In recognition of a severe unmet need, the Steven & Alexandra Cohen Foundation’s grant to Columbia University established the first national Columbia Clinical Trials Network Coordinating Center (CTNCC) for Lyme and Other Tick-borne Diseases. Under the leadership of Dr. Brian Fallon, this Clinical Trials Coordinating Center aims to propel national research toward the goal of identifying more effective treatments for patients with Lyme and other tick-borne diseases.

Providing oversight to ensure that the highest-quality clinical trials are undertaken, the CTN Coordinating Center at Columbia will provide funding support for small pilot studies, assist investigators in protocol design and statistical research planning, establish and manage a national case registry, and create a data management system for multi-site clinical trials. The clinical trials network will be a powerful engine to drive large-scale clinical trials and potentially transformational early-stage research.

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Transforming Lyme Disease Research: New Classification System Introduced.

In a recently published article in “Frontiers in Medicine”, the Lyme and other Tick-borne Diseases Clinical Trials Network (LTD-CTN) proposed a new classification system that could transform Lyme disease research. Addressing the challenges of studying patients with persistent symptoms, this system proposes precise inclusion criteria for clinical trials in the field.

Developed in collaboration with clinicians, academic researchers, and patient advocates, the classification system defines Lyme disease cases across four levels of diagnostic certainty: well-defined, probable, possible, and uncertain. These categories provide clear guidelines for participant selection, ensuring that research is both rigorous and inclusive.

These criteria represent a significant step forward in helping researchers as they design studies to understand and address the sequelae of Lyme disease.

Spotlight on Lyme Disease in Pregnancy

Lyme disease, the most common vector-borne disease in the United States, is on the rise due to environmental and socioecological changes. This highlights the need to address potential adverse outcomes of Lyme disease exposure, particularly during pregnancy.

Untreated Lyme disease in pregnancy may lead to complications for both mother and child, yet long-term impacts on children exposed in utero remain under-researched. A recent review published by the CTN researchers in Pathogens explores Lyme disease as a congenital infection, examining its potential effects on infant and child neurodevelopment. It emphasizes the importance of distinguishing acute Lyme disease from Post-Treatment Lyme Disease Syndrome, as these conditions may affect fetal and child development differently.

The review highlights the importance of studying placental pathology in Lyme disease during pregnancy and calls for future research with clear case definitions and long-term follow-up of affected children. This work paves the way for deeper insights into protecting child neurodevelopment after antenatal Lyme disease exposure.

To learn more about the elements of clinical trials research that are of interest to patients, a survey was conducted in the fall of 2023. This survey aimed to provide insight into what types of studies prospective participants would be interested in. The findings from this survey would aim to inform future communications and strategies pertaining to patient recruitment for investigators conducting clinical trials on Lyme and other Tick-borne diseases.

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