Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037479
Status:
COMPLETED
Last Update Posted:
2005-12-07
First Post:
2002-05-17
Brief Title:
Brain Imaging and Retreatment Study of Persistent Lyme Disease
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institute of Neurological Disorders and Stroke NINDS
Study Overview
Official Title:
PET and MRI Imaging of Persistent Lyme Encephalopathy
Status:
COMPLETED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 patients home Patients will be screened over the phone and in person to confirm study eligibility
This 24-week treatment study will evaluate each patients 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 patients home Patients will be screened over the phone and in person to confirm study eligibility
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: