Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001912
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
1999-11-03
Brief Title:
Brain Tissue Swelling and Seizure Activity in Inactive Cysticercosis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Analysis of the Occurrence of Perilesional Edema and Seizures in Patients With Inactive Cysticercosis
Status:
COMPLETED
Status Verified Date:
2012-04-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 The parasites microscopic eggs travel around the body-including to the brain-where they develop into cysts Usually the cysts dont 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
In humans the pork tapeworm Taenia solium lives in the small intestine The parasites microscopic eggs travel around the body-including to the brain-where they develop into cysts Usually the cysts dont 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 mechanisms 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-I-0149 | None | None | None |