A prospective study of patients with post treatment Lyme disease syndrome treated with modified VFEM energy

We previously demonstrated a possible therapeutic benefit of VFEM (variable frequency electromagnetic energy) technology for the treatment of Post Treatment Lyme Disease Syndrome (PTLDS) or Chronic Lyme Disease (CLD). As a result, we prospectively enrolled 10 patients, all having significant debility, to determine to what extent we could improve their quality of life. Eight patients completed the 10 treatments.


| BACKG ROU N D
Lyme disease is often a devastating illness, leaving many patients debilitated, unable to work, or maintain reasonable daily activities.
It can affect both physical and emotional states of well-being.Lyme patients often experience financial difficulties without the benefit of resolution of their symptoms with much of their treatment costs not covered by insurance.PTLDS and CLD are difficult to treat not only due to the ability of Borrelia to produce biofilm, but also having multiple morphologies thus resisting current treatments. 1 Another factor appears to be the slow replication rate of Borrelia, and its predilection for tissues not rich in blood supply which makes it more difficult for the immune system to respond to. 2 In the search for an affordable, dependable treatment for Lyme disease we are exploring the optimal therapeutic use of electromagnetic energy.][5][6][7][8][9][10][11][12] Earlier this year, we reported on five patients treated with high intensity electromagnetic energy for Post Treatment Lyme Disease Syndrome (PTLDS) or Chronic Lyme Disease (CLD). 13The number of treatments varied as well as the interval between treatments, ranging from days to months, due to patient location.All five patients had functional improvement after treatment.

| ME THOD
Ten female patients were enrolled prospectively, all having been diagnosed and treated by Lyme literate physicians.Each patient had undergone at least 3 years of treatment.The diagnostic basis for three patients was IGeneX PCR, and in two patients DNA ConneXions urinary antigen capture.In one patient, the IGeneX PCR was indeterminate with an MSIDS score of 87.In two cases, records of diagnosis were over 10 years old and unavailable.In the other two no records were available.The intent was to determine if 10 modified hertz rate treatments, with energies of at least 1.5 Tesla, over a 4-month period could ameliorate their symptoms, and if so, to what extent they could return to functionality and productivity.All patients were off other treatments and had various states of debility.Moreover, all antibiotics were discontinued for the duration of treatment.MSIDS scores were submitted by the patients prior to initiating treatment, regularly during treatment, and 2 weeks after completion of the 10 treatments.Midway through we added the GSQ-30 14 in addition to the MSIDS. 15Patients were allowed to review their pre-treatment MSIDS scores, and to the best of their ability, extrapolate this to a pre-treatment GSQ-30.All patients were female, ranging in age from 17 to 65 years of age.One patient withdrew from the study for personal reasons, and one patient had significant improvement, however, she did not discontinue antibiotics and is not included in the results.The remaining eight patients all had a good response to the 10 treatments.The interval between treatments varied for each patient, depending on the length and intensity of their Herx reaction.Each patient was allowed to recover for several days before initiating the next treatment.After the 10 treatments were concluded, we had each patient subjectively rate their improvement on a scale of 1-10, with 10 being the best overall status.

| Patient 1
A 53-year-old female who has suffered with Lyme disease for over 16 years, was previously treated with doxycycline, minocycline, clindamycin, and ultimately a PICC line with multiple IV antibiotics.These treatments were unsuccessful.More recently, she trialed Disulfiram with benefit but discontinued treatment, due to drug intolerance.Prior to her present debility, she had part time jobs catering and did charity work including baking goods for sales.Until she started treatment, it would take all day to execute a simple recipe for bread.She could only focus for a few minutes at a time, tired easily, and didn't have energy to perform daily household tasks or walk her dog.Now her cognitive function is near normal, she can perform her daily tasks normally, and take the dog for long walks without significant fatigue.She did not have a Herxheimer (Herx) reaction after the last treatment.VFEM treatment is by far the most successful treatment modality she has had.Her last Herx reaction lasted only 2 days including only mild fatigue.

| Patient 3
A 17-year-old female high school student diagnosed with Lyme disease at age

| Patient 4
A 22-year-old female part-time student suffering from untreated severe depression since 2012.In 2017 she developed headaches, fatigue, body pains, irritability, confusion, and difficulty thinking.She tested positive for Lyme disease and was treated with Disulfiram and nutritional therapy for 1 year without significant improvement.
According to her mother, the patient is concerned she will never have a normal life, although she has become more hopeful with the VFEM treatments.It is notable that both her MSIDS and GSQ-30 improved.
Her pre and post treatment scores are as follows:

| Patient 6
A 54-year-old female diagnosed with Lyme in 2006.Her debility reduced her ability to function at a desk job but was able to push through the day.She was not working when she entered the study.
Her symptoms included fatigue, pain, joint swelling, mild cognitive dysfunction, mood swings and depression.She is currently symptom free.This is the first time since she was 14 years old that "I don't feel elderly".
Her pre and post treatment scores are as follows:

| Patient 8
A 65-year-old female Realtor diagnosed 10 years ago with Lyme.
Treatments included oral antibiotics intermittently over 5 years, then again in 2017 for 1 year.In this cohort, all patients were female with ages ranging from 17 to 65.There was not an expectation that 10 treatments would result in resolution of symptoms, but rather we anticipated we could demonstrate significant improvement in the quality of life and return to productivity in all patients.This goal was achieved.

