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.
HOW AND WHEN TO APPLY FOR PILOT STUDY AWARD
We are happy to announce that the Clinical Trials Network established with a grant from the Steven & Alexandra Cohen Foundation to Columbia University
announces the third round of Pilot Study Proposal submissions (January 15 to April 15, 2023).
The Clinical Trials Network welcomes clinicians, researchers, and investigators from academic institutions to submit proposals. The proposals are typically
1-3 pages in length, but longer proposals are accepted for review. The CTN’s goal is to support the conduct of small-scale human treatment studies related
to treatment of Lyme and other tick-related diseases. These small pilot studies are conducted to determine whether future larger investigations are warranted.
Pilot studies often assess safety and feasibility, are exploratory in nature, and are not meant to answer the same questions as larger randomized control trials.
The Columbia CTN is happy to announce the following pilot study awards:
- Tetracycline treatment tolerability trial for PTLD
- Vagus nerve stimulation for persistent fatigue
- IV ketamine for depression in Lyme disease
- Transcranial direct current stimulation and cognitive retraining for Lyme brain fog
- Early neurodevelopmental outcomes of exposure to Lyme in pregnancy
- Mast cell treatment in post-tick bite illness (PTBI)
- Proteolytic enzymes as potential treatments for fibrin/amyloid deposition and platelet hyperactivation in Lyme Disease
- Pulse IV ceftriaxone therapy for patients with persistent symptoms in Lyme disease
To learn more about these studies, go to Active Clinical Studies
Thanks to everyone who participated in our 2021 request for suggestions on treatment for TBD!
We received 104 suggestions. The suggestions varied widely. Some contributors recommended more than one approach to treatment.
Your suggestions were not limited to treatment ideas: almost 30% described a diagnostic tool that could be used in TBD research.
Many suggestions described intriguing cases and patient histories. Treatment research ideas described antibiotics, non-pharmacological
types of treatment, and herbal treatment including diets and nutrition suggestions.
Your input is an invaluable way for our CTN Coordinating Center team to learn about novel treatment approaches that may improve
the care of individuals with Lyme and other tick-borne diseases.