Clinical trial NCT04577053: PEMF Therapy to Treat Lingering Symptoms of Lyme Disease After Treatment With Antibiotics
Official title: Pulsed ElectroMagnetic Field Therapy With Square Wave Forms and Artificial Intelligence Within the Software Interface for Individualised, Bespoke Bio-Electromagnetic Therapy to Treat Symptoms of Chronic Lyme Disease Remaining After Antibiotics Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lyme Disease
Lyme Neuroborreliosis
Lyme Arthritis
Unknown Origin Fever
Lead sponsor: The National Centre for ElectroMagnetic Therapies CIC
Sponsor class: OTHER
First posted: 2020-10-06
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group and treatment group, no placebo
Primary purpose: TREATMENT

Brief summary: Overview

PEMF Therapy for relief or reduction of lingering symptoms after antibiotic treatment of Lyme disease of participants in the UK.

Symptoms monitored:

Muscle ache, myalgia, muscle pain that is acutely located and/or 'wandering' (different location on different days) Aching joints Headache Fatigue, general tiredness, loss of energy, general exhaustion Mild, recurrent fever and/or chills occurring regularly Lack of oxygen in blood, feelings of 'air hunger', too high carbon dioxide levels in blood

Detailed description: Hypothesis Period measured and observed: 18 months (Includes before treatment, during the 4-8 weeks of treatment and post treatment)

Control Group Control Group symptoms will remain the same or increase (deteriorate or worsen) by 10-20% over the period observed.

The Control Group is not asked to nor required to abstain from any other forms of treatment during the 10 month observational period; Persons in the Control Group are free to - but not encouraged to - pursue holistic, complementary and mainstream medicine for their symptoms related to contraction of Lyme Disease and any other illness that may arise.

In the event of receiving treatment or taking medicine, this information is to be passed along for data collection in the regular surveys. This will be taken into consideration when evaluating the results of the trial and hypothesis.

Test Group Test Group symptoms will improve (be reduced or eliminated) by 50-75% over the period observed; In particular, the largest improvement will be achieved during the 8 weeks of treatment. After treatment, there may be a slight improvement of symptoms, however, the improvement achieved during treatment is expected to remain the same over the next 7.5 months following treatment with the exception of re-infection or contraction of a different disease or illness.

The Test Group is not asked to nor required to abstain from any other forms of treatment during the 10 month observational period; Persons in the Control Group are free to - but not encouraged to - pursue holistic, complementary and mainstream medicine for their symptoms related to contraction of Lyme Disease and any other illness that may arise.

In the event of receiving treatment or taking medicine, this information is to be passed along for data collection in the regular surveys. This will be taken into consideration when evaluating the results of the trial and hypothesis.

Measurement (What the Investigator is Measuring and Observing in Response to Testing) and Weighting

Measurement: 1 to 100 Scale Worsening/decline or improvement/reduction of symptoms will be measured by the information collected in the surveys. Answers to questions are given subjectively by the participants themselves on a scale of 1 to 100, with 1 being the worst possible or imaginable and 100 being the best possible or imaginable. For example, the worst imaginable answer of "1" to the question of mobility/movement would be in the event that the participant is in a wheelchair or coma. Being confined to a wheelchair is certainly more mobile than lying in a comatose state, however, the answers to each question are subjective and so the participant might believe that a wheelchair would be the worst measure of mobility for him or her.

Weighting of Answers To weight the improvement or decline respectively for each participant, the average of the first three and last three surveys will be taken. This is to rule out any possible statistical outliers or anomalies due to the participant possibly having a 'bad day' or coincidental other illness such as a head cold.

Example Question:

Rate overall energy level on a scale of 1 to 100, where 1 is the lowest imaginable and 100 is the best, pre-Lyme Disease level possible.

Example Answers:

Participant A First survey: 45 Second survey: 40 Third survey: 48 25th survey (third to last): 80 26th survey (second to last): 83 27th survey (last or final): 80

Weighting here would be calculated in the following way:

Starting point or "zero point" is the average of the first three surveys

* ( 45 + 40 + 48 ) / 3 = 44.33 Ending point is the average of the last three surveys
* ( 80 + 83 + 80 ) / 3 = 81 An improvement of 100% for this participant would be from 44.33 at the starting point up to 100 at the ending point, what is to be considered a full recovery or full elimination of symptoms. The breadth of full recovery therefore contains a different amount of scala numbers for each participant, because a full recovery is based individually on each participant. This is to avoid an increase or decrease of more than 100%.

Using this example:

No improvement would be from 44.33 to \[44-44.49\], an increase of approximately 0 = 0% Full recovery would be from 44.33 to 100, an increase of 55.67 = 100% Amount of improvement in the example is from 44.33 to 81, an increase of 36.67; It is then calculated 36.67 / 55.67 = 68.9%

Participant B (Example Answers) First survey: 30 Second survey: 25 Third survey: 25 25th survey (third to last): 80 26th survey (second to last): 83 27th survey (last or final): 80

Weighting here would be calculated in the following way:

Starting point or "zero point" is the average of the first three surveys

* ( 30 + 25 + 25 ) / 3 = 26.67 Ending point is the average of the last three surveys
* ( 80 + 83 + 80 ) / 3 = 81 An improvement of 100% for this participant would be from 26.67 at the starting point up to 100 at the ending point, what is to be considered a full recovery or full elimination of symptoms.

Using this example:

No improvement would be from 26.67 to \[26.5-27\], an increase of approximately 0 = 0% Full recovery would be from 26.67 to 100, an increase of 73.33 = 100% Amount of improvement in the example is from 26.67 to 81, an increase of 54.33; It is then calculated 54.33 / 73.33 = 74.1%

More information can be found published on the investigator's website: https://biofeedbackcentrebristol.co.uk/lyme-disease-clinical-trial/

Eligibility criteria: Inclusion Criteria:

* Diagnosis from GP confirming Lyme disease and/or
* Blood test confirming Lyme disease and/or
* Symptoms that correlate to Lyme disease without diagnosis from GP. This is called "self diagnosis" and because 80% of the trial is focused on treating symptoms and not the spirochetes, bacteria or small cysts of Lyme disease, the results are expected to be largely the same

Exclusion Criteria:

* Persons currently undergoing antibiotic treatment for Lyme or other conditions
* Persons who were prescribed antibiotics but did not or could not take them

Primary outcomes:
measure: Overall Energy Levels
timeFrame: 18 months
measure: Myalgia
timeFrame: 18 months
measure: Joint stiffness
timeFrame: 18 months
measure: Depression
timeFrame: 18 months
measure: Fever/Chills
timeFrame: 18 months
Secondary outcomes:
measure: Ability to Breathe
timeFrame: 18 months
measure: Encephalitis
timeFrame: 18 months
measure: Brain Fog
timeFrame: 18 months
measure: Nerve pain / damage
timeFrame: 18 months
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: The Bristol Centre for Biofeedback
city: Weston
country: United Kingdom
facility: The National Centre for Electromagnetic Therapies CIC
Study officials:
References: