A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations

Exclusion Criteria

• •1. Age less than 18 (less than 13 for patients with PTLDS)
• •2. Weight less than 70 Lb. (35 kg)
• •3. Pregnancy or lactation
• •4. Women with childbearing potential who are sexually active with a male partner and unwilling to use effective contraception during the evaluation and treatment phases of the protocol.
• •5. Clinically significant laboratory abnormalities including positive test for syphilis (RPR), HBsAg, anti-HCV, anti-HIV.
• •6. Chronic medication use will be evaluated in a case-by-case basis.
• •7. Not able to understand all of the requirements of the study or unable to give informed consent and/or comply with all aspects of the evaluation.
• •8. All study participants must agree to allow their samples to be used for future research.
• •1. Use of immunosuppressive drugs such as systemic (but not topical or inhalant) steroids and cytotoxic agents.
• •2. History of any recognized autoimmune disease such as rheumatoid arthritis, vasculitis, systemic erythematous lupus, etc.
• •3. Serious pre-existing or concurrent chronic medical or psychiatric illnesses other than Lyme disease.
• •4. Past history of significant head trauma, alcohol or substance abuse in the past 5 years or other medical illness that might produce neurologic deficit (such as cerebrovascular disease).
• •5. Use of systemic antibiotics in the previous month.
• •6. Use of immunomodulators such as interferons.
• •7. Chronic medication use will be evaluated in a case-by-case basis
• •8. Patients will be excluded from this protocol if they are judged by the principal investigator as having a significant impairment in their capacity for judgment and reasoning that compromise their ability to make decisions in their best interest.
• •1\. Pre-existing or concurrent serious chronic medical or psychiatric illness.
• •1. Pre-existing or concurrent serious psychiatric or chronic medical illness besides Multiple Sclerosis.
• •2. Past history of significant head trauma, alcohol or substance abuse in the past 5 years or other medical illness, besides Multiple Sclerosis, that might produce neurologic deficit (such as cerebrovascular disease).
• •3. Previously received total lymphoid irradiation (TLI) or cladribine.
• •4. Has used immunoactive medications (excluding beta-interferon) in the three months preceding the study.
• •5. In the three months prior to the study initiation, was given such investigational treatments as plasmapheresis, hyperbaric oxygen, gangliosides, Copolymer 1, etc.
• •ELIGIBILITY OF SPECIAL POPULATIONS
• •Children: Children 13 years and older are eligible to participate in the PTLDS cohort because the condition under study can affect children. This age was selected as appropriate for the children to provide assent to and comply with the study procedures. Children younger than 13 will be excluded from the PTLDS cohort, and no children will be enrolled in the other study cohorts.
• •Pregnant and lactating women: Pregnant and lactating women are excluded from study participation. An enrolled participant who becomes pregnant during the study will be withdrawn
• •Adults who lack capacity to consent: Adults who lack decision-making capacity to provide informed consent are excluded at screening, and enrolled adult participants who permanently lose the ability to consent during study participation will be withdrawn
• •NIH staff members: NIH staff may be enrolled if they meet eligibility criteria. Neither participation nor refusal to participate as a subject in the research will have an effect, either beneficial or adverse, on the participant s employment or position at NIH. Every effort will be made to protect participant information, but such information may be available in medical records and may be available to authorized users outside of the study team in both an identifiable and unidentifiable manner.