Trial record 4 of 31 for:    Lyme disease | "Borrelia Infections"

Brain Imaging and Retreatment Study of Persistent Lyme Disease

This study has been completed.
Sponsor:
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier:
NCT00037479
First received: May 17, 2002
Last updated: December 6, 2005
Last verified: December 2005
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: PET and MRI Imaging of Persistent Lyme Encephalopathy

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00037479     History of Changes
Other Study ID Numbers: R01NS38636
Study First Received: May 17, 2002
Last Updated: December 6, 2005
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

Additional relevant MeSH terms:
Lyme Disease
Lyme Neuroborreliosis
Borrelia Infections
Tick-Borne Diseases
Central Nervous System Diseases
Nervous System Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Spirochaetales Infections
Central Nervous System Bacterial Infections
Central Nervous System Infections
Ceftriaxone
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014