Clinical Trial: Brain Imaging and Retreatment Study of Persistent Lyme Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: PET and MRI Imaging of Persistent Lyme Encephalopathy

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.

Detailed Summary:

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.

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Current Primary Outcome:

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Original Secondary Outcome:

Information By: National Institute of Neurological Disorders and Stroke (NINDS)

Dates:
Date Received: May 17, 2002
Date Started: December 1999
Date Completion:
Last Updated: December 6, 2005
Last Verified: December 2005