CysticercosisNCT00001912
Brain Tissue Swelling and Seizure Activity in Inactive Cysticercosis
An observational study of Cysticercosis and Cysts, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in 2 countries.
Trial summary
This study will examine what causes seizures in patients with cysticercosis (pork tapeworm infection). A better understanding of this could lead to improved methods of controlling or preventing seizures. In humans, the pork tapeworm (Taenia solium) lives in the small intestine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cysticercosis, Cysts, Seizures
- How many people
- 6 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Aug 1999to 4 Apr 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older. If children are evaluated they can be seen under the general protocol and they may be entered into the present protocol under an exception.
- Likely diagnosis of inactive cysticercosis and present or past seizure activity. Requires "a" and "b" plus any one of the remaining criteria:
- History of seizures or present seizure activity;
- Previously treated or has inactive disease and declines treatment;
- Single calcified lesions and positive serology;
- Multiple calcified lesions;
Show all 9Show fewer
- Multiple small enhancing nodular lesions;
- History of cystic lesions responding to specific chemotherapy.
- If female, not pregnant and using effective birth control methods.
Who cannot join
- Less than 18 years of age.
- Pregnant or unwilling to use effective birth control measures.
- Refuse blood tests.
- Unwilling or unable to undergo testing according to the schedule.
- Unable to undergo MRI or CT examinations.
- Patients who require anesthesia to undergo imaging studies.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Analysis of the Occurrence of Perilesional Edema and Seizures in Patients With Inactive Cysticercosis
This study will examine what causes seizures in patients with cysticercosis (pork tapeworm infection). A better understanding of this could lead to improved methods of controlling or preventing seizures.
In humans, the pork tapeworm (Taenia solium) lives in the small intestine. The parasite's microscopic eggs travel around the body-including to the brain-where they develop into cysts. Usually, the cysts don't cause symptoms until they die. Then, they provoke an inflammatory reaction that irritates the brain, causing seizures and other symptoms. The inflammation eventually goes away, but the dead cysts remain. Calcium deposits often form where the cysts are. Some of the calcified cysts develop swelling around them that seem to be associated with the development of seizures.
Read more
This study will explore how and why these dead, calcified cysts continue to cause seizures. In so doing, it will try to determine: 1) the best diagnostic imaging method for detecting swelling around the cysts; 2) how often swelling occurs; and 3) what makes some cysts prone to swelling and related seizure activity, while others are not.
Patients with cysticercosis who have had seizures or who have known or possible swelling around calcified cysts will be studied with various tests, including magnetic resonance imaging (MRI), computed tomography (CT) scans, electroencephalography (EEG), blood tests, and possibly lumbar puncture. Patients will be studied for two cycles of seizures (during active and quiet periods) or a maximum 4 years.
Read the detailed description
Seizures are the most common clinical manifestation of cerebral cysticercosis and occur in the presence of viable, dying, and calcified or non-calcified dead cysts. How calcified cysts provoke seizures is not known but recent observations demonstrated edema around some calcified lesions at the time of seizure activity and disappearance during periods when seizures were not occurring. Edema associated with foci in idiopathic epilepsy is highly unusual so that this observation suggests that the mechanism(s) associated with calcified cysts is unique. Documenting and understanding this phenomenon is important for a number of reasons. First, although by definition these lesions are inactive, e.g., not living larvae and do not require anti-parasitic treatment, they are frequently mistaken for active lesions and patients undergo unnecessary treatment. Second, a likely reason for perilesional edema is intermittent antigen release and subsequent host immune response resulting in inflammation and edema. If proved, then the treatment for this would not only involve suppression of seizure activity with anti-seizure medication but also the use of anti-inflammatory medications such as corticosteroids. The present protocol will systematically assess the presence of edema associated with calcified lesions at the time of seizure activity and attempt to determine why some calcified lesions in the same patient are foci of seizures while others are clinically silent. There are three related but separate questions. 1) What is the most sensitive MRI technique that can detect edema around calcified or inactive lesions? It is essential to determine the most sensitive methods initially because the use of insensitive techniques will lead to inaccurate assessments of which lesions are prone to lead to seizure activity and how many patients are affected. 2) How common is perilesional edema around calcified or inactive lesions associated with seizure activity? 3) What factors determine which lesions are prone to cause seizure activity? 4) Can perilesional edema be effectively treated or prevented? 5) Can perilesional edema be treated? We have reported from long term longitudinal studies in a handful of patients that only some of many lesions seem to be associated with seizure activity and edema.
- Conditions
- Cysticercosis, Cysts, Seizures
- Keywords
- Cysticercosis, T. Solium, MRI, Seizures, Calcified Cysts, Taenia
- Medical subject headings
- Cysticercosis, Cysts, Seizures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start10 Aug 1999
- Study completion4 Apr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CysticercosisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Henry Masur, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001912
- Sponsor's protocol ID
- 990149
- Other IDs
- 99-I-0149
- Status last verified
- 4 Apr 2012
- First submitted
- 3 Nov 1999
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
White AC Jr. Neurocysticercosis: a major cause of neurological disease worldwide. Clin Infect Dis. 1997 Feb;24(2):101-13; quiz 114-5. doi: 10.1093/clinids/24.2.101. No abstract available.
PubMed 9114131Rajshekhar V, Chacko G, Haran RP, Chandy MJ, Chandi SM. Clinicoradiological and pathological correlations in patients with solitary cysticercus granuloma and epilepsy: focus on presence of the parasite and oedema formation. J Neurol Neurosurg Psychiatry. 1995 Sep;59(3):284-6. doi: 10.1136/jnnp.59.3.284.
