Current/Recent Research Studies

Current Studies In Progress

Research studies are listed below. If you think you may be interested and eligible based on the information below, please call us at 646-774-7503 and leave a message with your contact information. We appreciate your interest in research and hope to respond to you in a timely manner. In order to do so, we ask that you leave your email address in your message so that we may send you an initial screening. Thank you so much!


Reducing Chronic Pain in Post-Treatment Lyme Syndrome:

a Brain Imaging and Treatment Study

Background.  At least 5-15% of patients with Lyme disease (7,500-45,000 new cases a year) develop Post-treatment Lyme Syndrome (PTLS) - debilitating residual symptoms that last months to years, even after having received antibiotic treatment. Often patients with PTLS experience chronic pain in their muscles or joints or nerves.  

  • Do patients with PTLS benefit from treatment with a medicine that reduces central pain? Because many PTLS patients have pain that persists despite antibiotics and because we know that medicines which modulate the pain pathways in the brain can help to reduce or eliminate pain, we plan to treat patients with a medicine that is FDA approved for the treatment of pain.  This medicine is known as Milnacipran (the trade name is “Savella”); this medicine is not addictive and it has been shown to reduce chronic pain by its multiple actions on pain pathways. All patients in the study will be treated with this FDA approved medicine.


  • Second, we wish to test whether the pain can be improved even further by adding a medicine which is known to modulate the glutamate transmission involved with pain in the brain.  This medicine – D-Cycloserine – is actually an antibiotic, currently FDA approved for the treatment of tuberculosis.  Because of its action on glutamate receptors, we are hypothesizing that it will help to decrease pain even further in patients with Lyme-related pain.   In order to test this hypothesis, after 6 weeks of being on Milnacipran, all patients will then be given an additional treatment - either D-Cycloserine or a placebo pill (a placebo is a pill that does not contain any active medication.)  At the end of 12 weeks, we will then evaluate improvement compared to when the patient started in the study using the same clinical and neuroimaging (fMRI) tests.

Finally, we want to know whether patients with PTLS have over-active central pain circuits in the brain.   Because pain is processed through the brain’s pain circuits, we wish to examine whether people suffering from PTLS have hyper-active pain circuits that make them more sensitive to pain than those who have normally-active pain circuits.  To do this, we will be comparing patients with PTLS to healthy volunteers by conducting careful neurologic and brain imaging (fMRI) studies.   

We hope that this study will provide valuable information about how the brain processes pain signals in PTLS and about whether this treatment approach is effective. 

If you are between 18 and 55 years old, have been treated for Lyme disease, and have developed persistent pain post Lyme Infection, you may be eligible!

This study will take place at Columbia University Medical Center: 1051 Riverside Drive, New York, NY. Please email eb3048@cumc.columbia.edu for an initial screening or call us at 646-774-7503. If you are eligible, all study related procedures and treatment will be conducted at no financial cost to you.





A STUDY FOR PATIENTS WITH Newly Diagnosed Lyme Disease

Principal Investigator: Brian A. Fallon, MD

What are the Goals of this Research? This is a research study, and our long-term goal in this study is to reduce the number of patients who develop symptoms of chronic Lyme disease (also known as Post-treatment Lyme Syndrome) by identifying better tests and by understanding the immunologic, rheumatologic, and neurologic impact of this illness over time. This can only be done by comparing those patients who recover fully to those who experience ongoing symptoms

How will we do this? To do this, we need to bring patients with new onset Lyme disease into our Columbia Lyme Research Center in New York City as soon as possible after they get diagnosed with Lyme disease. Ideally, this would be within the first month or two after diagnosis. While at the Center, we will collect blood and conduct very careful clinical assessments.

How is this study helpful to the study participants? It is quite valuable to have objective measures of functioning and symptoms at the start of an illness. When the same tests are conducted months later, we can then determine whether the patient’s symptoms have resolved or whether there are residual or new problem areas. Because these assessments are done using well-standardized measures, useful information is gathered that can then guide physicians in deciding upon future treatment directions. We can provide to the study participant the results from some of the key measures of clinical status.

Am I compensated in any way for study participation? Yes, participants have the option of receiving a financial or tick-related gift for study participation.

