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Home > "B" Clinical Trials Conditions > Brain Imaging and Retreatment Study of Persistent Lyme Disease  Brain Imaging and Retreatment Study of Persistent Lyme Disease
Brain Imaging and Retreatment Study of Persistent Lyme Disease
For Condition: Lyme Neuroborreliosis,Lyme Disease
Status: Recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional,Treatment,Randomized,Placebo Control
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Eligible participants must be 18-65 years old and have persistent problems with memory, verbal fluency, or attention after having contracted Lyme disease. Participants must 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. Participants must have had a history of well-documented Lyme disease using the CDC's clinical criteria and a current positive IgG Western blot or PCR. Participants must also have received, at some point in the past at least 3 weeks of IV antibiotic therapy for Lyme disease. Ineligible from participation are people with other major medical or neurologic problems, people who smoke more than 10 cigarettes a day, people with uncontrolled high blood pressure, people with allergy to ceftriaxone (Rocephin), and people who have a history of marked cocaine abuse. Twenty healthy subjects are also being sought for the study.
Total Enrollment: 65
Location and Contact Information:
Overall Study Official:
BrianFallon, Principal Investigator, Columbia University, College of Physicians and Surgeons, Lyme Disease Research Program
Columbia Presbyterian Medical Center *Recruiting*
New York City, New York, 10032
United States
Recruiting Megan Romano 212-543-6510
Additional Information:
Study ID Numbers: R01NS38636;
Study Start Date: December 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00037479
Other Lyme Disease Studies:
1. Brain Imaging and Retreatment Study of Persistent Lyme Disease
Related Studies:
Other Lyme Disease Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Brain Imaging and Retreatment Study of Persistent Lyme Disease
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