NCT00001912

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 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 1999

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 1999

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
12.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2012

Completed
Last Updated

July 2, 2017

Status Verified

April 4, 2012

First QC Date

November 3, 1999

Last Update Submit

June 30, 2017

Conditions

Keywords

CysticercosisT. SoliumMRISeizuresCalcified CystsTaenia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Universidad Peruana Cayetano Heredia

Lima, Peru

Location

Related Publications (3)

  • 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.

    PMID: 9114131BACKGROUND
  • 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.

    PMID: 7673957BACKGROUND
  • 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.

    PMID: 6390196BACKGROUND

MeSH Terms

Conditions

CysticercosisCystsSeizures

Condition Hierarchy (Ancestors)

TaeniasisCestode InfectionsHelminthiasisParasitic DiseasesInfectionsNeoplasmsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Study Officials

  • Henry Masur, M.D.

    National Institutes of Health Clinical Center (CC)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

August 10, 1999

Study Completion

April 4, 2012

Last Updated

July 2, 2017

Record last verified: 2012-04-04

Locations