Who is eligible to participate in this study? Individuals between the ages of 18- 89 who have been recently diagnosed with Lyme disease. Since this is a research study it is extremely important for us to determine eligibility of the participants. For this we will need all potential participants to have good documentation of Lyme disease with positive blood tests and well known clinical features (e.g., Lyme rash, meningitis, facial nerve palsy, arthritis, cardititis or heart block).

How do I learn more about research study participation?

Please email th2692@cumc.columbia.edu for an initial screening or call us at 646-774-7503.

*If you have a bullseye rash or recently had one within the past two weeks, please email Ellen Brown at eb3048@cumc.columbia.edu so that we may quickly direct you to next steps.

Status: Currently Enrolling




The CDC estimates that 10-20% of patients with Lyme disease will go on to have chronic symptoms despite having had appropriate treatment, a condition known as “Post-Treatment Lyme Disease Syndrome” (PTLDS). While there is currently no known cure, various therapies are being investigated. One promising approach is the practice of meditation and yoga which have been shown to help pain and fatigue associated with other chronic illnesses as well as to improve overall physical, mental, and emotional health.

We are exploring the efficacy of meditation and yoga in the management of fatigue and pain resulting from PTLDS.  Participants will be asked to attend Kundalini Yoga sessions for 8 weeks which will be led by a licensed physician who is also an instructor and has received extensive training in the art. Kundalini yoga is a centuries old form of yoga that emphasizes the control of breath and contemplation.

Currently, we are recruiting those who have developed pain and/or fatigue after getting Lyme disease that has persisted despite antibiotic treatment.

This study is taking place in the Fairfield, Connecticut area in the office of a physician with years of experience in these techniques. If you are not able to come to CT on a weekly basis for at least 8 weeks, then you would not be eligible for this study. As in all treatment studies, we ask patients to not change their other treatments during the course of this study. If you have any questions, please contact our research assistant Tarek Hijazi at 646-774-8100 or email th2692@cumc.columbia.edu or call 646-774-7503.

Status: Currently Enrolling


Recent Completed Studies

Laboratory Testing in Chronic Lyme Disease”

  • Principal Investigator:   Brian Fallon, MD
  • Goals: to determine whether Lyme Specialty Labs were better able to identify patients with CLD from non-Lyme controls and to determine which tests had the best sensitivity/specificity balance
  • Design:  Serum was drawn from the two groups of participants.  Serum from each patient was sent to 4 labs (1 University Based Lyme Lab, 2 Private labs with a Lyme Specialty, and 1 National Commercial Lab).  Samples were tests for ELISA, C6 ELISA, IgM Western blot, IgG Western blot.  When available, both the CDC and the lab’s own internal criteria were used for blot interpretation.
  • Funding:  Global Lyme Alliance, Inc.
  • Status: Study completed.
  • Read the following article about this study in Clinical Infectious Diseases:
  • Fallon BA, Petkova E, Coffino S, Brenner C.  A Comparison of Lyme Disease Serologic Test Results From 4 Laboratories in Patients With Persistent Symptoms After Antibiotic Treatment. Clin Infect Dis. 2014 Dec 15;59(12):1705-10 doi: 10.1093/cid/ciu703. Epub 2014 Sep 2. PMID:25182244

"Lyme Disease Community Blood Screening Study"

    • Principal Investigator: Brian Fallon, MD
    • Goals: To develop a national resource specimen bank for diagnostic test and biomarker development
    • Design: Patients will be screened in Lyme endemic areas and at the Columbia Lyme and Tick-Borne Diseases Research Center
    • Benefit: Patients will receive a copy of the Lyme C6 ELISA test result
    • Eligibility: Patients age 18-75 with clinical features of Lyme disease at all stages of illness
    • Funding: Lyme and Tick-Borne Diseases Research Center Gift Funds, Oxford Immunotec Ltd, Global Lyme Alliance, Inc
    • Status:  Study completed

“Proteomic Studies of CSF of patients with neurologic Lyme disease”

