Parenchymal and Extraparenchymal Neurocysticercosis-A Registry Based Study

NCT04706819 | Unknown

• 1 other identifier: IEC-1176/04.12.2020
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neurocysticercosis; Tropical Disease; Tenia Solium Infection

Keywords

Parenchymal Neurocysticercosis; Extraparenchmal Neurocysticercosis; Intraventricular neurocysticercosis; Racemose neurocysticercosis

Outcome Measures

Primary Outcomes (12)

• Clinical features in patients with parenchymal and extraparenchymal neurocysticercosis

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

  6 months

• Laboratory features

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

  6 months

• Imaging features

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

  6 months

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Extra-parenchymal neurocysticercosis

  To find the proportion of patients having extra-parenchymal neurocysticercosis

  6 months

Secondary Outcomes (5)

• Factors determining outcomes in patients with parenchymal neurocysticercosis

  1 year

• Factors determining outcomes in patients with parenchymal neurocysticercosis

  3 years

• Factors determining outcomes in patients with parenchymal neurocysticercosis

  5 years

• Factors determining outcomes in patients with extra-parenchymal neurocysticercosis

  1 year

• Factors determining outcomes in patients with extra-parenchymal neurocysticercosis

  5 years

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Not willing to provide consent

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Related Publications (21)

• Garcia HH, Nash TE, Del Brutto OH. Clinical symptoms, diagnosis, and treatment of neurocysticercosis. Lancet Neurol. 2014 Dec;13(12):1202-15. doi: 10.1016/S1474-4422(14)70094-8. Epub 2014 Nov 10.

  PMID: 25453460 BACKGROUND

• White AC Jr, Coyle CM, Rajshekhar V, Singh G, Hauser WA, Mohanty A, Garcia HH, Nash TE. Diagnosis and Treatment of Neurocysticercosis: 2017 Clinical Practice Guidelines by the Infectious Diseases Society of America (IDSA) and the American Society of Tropical Medicine and Hygiene (ASTMH). Clin Infect Dis. 2018 Apr 3;66(8):e49-e75. doi: 10.1093/cid/cix1084. No abstract available.

  PMID: 29481580 BACKGROUND

• Rajshekhar V. Evolution of concepts in the management of cysticercosis of the brain: Then (1970) and now (2018). Neurol India. 2018 Jul-Aug;66(4):919-927. doi: 10.4103/0028-3886.236969. No abstract available.

  PMID: 30038069 BACKGROUND

• Rajshekhar V, Raghava MV, Prabhakaran V, Oommen A, Muliyil J. Active epilepsy as an index of burden of neurocysticercosis in Vellore district, India. Neurology. 2006 Dec 26;67(12):2135-9. doi: 10.1212/01.wnl.0000249113.11824.64.

  PMID: 17190933 BACKGROUND

• Moyano LM, Saito M, Montano SM, Gonzalvez G, Olaya S, Ayvar V, Gonzalez I, Larrauri L, Tsang VC, Llanos F, Rodriguez S, Gonzalez AE, Gilman RH, Garcia HH; Cysticercosis Working Group in Peru. Neurocysticercosis as a cause of epilepsy and seizures in two community-based studies in a cysticercosis-endemic region in Peru. PLoS Negl Trop Dis. 2014 Feb 13;8(2):e2692. doi: 10.1371/journal.pntd.0002692. eCollection 2014 Feb.

  PMID: 24551255 BACKGROUND

• Garcia HH, Gonzales I, Lescano AG, Bustos JA, Zimic M, Escalante D, Saavedra H, Gavidia M, Rodriguez L, Najar E, Umeres H, Pretell EJ; Cysticercosis Working Group in Peru. Efficacy of combined antiparasitic therapy with praziquantel and albendazole for neurocysticercosis: a double-blind, randomised controlled trial. Lancet Infect Dis. 2014 Aug;14(8):687-695. doi: 10.1016/S1473-3099(14)70779-0. Epub 2014 Jul 3.

  PMID: 24999157 BACKGROUND

• 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.

  PMID: 18986841 BACKGROUND

• 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.

  PMID: 21896805 BACKGROUND

• Sheth TN, Pillon L, Keystone J, Kucharczyk W. Persistent MR contrast enhancement of calcified neurocysticercosis lesions. AJNR Am J Neuroradiol. 1998 Jan;19(1):79-82.

  PMID: 9432161 BACKGROUND

• Amaral L, Maschietto M, Maschietto R, Cury R, Ferreira NF, Mendonca R, Lima SS. Ununsual manifestations of neurocysticercosis in MR imaging: analysis of 172 cases. Arq Neuropsiquiatr. 2003 Sep;61(3A):533-41. doi: 10.1590/s0004-282x2003000400002. Epub 2003 Sep 16.

