The CTN is led by senior investigators committed to improving the lives of individuals with Lyme and other tick-borne diseases.
The focus is treatment, as this is a major clinical need and a much neglected area. The CTN studies will help to shape medical
practice in the United States and elsewhere, as its study results will be published in prominent peer-reviewed journals.
This research however is not possible without the generous participation of the patient community. We thank all study participants
as they play such a vital role in this major public health endeavor!
Treatment research can be of different types. Some treatments are “open-label” meaning that the treatment is known by
participant and doctor. Some are “double-masked” meaning that neither participant nor doctor knows whether the participant
is receiving one treatment, another treatment, or an inactive drug (‘placebo’) or other intervention (‘masked’). Studies
generally vary in duration from 1-2 years. All studies are conducted under IRB-approved protocols and all participants are
carefully monitored for safety and clinical outcome. The public can learn more about current Lyme and other Tick-borne disease
treatment studies by going to www.clinicaltrials.gov. Just type in the name of
the tick-borne disease and you will find a list of current and completed studies.
Active Clinical Studies
The Clinical Trials Network has 7 studies for which patient recruitment is ongoing (see below). The studies are being led by investigators from
leading academic sites across the United States, including New York City (Mount Sinai Medical Center, Columbia University), upper New York State
(SUNY Upstate Medical in Syracuse), New Jersey (Hackensack Meridien Medical Center), Maryland (Johns Hopkins Univ), North Carolina (UNC at Chapel Hill),
and California (UC San Francisco). Participation in the studies is conducted at no charge to the patient. Each study has specific eligibility criteria,
so please click on the link to learn more. The majority of these studies focus on patients who have persistent or relapsing symptoms despite prior
antibiotic therapy for Lyme or other tick-borne diseases. These studies address critical unanswered questions. With our patient community as partners
in research, we can get answers to these critical question related to the treatment of Lyme and other tick-related diseases.
As new studies are approved and launched, we will post them here. Currently there are several supported studies at
different stages of development:
Tetracycline Treatment Tolerability
This clinical trial aims to assess preliminary data on the efficacy of 3 months of tetracycline treatment in reducing
persistent symptoms from Lyme disease.
(Location: Johns Hopkins University, Maryland)
Vagus Nerve Stimulation (taVNS) for Persistent Fatigue
This clinical trial investigates the safety, tolerability, and clinical benefit of at
home vagus nerve stimulation to reduce the burden of fatigue and other multisystem persistent symptoms triggered by Lyme disease.
(Location: Columbia University, New York)
Mast Cell Treatment in Post-Tick Bite Illness
This is a randomized controlled treatment study based on the hypothesis that the activation of mast
cells contributes to Post-treatment Lyme Disease Syndrome and similar post-tick bite illness.
(Location: UNC Hospital Chapel Hill, North Carolina )
Proteolytic Enzymes as Potential Treatments for Fibrin/Amyloid Deposition and Platelet Hyperactivation in Lyme Disease
This study aims to characterize fibrin/amyloid deposition and platelet hyperactivation in patients with persistent symptoms despite prior antibiotic therapy for Lyme disease.
In the treatment phase, this open label study will assess feasibility and tolerability of
lumbrokinase as a potential treatment.
(Location: Mount Sinai Medical Center, New York)
Pulse Dosed Ceftriaxone for Post-Treatment Lyme Disease
This study is based on laboratory research indicating that ceftriaxone may be more effective
against the Lyme organism when given every several days (pulse dosing) rather than daily. This study will assess tolerability, safety, and potential benefit
by comparing pulse dosing of ceftriaxone (every 5 days over a 6-week period) to pulse placebo among patients with persistent symptoms despite prior antibiotic
treatment for Lyme disease. The study is conducted at two sites: Hackensack Meridian in New Jersey
and SUNY Upstate in New York.
(Location: SUNY Upstate Medical Center, New York, and Hackensack University Medical Center, New Jersey)
Should you wish to learn about any of the other studies underway at the CTN nodes, please go to their specific webpage:
Additional related studies by our CTN investigators
Sana Health Clinical Trial
This study will investigate the effectiveness of the Sana Pain Reliever (Sana PR) at reducing chronic pain. The Sana PR is a device
that pulses light at a single wavelength but various frequencies. Through the earbuds, the device also plays different tones in
conjunction with the pulses. The trial will last a total of 14 weeks. 50 participants who have a diagnosis of Post-treatment Lyme
Disease and experience chronic pain are expected to take part in this study.
(Location: Mount Sinai Medical Center, New York)