    • Principal Investigator: Steven Schuzter, MD, UMDNJ  
    • Goals: to identify novel proteins in CSF of Lyme patients
    • Design: the CSF of patients with chronic neurologic Lyme disease will be compared to the CSF of individuals without a known neurologic disease.  This study involves collaboration with several research groups.
    • Funding: Lyme Disease Association, Inc and Global Lyme Alliance, Inc
    • Status: study completed
    • How to learn more: read article "Distinct Cerebrospinal Fluid Proteomes Differentiate Post-Treatment Lyme Disease from Chronic Fatigue Syndrome" in PLoS ONE (Schutzer SE, Angel TE, Liu T, Schepmoes AA, Clauss TR, Adkins JN, Camp DG, Holland BK, Bergquist J, Coyle PK, Smith RD, Fallon BA, Natelson BH. Distinct Cerebrospinal Fluid Proteomes Differentiate Post-Treatment Lyme Disease from Chronic Fatigue Syndrome.  PLoS-ONE. 2011; 6(2): e17287. doi:10.1371/journal.pone.0017287)

“Brain SPECT Imaging in Chronic Lyme Disease”

    • Principal Investigator:  Brian Fallon, MD
    • Goals: to determine the clinical usefulness of Brain SPECT imaging when performed for clinical differential diagnosis in a patient with a history of Lyme disease.
    • Design: patients with a history of Lyme disease and volunteers without a history of Lyme disease had a brain SPECT.  Scans were read by experts in nuclear medicine blind to diagnosis.
    • Funding: Lyme Disease Association, Inc, and National Research Fund for Lyme and Tick-Borne Diseases.
    • Status:  Data collection completed.
    • How to learn more: 
    • Read: Fallon BA, Fallon BA, Keilp J, Prohovnik I, Van Heertum R, Mann JJ. Regional cerebral blood flow and cognitive deficits in chronic Lyme Disease. J Neuropsychiatry and Clinical Neurosciences, 2003; 15: 326-332
  • “Brain Imaging and Treatment of Persistent Lyme Encephalopathy”
    • Principal Investigator:  Brian Fallon, MD
    • Goals: to clarify the structural and metabolic abnormalities in the central nervous system of patients with chronic cognitive deficits and to evaluate the efficacy of 10 weeks of IV antibiotic therapy among these patients all of whom had received prior IV treatment
    • Funding: National Institutes of Health (National Institute of Neurological Disorders and Stroke)
    • Status: study completed. Additional papers in progress.
    • How to learn more:
    • See Featured Research (provide link)
    • Read the following articles from this study:
    • 1. Fallon BA, Keilp JG, Corbera KM et al: “A Randomized, Placebo-Controlled Trial of  Repeated IV Antibiotic Therapy for Lyme Encephalopathy.”  Neurology (2008; 70 (13); 992-1003)
    • 2. Keilp JG, Corbera KM, Slavov I et al: “WAIS-III and WMS-III performance in chronic Lyme disease J International Neuropsychological Society. 2006;12(1):119-129.
    • 3. Fallon BA, Lipkin RB, Corbera KM et al: “Regional Cerebral Blood Flow and Metabolic Rate in Persistent Lyme Encephalopathy. Arch Gen Psychiatry. 2009;66(5):554-563.
    • 4. Chandra AM, Keilp JG, Fallon BA.  Correlates of Perceived Health-Related Quality of Life in Post-treatment Lyme Encephalopathy.. Psychosomatics. 2013 Jul 9. doi:pii: S0033-3182(13)00078-9. 10.1016/j.psym.2013.04.003. [Epub ahead of print]
    • 5. Batheja S, Nields JA, Landa A, Fallon BA.  Post-treatment Lyme Syndrome and Central Sensitization. J Neuropsychiatry and Clinical Neurosciences, epub 2013 Feb 27. doi: 10.1176/appi.neuropsych.12090223
    • 6. Jacek E, Fallon BA, Chandra A, Crow MK, Wormser GP, Alaedini A. Increased IFNα activity and differential antibody response in patients with a history of Lyme disease and persistent cognitive deficits. J Neuroimmunol. 2013 Feb 15;255(1-2):85-91. Epub 2012 No
    • 7.Fallon BA, Petkova E, Keilp JG, Britton CB.  A Reappraisal of the U.S. Clinical Trials of  Post-Treatment Lyme Disease Syndrome.  Open Neurol J. 2012; 6:79-87. Epub 2012 Oct 5.

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