  PMID: 14513153 BACKGROUND

• Huang X, Wang Z, Kou J, Liu H, Mao D, Yu Z, Liu X, Cheng P, Gong M. A Large Cohort of Neurocysticercosis in Shandong Province, Eastern China, 1997-2015. Vector Borne Zoonotic Dis. 2019 Dec;19(12):901-907. doi: 10.1089/vbz.2019.2447. Epub 2019 Jul 17.

  PMID: 31314709 BACKGROUND

• Martinez HR, Rangel-Guerra R, Elizondo G, Gonzalez J, Todd LE, Ancer J, Prakash SS. MR imaging in neurocysticercosis: a study of 56 cases. AJNR Am J Neuroradiol. 1989 Sep-Oct;10(5):1011-9.

  PMID: 2505513 BACKGROUND

• Abba K, Ramaratnam S, Ranganathan LN. Anthelmintics for people with neurocysticercosis. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD000215. doi: 10.1002/14651858.CD000215.pub3.

  PMID: 20091504 BACKGROUND

• Garcia HH, Pretell EJ, Gilman RH, Martinez SM, Moulton LH, Del Brutto OH, Herrera G, Evans CA, Gonzalez AE; Cysticercosis Working Group in Peru. A trial of antiparasitic treatment to reduce the rate of seizures due to cerebral cysticercosis. N Engl J Med. 2004 Jan 15;350(3):249-58. doi: 10.1056/NEJMoa031294.

  PMID: 14724304 BACKGROUND

• 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.

  PMID: 29692305 BACKGROUND

• Sinha S, Sharma BS. Intraventricular neurocysticercosis: a review of current status and management issues. Br J Neurosurg. 2012 Jun;26(3):305-9. doi: 10.3109/02688697.2011.635820. Epub 2011 Dec 15.

  PMID: 22168964 BACKGROUND

• Suri A, Goel RK, Ahmad FU, Vellimana AK, Sharma BS, Mahapatra AK. Endoscopic excision of intraventricular neurocysticercosis in children: a series of six cases and review. Childs Nerv Syst. 2008 Feb;24(2):281-5. doi: 10.1007/s00381-007-0462-y. Epub 2007 Nov 10.

  PMID: 17994242 BACKGROUND

• Suri A, Goel RK, Ahmad FU, Vellimana AK, Sharma BS, Mahapatra AK. Transventricular, transaqueductal scope-in-scope endoscopic excision of fourth ventricular neurocysticercosis: a series of 13 cases and a review. J Neurosurg Pediatr. 2008 Jan;1(1):35-9. doi: 10.3171/PED-08/01/035.

  PMID: 18352801 BACKGROUND

• Sharma BS, Sawarkar DP, Verma SK. Endoscopic Management of Fourth Ventricle Neurocysticercosis: Description of the New Technique in a Case Series of 5 Cases and Review of the Literature. World Neurosurg. 2019 Feb;122:e647-e654. doi: 10.1016/j.wneu.2018.10.117. Epub 2018 Oct 26.

  PMID: 30814022 BACKGROUND

• Proano JV, Torres-Corzo J, Rodriguez-Della Vecchia R, Guizar-Sahagun G, Rangel-Castilla L. Intraventricular and subarachnoid basal cisterns neurocysticercosis: a comparative study between traditional treatment versus neuroendoscopic surgery. Childs Nerv Syst. 2009 Nov;25(11):1467-75. doi: 10.1007/s00381-009-0933-4. Epub 2009 Jun 26.

  PMID: 19557421 BACKGROUND

• 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.

  PMID: 31642423 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood and CSF

MeSH Terms

Conditions

Neurocysticercosis; Taeniasis

Condition Hierarchy (Ancestors)

Central Nervous System Helminthiasis; Central Nervous System Parasitic Infections; Central Nervous System Infections; Infections; Parasitic Diseases; Cysticercosis; Cestode Infections; Helminthiasis; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Arunmozhimaran Elavarasi, MD DM

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Ajay Garg, MD DM

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arunmozhimaran Elavarasi, MD DM

CONTACT

+919013844274; arun_ela@yahoo.com

Ajay Garg, MD DM

CONTACT

+919868240050; drajaygarg@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Neurology

Study Record Dates

• First Submitted: January 3, 2021
• First Posted: January 13, 2021
• Study Start: January 15, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 13, 2021

Record last verified: 2021-01