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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.
 
ClinicalTrials.gov Identifier: NCT00037479
Recruitment Status : Completed
First Posted : May 20, 2002
Last Update Posted : December 7, 2005
Sponsor:
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)

Tracking Information
First Submitted Date  ICMJE May 17, 2002
First Posted Date  ICMJE May 20, 2002
Last Update Posted Date December 7, 2005
Study Start Date  ICMJE December 1999
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00037479 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brain Imaging and Retreatment Study of Persistent Lyme Disease
Official Title  ICMJE 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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE
  • Lyme Disease
  • Lyme Neuroborreliosis
Intervention  ICMJE Drug: ceftriaxone
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
65
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00037479
Other Study ID Numbers  ICMJE R01NS038636( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brian Fallon, M.D. Columbia University, College of Physicians and Surgeons, Lyme Disease Research Program
PRS Account National Institute of Neurological Disorders and Stroke (NINDS)
Verification Date December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP