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Brain Imaging and Retreatment Study of Persistent Lyme Disease

Primary Purpose

Lyme Disease, Lyme Neuroborreliosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ceftriaxone
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lyme Disease focused on measuring neurologic Lyme disease, Lyme disease, ceftriaxone, Rocephin, PET scans, Lyme encephalopathy, neuroborreliosis, borreliosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Columbia Presbyterian Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 17, 2002
Last Updated
December 6, 2005
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00037479
Brief Title
Brain Imaging and Retreatment Study of Persistent Lyme Disease
Official Title
PET and MRI Imaging of Persistent Lyme Encephalopathy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lyme Disease, Lyme Neuroborreliosis
Keywords
neurologic Lyme disease, Lyme disease, ceftriaxone, Rocephin, PET scans, Lyme encephalopathy, neuroborreliosis, borreliosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
65 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ceftriaxone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Fallon, M.D.
Organizational Affiliation
Columbia University, College of Physicians and Surgeons, Lyme Disease Research Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.columbia-lyme.org
Description
Columbia's Lyme disease research studies website

Learn more about this trial

Brain Imaging and Retreatment Study of Persistent Lyme Disease

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