Parenchymal and Extraparenchymal Neurocysticercosis-A Registry Based Study

January 9, 2021 updated by: Arunmozhimaran Elavarasi, All India Institute of Medical Sciences, New Delhi

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical features in patients with parenchymal and extraparenchymal neurocysticercosis
Time Frame: 6 months
To study the clinical features in patients with parenchymal and extraparenchymal neurocysticercosis
6 months
Laboratory features
Time Frame: 6 months
To study the hematologic and CSF parameters in patients with parenchymal and extraparenchymal neurocysticercosis
6 months
Imaging features
Time Frame: 6 months
To study the imaging features in patients with parenchymal and extraparenchymal neurocysticercosis
6 months
Treatment trends in patients with parenchymal and extraparenchymal neurocysticercosis
Time Frame: 6 months
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
Treatment trends in patients with parenchymal and extraparenchymal neurocysticercosis
Time Frame: 1 year
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
Treatment trends in patients with parenchymal and extraparenchymal neurocysticercosis
Time Frame: 3 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
3 years
Treatment trends in patients with parenchymal and extraparenchymal neurocysticercosis
Time Frame: 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
5 years
Outcomes in patients with parenchymal and extraparenchymal neurocysticercosis - 6 months
Time Frame: 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
Outcomes in patients with parenchymal and extraparenchymal neurocysticercosis
Time Frame: 1 year
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
Outcomes in patients with parenchymal and extraparenchymal neurocysticercosis
Time Frame: 3 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
3 years
Outcomes in patients with parenchymal and extraparenchymal neurocysticercosis
Time Frame: 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
5 years
Extra-parenchymal neurocysticercosis
Time Frame: 6 months
To find the proportion of patients having extra-parenchymal neurocysticercosis
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors determining outcomes in patients with parenchymal neurocysticercosis
Time Frame: 1 year
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
Factors determining outcomes in patients with parenchymal neurocysticercosis
Time Frame: 3 years
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
Factors determining outcomes in patients with parenchymal neurocysticercosis
Time Frame: 5 years
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
Factors determining outcomes in patients with extra-parenchymal neurocysticercosis
Time Frame: 1 year
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
Factors determining outcomes in patients with extra-parenchymal neurocysticercosis
Time Frame: 5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, New Delhi

Investigators

  • Principal Investigator: Ajay Garg, MD DM, All India Institute of Medical Sciences, New Delhi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 15, 2021

Primary Completion (ANTICIPATED)

December 31, 2025

Study Completion (ANTICIPATED)

December 31, 2025

Study Registration Dates

First Submitted

January 3, 2021

First Submitted That Met QC Criteria

January 9, 2021

First Posted (ACTUAL)

January 13, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 9, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEC-1176/04.12.2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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