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Brain Imaging and Retreatment Study of Persistent Lyme Disease

This study has been completed.

Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT00037479
  Purpose

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 Intervention Phase
Lyme Disease
Lyme Neuroborreliosis
Drug: ceftriaxone
Phase II

MedlinePlus related topics:   Lyme Disease   

Drug Information available for:   Ceftriaxone    Ceftriaxone Sodium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Placebo Control
Official Title:   PET and MRI Imaging of Persistent Lyme Encephalopathy

Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Estimated Enrollment:   65
Study Start Date:   December 1999

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.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00037479

Locations
United States, New York
Columbia Presbyterian Medical Center    
      New York, New York, United States, 10032

Sponsors and Collaborators

Investigators
Principal Investigator:     Brian Fallon, M.D.     Columbia University, College of Physicians and Surgeons, Lyme Disease Research Program    
  More Information


Columbia's Lyme disease research studies website  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   R01NS38636
First Received:   May 17, 2002
Last Updated:   December 6, 2005
ClinicalTrials.gov Identifier:   NCT00037479
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
neurologic Lyme disease  
Lyme disease  
ceftriaxone  
Rocephin  
PET scans
Lyme encephalopathy
neuroborreliosis
borreliosis

Study placed in the following topic categories:
Bacterial Infections
Central Nervous System Infections
Borrelia Infections
Borreliosis
Lyme Disease
Central Nervous System Diseases
Lyme Neuroborreliosis
Ceftriaxone
Tick-Borne Diseases
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Spirochaetales Infections
Therapeutic Uses
Nervous System Diseases
Central Nervous System Bacterial Infections
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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