NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Natural History of Treated Neurocysticercosis and Long-Term Outcomes

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

85-I-0127

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 3 Years
Max Age: 99 Years

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Taenia Solium;
Neurocysticercosis;
Tapeworm;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Cysticercosis

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

The purpose of this study is to evaluate, treat and follow patients with cysticercosis, an infection with the larval form of the pork tapeworm, T. solium. When people ingest cysts of T. solium eggs, cysts develop in the muscles, brain and other organs. The cysts enlarge and cause inflammation, usually in the brain. Patients may develop seizures, headache, nausea, vomiting, inability to walk, poor vision due to enlargement of the brain, and increased pressure in the brain. Other neurological problems may develop depending on the location of the cysts. The drugs praziquantel and albendazole are used to treat cysticercosis, but it is not clear if these drugs are effective in all patients, such as those with calcified cysts or brain enlargement.

Patients with suspected or confirmed cysticercosis may be eligible for this study. Participants will be hospitalized for 2 to 3 weeks and will take either praziquantel or albendazole by mouth for 2 weeks. They may receive a corticosteroid to lessen the side effects of the drug therapy. Patients will be evaluated with medically indicated tests and procedures that may include:

- Blood tests.

- X-rays of the head and long bones.

- Electroencephalogram - recording of the electrical activity of the brain

- Lumbar puncture (spinal tap) - examination of the cerebrospinal fluid that bathes the brain and spinal cord. For this procedure, a local anesthetic is given and a needle is inserted in the space between the bones (vertebrae) in the lower back. About 2 tablespoons of fluid is collected through the needle.

- Eye examination.

- Magnetic resonance imaging (MRI) to examine the brain. MRI uses a strong magnetic field and radio waves instead of X-rays to demonstrate structural and chemical changes in the brain. During the scan, the patient lies on a table in a narrow cylinder (the scanner). He or she can speak with a staff member via an intercom system at all times during the procedure.

- Computed tomography (CT) to examine the brain. CT can be done from different angles and allows the doctor to view the brain in small sections in 3-dimensions. The patient lies on a table with the head positioned in the CT scanner.

Some of the tests may be repeated on the last day of therapy and at 3 and 6 months or longer after therapy.

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Eligibility

INCLUSION CRITERIA:

1. Patients ages 3 to 99 years.

2. Patients with proven or likely neurocysticercosis.

3. Willingness (of participant or legally authorized representative [LAR]) to sign consent and comply with study requirements.

EXCLUSION CRITERIA:

Not applicable.


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Citations:

Nash TE, Singh G, White AC, Rajshekhar V, Loeb JA, Proa(SqrRoot) o JV, Takayanagui OM, Gonzalez AE, Butman JA, DeGiorgio C, Del Brutto OH, Delgado-Escueta A, Evans CA, Gilman RH, Martinez SM, Medina MT, Pretell EJ, Teale J, Garcia HH. Treatment of neurocysticercosis: current status and future research needs. Neurology. 2006 Oct 10;67(7):1120-7.

Nash TE, Mahanty S, Garcia HH; Cysticercosis Group in Peru. Corticosteroid use in neurocysticercosis. Expert Rev Neurother. 2011 Aug;11(8):1175-83. doi: 10.1586/ern.11.86.

Nash TE, Garcia HH. Diagnosis and treatment of neurocysticercosis. Nat Rev Neurol. 2011 Sep 13;7(10):584-94. doi: 10.1038/nrneurol.2011.135. Review.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Elise M. O'Connell, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 04 BG RM 424
4 MEMORIAL DR
BETHESDA MD 20892
(301) 761-5413
oconnellem@mail.nih.gov

JeanAnne M. Ware, C.R.N.P.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 10 - CLINICAL CENTER BG RM 12C103
10 CENTER DR
BETHESDA MD 20892
(301) 594-3149
warejm@niaid.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT00001205

