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临床试验/NCT04706819
NCT04706819尚未招募不适用

Clinical, Laboratory and Imaging Features, Treatment Trends and Long Term Outcomes in Patients With Parenchymal and Extraparenchymal Neurocysticercosis-A Registry Based Study

All India Institute of Medical Sciences, New Delhi0 个研究点目标入组 1,000 人开始时间: 2021年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,000
主要终点
Laboratory features

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Not willing to provide consent

结局指标

主要结局

Laboratory features

时间窗: 6 months

To study the hematologic and CSF parameters in patients with parenchymal and extraparenchymal neurocysticercosis

Extra-parenchymal neurocysticercosis

时间窗: 6 months

To find the proportion of patients having extra-parenchymal neurocysticercosis

Clinical features in patients with parenchymal and extraparenchymal neurocysticercosis

时间窗: 6 months

To study the clinical features in patients with parenchymal and extraparenchymal neurocysticercosis

Imaging features

时间窗: 6 months

To study the imaging features in patients with parenchymal and extraparenchymal neurocysticercosis

Treatment trends in patients with parenchymal and extraparenchymal neurocysticercosis

时间窗: 5 years

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

Outcomes in patients with parenchymal and extraparenchymal neurocysticercosis

时间窗: 5 years

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

Outcomes in patients with parenchymal and extraparenchymal neurocysticercosis - 6 months

时间窗: 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

次要结局

  • Factors determining outcomes in patients with extra-parenchymal neurocysticercosis(5 years)
  • Factors determining outcomes in patients with parenchymal neurocysticercosis(5 years)

研究者

发起方
All India Institute of Medical Sciences, New Delhi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Arunmozhimaran Elavarasi

Assistant Professor, Department of Neurology

All India Institute of Medical Sciences, New Delhi

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