This modality has multiple advantages over current therapy. (1)
There are no known adverse side effects to the use of this regimen that has been FDA approved for cosmetic purposes.

| CON CLUS ION
All eight patients were pleased with the results, with all having a significant improvement in quality of life and productivity.We are currently in the process of refining various aspects of the treatment protocols, with regard to number of treatments, hertz rates, and energy levels.Ultimately, we hope to improve patient outcomes as well as reduce the time to return to a more normal life, while increasing the length of the disease-free interval.

CO N FLI C T O F I NTE R E S T S TATE M E NT
The study was self-funded with no conflict of interest.
Her pre and post treatment scores are as follows: post treatment subjective improvement score went from 3/10 to 7/10.Her first Herx reaction lasted 4 days consisting of fatigue, body aches, and brain fog.She did not have a Herx reaction after her last treatment.3.2 | Patient 2A 50-year-old mother with two children.She has been debilitated from Lyme disease for 3 years and has undergone treatment for over 1 year with Rifampin, Azithromycin, Nystatin, and nutritionals with only minimal improvement.Prior to treatment her primary complaints were lethargy and fatigue, requiring long naps after minimal activity.She also suffered from mood swings and depression as well as muscle aches and pains.Since treatment all her symptoms have improved significantly.Her pre and post treatment scores are as follows: MSIDS Pre Tx 50 GSQ-30 Pre x 48 Post Tx 30 Post Tx 37 Her pre and post treatment subjective improvement score went from 3/10 to 6/10.Her first Herx reaction lasted 5 days consisting of fatigue, hot flashes, dizziness, brain fog, and sleep disturbance.
post treatment subjective improvement score went from 3/10 to 7/10.Her first Herx reaction lasted 4 days consisting of fatigue, body aches, and brain fog.Her last Herx consisted of mild fatigue only for 2 days.

3. 5 | 5 A
Patient 51-year-old female Occupational Therapist on disability.She suffered from Lyme since 2009.In 2010 she was treated for 6 months with IV and oral antibiotics.In 2011, IV and oral antibiotics and in 2021 she was treated with oral antibiotics for 4 months without significant improvement.In 2022 she was treated with 6 months of Ceftin and Biaxin without benefit.Due to major muscle weakness, she at times needed a walker or a wheelchair to get around.After nine VFEM treatments she regained full functionality.She has trained in another career path but is now able to return to occupational therapy.Her pre and post treatment scores are as follows: Her pre and post treatment scores are as follows: post treatment subjective improvement score went from 4/10 to 8/10.Her first Herx reaction lasted 8 days consisting of brain fog, fatigue, joint pain, body aches, and stiffness.Her last Herx lasted 2 days consisting of only mild fatigue and mild aches.

3 . 7 | 7 A
post treatment subjective improvement score went from 3/10 to 9/10.Her first Herx reaction lasted only 1 day with severe muscle aches, headaches, and fatigue.She did not have a Herx reaction after her 9th or 10th treatment.Patient 62-year-old female interior designer with symptoms of Lyme for years but was not diagnosed until 2020.Initially she was treated with Azithromycin, Doxycycline, and Cefuroxime for 6 months with little benefit.In 2021 she traveled to Mexico for 2 weeks of intensive therapy including hyperthermia, antibiotics, ozone and other adjuvant therapy.In February 2022 she had a port inserted for IV Artesunate and IV Vitamin C. Her symptoms prior to high intensity electromagnetic energy treatment included fatigue, exertional dyspnea, joint and muscle pain, and cognitive dysfunction including short term memory dysfunction.After nine treatments she went hiking in the Cascade Mountains in Washington State.Her endurance and mental clarity had markedly improved.Her pre and post treatment scores are as follows: Her pre and post treatment scores are as follows: post treatment subjective improvement score went from 4/10 to 8/10.Her first Herx lasted 7 days in bed with vomiting, muscle soreness, brain fog, and weakness.She only had a mild Herx after her 10th treatment.

( 2 )
The gut microbiome remains unaltered unlike the negative effects with long term antibiotic therapy.(3) There is no need for follow-up laboratory testing.(4) These treatments consisted of 10-30-min treatments in an office setting without the need of IV's or other peripheral interventions.(5) Long-term durability appears to be superior to other modalities.(6) We believe we can markedly improve functional status cost effectively.At this point we anticipate being able to provide a full complement of treatments for approximately $5000.00.With maintenance treatments, when necessary, costing only several hundred dollars per year.