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

PEMF Therapy to Treat Lingering Symptoms of Lyme Disease After Treatment With Antibiotics

Lyme Disease

Lyme Neuroborreliosis

Lyme Arthritis

Unknown Origin Fever

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/

Scientific Consciousness Interface Operations (SCIO) Class II FDA approved medical device

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

This is inversely describing fatigue, chronic fatigue and exhaustion which is a common symptom of Lyme Disease.

This will be described to participants in an easy-to-understand 'layman' terminology. Words here include e.g. muscle ache, soreness of muscles.

Stiffness, soreness and lack of range of motion in any and all joints

This is measuring the participant's own subjective feelings of mood and depression, not a clinical diagnosis.

mild, recurrent fever is a common symptom of Lyme Disease. Temperature will be measured by the participants themselves should they suffer from this.

CEO and Lead Practitioner

'Air Hunger' or the feeling of not getting enough oxygen when breathing

Inflammation of the brain and/or spinal cord measured using the scan built into the software to confirm whether any is present in absence of medical diagnosis. Patients will report on symptoms of encephalitis, i.e. confusion, seizures, difficulty speaking, sudden changes in behaviour

This is most likely due to hormone imbalance which results in depression, insomnia, confusion and other symptoms.

damage to the nerves resulting in loss of fine or gross motor skills, shooting pains along nerves

Pulsed ElectroMagnetic Field Therapy using square wave forms. In addition to set, pre-defined frequencies to aid the body's own immune system, the Artificial Intelligence incorporated into the software used will suggest a variety of frequencies to be administered during treatment. Due to the software's selection, these recommendations or selections from the software will likely be different in each treatment session.

Control group will not receive treatment.

PEMF Therapy to Treat Lingering Symptoms of Lyme Disease After Treatment With Antibiotics

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status