Lyme Disease Clinical Trial Volunteers: Study on New Test (Now Completed)
Lyme disease clinical trial volunteers play a critical role in advancing diagnostic research. This study, conducted by Dr. Daniel Cameron & Associates, focused on validating a newly developed Lyme disease test.
Note: This study is now complete. Thank you to all who participated.
Clinical research is essential to improving Lyme disease diagnosis.
Why Clinical Trials Matter in Lyme Disease
Dr. Daniel Cameron & Associates, located in the Hudson Valley region of New York, has long participated in clinical research focused on tick-borne diseases.
Since 1987, Dr. Cameron has evaluated and treated thousands of patients and has served as a clinical investigator in multiple research studies.
Advancing Lyme disease diagnosis depends on well-designed clinical trials with sufficient patient participation.
The Need for Larger Studies
Clinical research in Lyme disease has historically been limited by small sample sizes.
The National Institutes of Health (NIH) conducted four major trials over a decade, involving approximately 200 patients in total.
Given that an estimated 300,000 people are diagnosed with Lyme disease annually, this represents a relatively small evidence base for guiding treatment decisions.
This gap highlights the importance of expanding research participation and improving study design.
Focus of the Study
This project focused on validating a newly developed diagnostic test for Lyme disease.
Unlike treatment trials, this study aimed to improve detection—an area where current testing methods have known limitations.
Participants included individuals with newly diagnosed Lyme disease as well as those without prior infection.
Why This Research Still Matters
Although enrollment has closed, the need for improved Lyme disease diagnostics remains urgent.
Accurate testing is essential for early diagnosis, appropriate treatment, and better long-term outcomes.
Future studies will continue to rely on patient participation to advance understanding of Lyme disease.
Clinical Perspective
Research participation is a key part of improving care for patients with Lyme disease.
Expanding clinical trials and increasing patient enrollment will be essential to developing better diagnostic tools and treatment strategies.
Dr. Daniel Cameron, MD, MPH
Lyme disease clinician with over 30 years of experience and past president of ILADS.
Symptoms • Testing • Coinfections • Recovery • Pediatric • Prevention
Can I participate from 2.5 hours away?
We are working to improve laboratory tests in actual practice. You would have to come to the office. Unfortunately, it is not a treatment trial. Thanks for your interest.
Thank you Dr. Cameron for all you do in this battle. As a LD Advocate I would be interested in mentioning this to newly diagnosed Lyme sufferers and possibly passing the word. What is involved and what does the patient get out of it if anything and costs to participate.
It does not cost anything to participate. Participants would have to have their bloods drawn in the office. The study does not involve treatment. The study does help us understand how emerging tests work in actual practice.
How do I become part of this study?
Anna
Thanks for your interest. Call the office at 914 666 4665.
Terrific idea, Dr Cameron.
Will you be accepting any Canadians for this study?
We would accept Canadian’s into the study. Volunteers would have to be newly infected. We have to draw labs in the office.
Dr. is this only for NY state patients or any state/country that would come to see YOU?
Newly diagnosed means anyone at any stage, right? You could just have been diagnosed but have had it a long time.
I wonder if the diagnosis can be clinical or means prior testing has been done and is positive.
Hopefully this study does not require a positive test per CDC to enter.
Could you give specific answers on this blog of yours so ALL who read about this will know the answers? Big thanks!
Congrats for getting something going for the over 329,000 correctly diagnosed meeting cdc/idsa criteria!! 😉
bettyg, iowa lyme activist
46.5 yrs. chronic lyme
35 yrs. MISDIAGNOSED by 40-50 drs.
UNACCEPTABLE!
Thanks for your interest. We can draw blood from other states. The current study is limited to newly infected cases. The study does not required volunteers to meet a positive CDC Lyme disease test. The current studies does not include individuals who have been ill for a long time.
We need to do these initial studies to set up the groundwork for individuals ill for a long time.
Dr I was dx with Lyme 3-19-15
I’m still amazed at how no dr here in south Texas knows how to treat Lyme
they gave me 2 weeks of Doxy but wouldn’t give me anything for the swelling in my ankles I have seen 3 different Drs and none of them could really help me
I have had to wait 3 months to see a dr in Marble Falls Texas
my appointment is 9/29/15
Thank you for all you do to help in Lyme research
Thank you for your interest. Get well soon.
I was diagnosed 7/2013 may I still participate?
Sorry. We are only seeking volunteers who are newly infected this summer. Thanks for asking.
Is June 14 2014 newly diagnosed? That’s when the tick was embedded behind left ear?
Thanks for asking. We are looking for new cases or reinfections from this summer 2015.
Diagnosed in November, is 10 months diagnosed too long ago?
Had headaches all my life. I used to pull at least 10 ticks off my head every weekend in Old Lyme, CT. I took a lyme test in 1980 and it was non-reactive. Then the physician i had worked for said, “try the test again in 2000′. I tried it and came back as chronic lyme. I was treated with doxy and plaquenil. Still have head pain. Was diagnosed with pseudo tumor cerebri but my spinal tap pressure was normal. Fast forward 2016, I had a brain stroke and endarterectomy. Now it is 2019, and still have head pain. Tried every neurological drug under the sun, including Botox and Aimovig, but still no relief. I am still fighting for relief while doctors tell me just accept the pain.
It is so difficult to be sure a tick borne infection has resolved or to be sure that that you were not reinfected.