with parenchymal and extraparenchymal neurocysticercosis | To study the treatment trends in terms of proportion of patients treated with anti-epileptic drugs, anti-parasitic drugs, corticosteroids, steroid sparing agents, surgical management in patients with parenchymal and extraparenchymal neurocysticercosis | 5 years | |
Primary | Outcomes in patients with parenchymal and extraparenchymal neurocysticercosis - 6 months | To study the outcomes in terms of seizure freedom, symptom resolution, new symptoms, imaging resolution and functional status in patients with parenchymal and extraparenchymal neurocysticercosis | 6 months | |
Primary | Outcomes in patients with parenchymal and extraparenchymal neurocysticercosis | To study the outcomes in terms of seizure freedom, symptom resolution, new symptoms, imaging resolution and functional status in patients with parenchymal and extraparenchymal neurocysticercosis | 1 year | |
Primary | Outcomes in patients with parenchymal and extraparenchymal neurocysticercosis | To study the outcomes in terms of seizure freedom, symptom resolution, new symptoms, imaging resolution and functional status in patients with parenchymal and extraparenchymal neurocysticercosis | 3 years | |
Primary | Outcomes in patients with parenchymal and extraparenchymal neurocysticercosis | To study the outcomes in terms of seizure freedom, symptom resolution, new symptoms, imaging resolution and functional status in patients with parenchymal and extraparenchymal neurocysticercosis | 5 years | |
Primary | Extra-parenchymal neurocysticercosis | To find the proportion of patients having extra-parenchymal neurocysticercosis | 6 months | |
Secondary | Factors determining outcomes in patients with parenchymal neurocysticercosis | To study the factors determining outcomes in terms of seizure freedom, resolution of symptoms, disappearance of lesions on imaging and functional status as assessed by modified Rankin scale in patients with parenchymal neurocysticercosis | 1 year | |
Secondary | Factors determining outcomes in patients with parenchymal neurocysticercosis | To study the factors determining outcomes in terms of seizure freedom, resolution of symptoms, disappearance of lesions on imaging and functional status as assessed by modified Rankin scale in patients with parenchymal neurocysticercosis | 3 years | |
Secondary | Factors determining outcomes in patients with parenchymal neurocysticercosis | To study the factors determining outcomes in terms of seizure freedom, resolution of symptoms, disappearance of lesions on imaging and functional status as assessed by modified Rankin scale in patients with parenchymal neurocysticercosis | 5 years | |
Secondary | Factors determining outcomes in patients with extra-parenchymal neurocysticercosis | To study the factors determining outcomes in terms of seizure freedom, resolution of symptoms, disappearance of lesions on imaging and functional status as assessed by modified Rankin scale in patients with extra-parenchymal neurocysticercosis | 1 year | |
Secondary | Factors determining outcomes in patients with extra-parenchymal neurocysticercosis | To study the factors determining outcomes in terms of seizure freedom, resolution of symptoms, disappearance of lesions on imaging and functional status as assessed by modified Rankin scale in patients with extra-parenchymal neurocysticercosis | 5 years |
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