Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04706819
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-01-13
First Post:
2021-01-03
Brief Title:
Parenchymal and Extraparenchymal Neurocysticercosis-A Registry Based Study
Sponsor:
All India Institute of Medical Sciences New Delhi
Organization:
All India Institute of Medical Sciences New Delhi
Study Overview
Official Title:
Clinical Laboratory and Imaging Features Treatment Trends and Long Term Outcomes in Patients With Parenchymal and Extraparenchymal Neurocysticercosis-A Registry Based Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
NeurocysticercosisNCC 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 recommended2 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
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 recommended2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None