Parenchymal and Extraparenchymal Neurocysticercosis-A Registry Based Study

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04706819
• Other study ID #: IEC-1176/04.12.2020
• Status: Not yet recruiting
• Start date: January 15, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2021
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: Arunmozhimaran Elavarasi, MD DM
• Phone: +919013844274
• Email: arun_ela[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cysticercosis
• Neurocysticercosis
• Tenia Solium Infection
• Tropical Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

References & Publications (21)

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. Review. — View Citation

Amaral L, Maschietto M, Maschietto R, Cury R, Ferreira NF, Mendonça R, Lima SS. Ununsual manifestations of neurocysticercosis in MR imaging: analysis of 172 cases. Arq Neuropsiquiatr. 2003 Sep;61(3A):533-41. Epub 2003 Sep 16. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Moyano LM, Saito M, Montano SM, Gonzalvez G, Olaya S, Ayvar V, González I, Larrauri L, Tsang VC, Llanos F, Rodríguez 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. — View Citation

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

Proaño JV, Torres-Corzo J, Rodríguez-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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Erratum in: AJNR Am J Neuroradiol 2000 Sep;21(8):1565. Pilon, L [corrected to Pillon, L]. — View Citation

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. Review. — View Citation

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. Epub 2007 Nov 10. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

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