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NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Natural History of Treated Neurocysticercosis and Long-Term Outcomes

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

85-I-0127

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 3 Years
Max Age: 99 Years

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Taenia Solium;
Neurocysticercosis;
Tapeworm;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Cysticercosis

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

The purpose of this study is to evaluate, treat and follow patients with cysticercosis, an infection with the larval form of the pork tapeworm, T. solium. When people ingest cysts of T. solium eggs, cysts develop in the muscles, brain and other organs. The cysts enlarge and cause inflammation, usually in the brain. Patients may develop seizures, headache, nausea, vomiting, inability to walk, poor vision due to enlargement of the brain, and increased pressure in the brain. Other neurological problems may develop depending on the location of the cysts. The drugs praziquantel and albendazole are used to treat cysticercosis, but it is not clear if these drugs are effective in all patients, such as those with calcified cysts or brain enlargement.

Patients with suspected or confirmed cysticercosis may be eligible for this study. Participants will be hospitalized for 2 to 3 weeks and will take either praziquantel or albendazole by mouth for 2 weeks. They may receive a corticosteroid to lessen the side effects of the drug therapy. Patients will be evaluated with medically indicated tests and procedures that may include:

- Blood tests.

- X-rays of the head and long bones.

- Electroencephalogram - recording of the electrical activity of the brain

- Lumbar puncture (spinal tap) - examination of the cerebrospinal fluid that bathes the brain and spinal cord. For this procedure, a local anesthetic is given and a needle is inserted in the space between the bones (vertebrae) in the lower back. About 2 tablespoons of fluid is collected through the needle.

- Eye examination.

- Magnetic resonance imaging (MRI) to examine the brain. MRI uses a strong magnetic field and radio waves instead of X-rays to demonstrate structural and chemical changes in the brain. During the scan, the patient lies on a table in a narrow cylinder (the scanner). He or she can speak with a staff member via an intercom system at all times during the procedure.

- Computed tomography (CT) to examine the brain. CT can be done from different angles and allows the doctor to view the brain in small sections in 3-dimensions. The patient lies on a table with the head positioned in the CT scanner.

Some of the tests may be repeated on the last day of therapy and at 3 and 6 months or longer after therapy.

--Back to Top--

Eligibility

INCLUSION CRITERIA:

1. Patients ages 3 to 99 years.

2. Patients with proven or likely neurocysticercosis.

3. Willingness (of participant or legally authorized representative [LAR]) to sign consent and comply with study requirements.

EXCLUSION CRITERIA:

Not applicable.


--Back to Top--

Citations:

Nash TE, Singh G, White AC, Rajshekhar V, Loeb JA, Proa(SqrRoot) o JV, Takayanagui OM, Gonzalez AE, Butman JA, DeGiorgio C, Del Brutto OH, Delgado-Escueta A, Evans CA, Gilman RH, Martinez SM, Medina MT, Pretell EJ, Teale J, Garcia HH. Treatment of neurocysticercosis: current status and future research needs. Neurology. 2006 Oct 10;67(7):1120-7.

Nash TE, Mahanty S, Garcia HH; Cysticercosis Group in Peru. Corticosteroid use in neurocysticercosis. Expert Rev Neurother. 2011 Aug;11(8):1175-83. doi: 10.1586/ern.11.86.

Nash TE, Garcia HH. Diagnosis and treatment of neurocysticercosis. Nat Rev Neurol. 2011 Sep 13;7(10):584-94. doi: 10.1038/nrneurol.2011.135. Review.

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Elise M. O'Connell, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 04 BG RM 424
4 MEMORIAL DR
BETHESDA MD 20892
(301) 761-5413
oconnellem@mail.nih.gov

JeanAnne M. Ware, C.R.N.P.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 10 - CLINICAL CENTER BG RM 12C103
10 CENTER DR
BETHESDA MD 20892
(301) 594-3149
warejm@niaid.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT00001205

--Back to Top--