- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001912
Brain Tissue Swelling and Seizure Activity in Inactive Cysticercosis
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.
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Lima, Peru
- Universidad Peruana Cayetano Heredia
-
-
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
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;
- Multiple small enhancing nodular lesions;
- History of cystic lesions responding to specific chemotherapy.
If female, not pregnant and using effective birth control methods.
EXCLUSION CRITERIA:
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.
Study Plan
How is the study designed?
Collaborators and Investigators
Investigators
- Principal Investigator: Henry Masur, M.D., National Institutes of Health Clinical Center (CC)
Publications and helpful links
General 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.
- Rajshekhar 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.
- Nash 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Infections
- Neurologic Manifestations
- Central Nervous System Infections
- Parasitic Diseases
- Helminthiasis
- Cestode Infections
- Central Nervous System Helminthiasis
- Central Nervous System Parasitic Infections
- Seizures
- Cysticercosis
- Taeniasis
- Neurocysticercosis
Other Study ID Numbers
- 990149
- 99-I-0149
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cysts
-
Qassim UniversityAl-Azhar UniversityRecruiting
-
Al-Azhar UniversityActive, not recruiting
-
Radwa Hydar RagabNot yet recruiting
-
Ain Shams UniversityRecruiting
-
Semmelweis UniversityRecruitingOdontogenic CystsHungary
-
University of BelgradeEnrolling by invitationOdontogenic KeratocystSerbia
-
Alexandria UniversityCompleted
-
University Hospital, MontpellierEnrolling by invitation
-
Sophia Al-AdwanUnknownAneurysmal Bone CystJordan
-
Arthrex, Inc.Recruiting