NeurocysticercosisNCT04706819
Parenchymal and Extraparenchymal Neurocysticercosis-A Registry Based Study
An observational study of Neurocysticercosis and Tropical Disease, run by All India Institute of Medical Sciences.
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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Neurocysticercosis, Tropical Disease, Tenia Solium Infection
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2021to 31 Dec 2025
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study Population: Patients with MRI/CT diagnosed neurocysticercosis as per composite clinical criteria, imaging criteria as well as natural history
Who may be able to join
- 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.
Who cannot join
- Not willing to provide consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neurocysticercosis, Tropical Disease, Tenia Solium Infection
- Keywords
- Parenchymal Neurocysticercosis, Extraparenchmal Neurocysticercosis, Intraventricular neurocysticercosis, Racemose neurocysticercosis
- Medical subject headings
- Neurocysticercosis, Taeniasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical features in patients with parenchymal and extraparenchymal neurocysticercosis
To study the clinical features in patients with parenchymal and extraparenchymal neurocysticercosis
Measured: 6 months
Laboratory features
To study the hematologic and CSF parameters in patients with parenchymal and extraparenchymal neurocysticercosis
Measured: 6 months
Imaging features
To study the imaging features in patients with parenchymal and extraparenchymal neurocysticercosis
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 5 years
Extra-parenchymal neurocysticercosis
To find the proportion of patients having extra-parenchymal neurocysticercosis
Measured: 6 months
Secondary outcomes (5)
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
Measured: 1 year
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
Measured: 3 years
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
Measured: 5 years
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
Measured: 1 year
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start15 Jan 2021 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for NeurocysticercosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arunmozhimaran Elavarasi, All India Institute of Medical Sciences
- Investigators
- Arunmozhimaran Elavarasi, MD DM, Principal investigator, All India Institute of Medical SciencesAjay Garg, MD DM, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706819
- Sponsor's protocol ID
- IEC-1176/04.12.2020
- Status last verified
- Jan 2021
- First submitted
- 3 Jan 2021
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25453460White 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.
PubMed 29481580Rajshekhar 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.
PubMed 30038069Rajshekhar 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.
PubMed 17190933Moyano 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.
PubMed 24551255Garcia 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.
PubMed 24999157Nash 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.
PubMed 18986841Ooi 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.
PubMed 21896805Sheth 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.
PubMed 9432161Amaral 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.
PubMed 14513153Huang 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.
PubMed 31314709Martinez 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.
PubMed 2505513Abba 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.
PubMed 20091504Garcia 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.
PubMed 14724304Nash 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.
PubMed 29692305
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Laboratory and Imaging Features, Treatment Trends and Long Term Outcomes in Patients With Parenchymal and Extraparenchymal Neurocysticercosis-A Registry Based Study
- ClinicalTrials.gov ID
- NCT04706819
- Acronym / sponsor ID
- IEC-1176/04.12.2020
- Conditions
- Neurocysticercosis, Tropical Disease, Tenia Solium Infection
- Keywords
- Parenchymal Neurocysticercosis, Extraparenchmal Neurocysticercosis, Intraventricular neurocysticercosis, Racemose neurocysticercosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- 15 Jan 2021 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study Population: Patients with MRI/CT diagnosed neurocysticercosis as per composite clinical criteria, imaging criteria as well as natural history
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Not willing to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Laboratory features
Time frame: 6 months
To study the hematologic and CSF parameters in patients with parenchymal and extraparenchymal neurocysticercosis
Imaging features
Time frame: 6 months
To study the imaging features in patients with parenchymal and extraparenchymal neurocysticercosis
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
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
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
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
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
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
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
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
Extra-parenchymal neurocysticercosis
Time frame: 6 months
To find the proportion of patients having extra-parenchymal neurocysticercosis
5 secondary outcomes
Factors determining outcomes in patients with parenchymal neurocysticercosis
Time frame: 1 year
Factors determining outcomes in patients with parenchymal neurocysticercosis
Time frame: 3 years
Factors determining outcomes in patients with parenchymal neurocysticercosis
Time frame: 5 years
Factors determining outcomes in patients with extra-parenchymal neurocysticercosis
Time frame: 1 year
Factors determining outcomes in patients with extra-parenchymal neurocysticercosis
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Background: PubMed 25453460Garcia 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.
- Background: PubMed 29481580White 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.
- Background: PubMed 30038069Rajshekhar 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.
- Background: PubMed 17190933Rajshekhar 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.
- Background: PubMed 24551255Moyano 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.
- Background: PubMed 24999157Garcia 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.
- Background: PubMed 18986841Nash 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.
- Background: PubMed 21896805Ooi 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.
- Background: PubMed 9432161Sheth 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.
- Background: PubMed 14513153Amaral 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.
- Background: PubMed 31314709Huang 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.
- Background: PubMed 2505513Martinez 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arunmozhimaran Elavarasi, MD DM principal investigator
All India Institute of Medical Sciences
Ajay Garg, MD DM principal investigator
All India Institute of Medical Sciences
Questions about this trial
What is this clinical trial studying?
An observational study of Neurocysticercosis and Tropical Disease, run by All India Institute of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arunmozhimaran Elavarasi, MD DM (+919013844274, arun_ela@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical features in patients with parenchymal and extraparenchymal neurocysticercosis (time frame: 6 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04706819, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.