PubMed 7673957Nash TE, Neva FA. Recent advances in the diagnosis and treatment of cerebral cysticercosis. N Engl J Med. 1984 Dec 6;311(23):1492-6. doi: 10.1056/NEJM198412063112307. No abstract available.
PubMed 6390196
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Occurrence of Perilesional Edema and Seizures in Patients With Inactive Cysticercosis
- ClinicalTrials.gov ID
- NCT00001912
- Acronym / sponsor ID
- 990149
- Conditions
- Cysticercosis, Cysts, Seizures
- Keywords
- Cysticercosis, T. Solium, MRI, Seizures, Calcified Cysts, Taenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 10 Aug 1999
- Study completion
- 4 Apr 2012
- First posted
- 4 Nov 1999 (estimated)
- 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.
This study will examine what causes seizures in patients with cysticercosis (pork tapeworm infection). A better understanding of this could lead to improved methods of controlling or preventing seizures.
In humans, the pork tapeworm (Taenia solium) lives in the small intestine. The parasite's microscopic eggs travel around the body-including to the brain-where they develop into cysts. Usually, the cysts don't cause symptoms until they die. Then, they provoke an inflammatory reaction that irritates the brain, causing seizures and other symptoms. The inflammation eventually goes away, but the dead cysts remain. Calcium deposits often form where the cysts are. Some of the calcified cysts develop swelling around them that seem to be associated with the development of seizures.
This study will explore how and why these dead, calcified cysts continue to cause seizures. In so doing, it will try to determine: 1) the best diagnostic imaging method for detecting swelling around the cysts; 2) how often swelling occurs; and 3) what makes some cysts prone to swelling and related seizure activity, while others are not.
Patients with cysticercosis who have had seizures or who have known or possible swelling around calcified cysts will be studied with various tests, including magnetic resonance imaging (MRI), computed tomography (CT) scans, electroencephalography (EEG), blood tests, and possibly lumbar puncture. Patients will be studied for two cycles of seizures (during active and quiet periods) or a maximum 4 years.
Detailed description
Seizures are the most common clinical manifestation of cerebral cysticercosis and occur in the presence of viable, dying, and calcified or non-calcified dead cysts. How calcified cysts provoke seizures is not known but recent observations demonstrated edema around some calcified lesions at the time of seizure activity and disappearance during periods when seizures were not occurring. Edema associated with foci in idiopathic epilepsy is highly unusual so that this observation suggests that the mechanism(s) associated with calcified cysts is unique. Documenting and understanding this phenomenon is important for a number of reasons. First, although by definition these lesions are inactive, e.g., not living larvae and do not require anti-parasitic treatment, they are frequently mistaken for active lesions and patients undergo unnecessary treatment. Second, a likely reason for perilesional edema is intermittent antigen release and subsequent host immune response resulting in inflammation and edema. If proved, then the treatment for this would not only involve suppression of seizure activity with anti-seizure medication but also the use of anti-inflammatory medications such as corticosteroids. The present protocol will systematically assess the presence of edema associated with calcified lesions at the time of seizure activity and attempt to determine why some calcified lesions in the same patient are foci of seizures while others are clinically silent. There are three related but separate questions. 1) What is the most sensitive MRI technique that can detect edema around calcified or inactive lesions? It is essential to determine the most sensitive methods initially because the use of insensitive techniques will lead to inaccurate assessments of which lesions are prone to lead to seizure activity and how many patients are affected. 2) How common is perilesional edema around calcified or inactive lesions associated with seizure activity? 3) What factors determine which lesions are prone to cause seizure activity? 4) Can perilesional edema be effectively treated or prevented? 5) Can perilesional edema be treated? We have reported from long term longitudinal studies in a handful of patients that only some of many lesions seem to be associated with seizure activity and edema.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years of age or older. If children are evaluated they can be seen under the general protocol and they may be entered into the present protocol under an exception.
- Likely diagnosis of inactive cysticercosis and present or past seizure activity. Requires "a" and "b" plus any one of the remaining criteria:
- History of seizures or present seizure activity;
- Previously treated or has inactive disease and declines treatment;
- Single calcified lesions and positive serology;
Key exclusion criteria (6 listed)
- Less than 18 years of age.
- Pregnant or unwilling to use effective birth control measures.
- Refuse blood tests.
- Unwilling or unable to undergo testing according to the schedule.
- Unable to undergo MRI or CT examinations.
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 9114131White AC Jr. Neurocysticercosis: a major cause of neurological disease worldwide. Clin Infect Dis. 1997 Feb;24(2):101-13; quiz 114-5. doi: 10.1093/clinids/24.2.101. No abstract available.
- Background: PubMed 7673957Rajshekhar V, Chacko G, Haran RP, Chandy MJ, Chandi SM. Clinicoradiological and pathological correlations in patients with solitary cysticercus granuloma and epilepsy: focus on presence of the parasite and oedema formation. J Neurol Neurosurg Psychiatry. 1995 Sep;59(3):284-6. doi: 10.1136/jnnp.59.3.284.
- Background: PubMed 6390196Nash TE, Neva FA. Recent advances in the diagnosis and treatment of cerebral cysticercosis. N Engl J Med. 1984 Dec 6;311(23):1492-6. doi: 10.1056/NEJM198412063112307. No abstract available.
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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.
Henry Masur, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cysticercosis and Cysts, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in 2 countries.
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 9 inclusion and 6 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: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001912, which also lists 3 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 2 Jul 2017.