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Brain Imaging and Retreatment Study of Persistent Lyme Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00037479
Recruitment Status : Completed
First Posted : May 20, 2002
Last Update Posted : December 7, 2005
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)

Brief Summary:
The purpose of this study is to determine whether patients with persistent memory problems after Lyme disease benefit from an additional longer course of IV antibiotic therapy; to use modern brain imaging technology to determine whether the problem in the central nervous system is primarily one of poor blood flow or one of impaired nerve cell functioning; and to try to identify biological markers prior to treatment that will identify patients who are more or less likely to respond to the study treatment.

Condition or disease Intervention/treatment Phase
Lyme Disease Lyme Neuroborreliosis Drug: ceftriaxone Phase 2

Detailed Description:

Some people with a history of Lyme disease continue to have problems despite having received "textbook duration" antibiotic therapy. When memory, attention, or thinking problems persist, the syndrome is called persistent Lyme disease (PLD). This study seeks to answer critical scientific questions about the treatment and cause of PLD symptoms.

This 24-week treatment study will evaluate each patient's response to treatment using neuropsychological testing and state-of-the-art brain imaging. The brain tests include neuropsychological testing of memory and attention, brain imaging (MRI and PET scans) to look at blood flow in the brain and nerve cell structure and metabolism, a neurological exam, and studies of the fluid that surrounds the brain (cerebrospinal fluid). The treatment involves 10 weeks of either intravenous antibiotic called ceftriaxone (also known as Rocephin) or intravenous placebo (inactive substance). After the first visit to Columbia Presbyterian Medical Center, the remaining treatments will be done in the patient's home. Patients will be screened over the phone and in person to confirm study eligibility.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 65 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: PET and MRI Imaging of Persistent Lyme Encephalopathy
Study Start Date : December 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Eligible participants must:

  • Be 18-65 years old
  • Have persistent problems with memory, verbal fluency, or attention after having contracted Lyme disease.
  • Be able to travel to New York for 4-5 evaluations over the course of one year. Travel costs for participants in need may be partially or fully reimbursable.
  • Have had a history of well-documented Lyme disease using the CDC's clinical criteria and a current positive IgG Western blot or PCR.
  • Have received, at some point in the past at least 3 weeks of IV antibiotic therapy for Lyme disease.

Exclusion Criteria:

Ineligible from participation are people with the following:

  • Other major medical or neurologic problems
  • Smoke more than 10 cigarettes a day
  • Uncontrolled high blood pressure
  • Allergy to ceftriaxone (Rocephin)
  • History of marked cocaine abuse

Twenty healthy subjects are also being sought for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00037479

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United States, New York
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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Principal Investigator: Brian Fallon, M.D. Columbia University, College of Physicians and Surgeons, Lyme Disease Research Program
Additional Information:
Layout table for additonal information Identifier: NCT00037479    
Other Study ID Numbers: R01NS038636 ( U.S. NIH Grant/Contract )
First Posted: May 20, 2002    Key Record Dates
Last Update Posted: December 7, 2005
Last Verified: December 2005
Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
neurologic Lyme disease
Lyme disease
PET scans
Lyme encephalopathy
Additional relevant MeSH terms:
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Lyme Disease
Lyme Neuroborreliosis
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections
Central Nervous System Bacterial Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Anti-Bacterial Agents
Anti-Infective Agents