Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04577053
Status:
TERMINATED
Last Update Posted:
2022-04-13
First Post:
2020-09-17
Brief Title:
PEMF Therapy to Treat Lingering Symptoms of Lyme Disease After Treatment With Antibiotics
Sponsor:
Kasey Phifer
Organization:
The National Centre for ElectroMagnetic Therapies CIC
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
It was discovered during the study that Lyme Disease is a bio warfare weapon made in USA See Bitten by Kris Newby The second reason for stopping the study is lack of participant responses likely due to lack of payment for completing surveys
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEMF
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 andor wandering different location on different days Aching joints Headache Fatigue general tiredness loss of energy general exhaustion Mild recurrent fever andor chills occurring regularly Lack of oxygen in blood feelings of air hunger too high carbon dioxide levels in blood
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 andor wandering different location on different days Aching joints Headache Fatigue general tiredness loss of energy general exhaustion Mild recurrent fever andor 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 75 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 Worseningdecline or improvementreduction 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 mobilitymovement 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 4433 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 4433 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 4433 to 44-4449 an increase of approximately 0 0 Full recovery would be from 4433 to 100 an increase of 5567 100 Amount of improvement in the example is from 4433 to 81 an increase of 3667 It is then calculated 3667 5567 689
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 2667 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 2667 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 2667 to 265-27 an increase of approximately 0 0 Full recovery would be from 2667 to 100 an increase of 7333 100 Amount of improvement in the example is from 2667 to 81 an increase of 5433 It is then calculated 5433 7333 741
More information can be found published on the investigators website httpsbiofeedbackcentrebristolcouklyme-disease-clinical-trial
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 75 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 Worseningdecline or improvementreduction 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 mobilitymovement 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 4433 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 4433 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 4433 to 44-4449 an increase of approximately 0 0 Full recovery would be from 4433 to 100 an increase of 5567 100 Amount of improvement in the example is from 4433 to 81 an increase of 3667 It is then calculated 3667 5567 689
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 2667 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 2667 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 2667 to 265-27 an increase of approximately 0 0 Full recovery would be from 2667 to 100 an increase of 7333 100 Amount of improvement in the example is from 2667 to 81 an increase of 5433 It is then calculated 5433 7333 741
More information can be found published on the investigators website httpsbiofeedbackcentrebristolcouklyme-disease-clinical-trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Bioresonance Biofeedback | OTHER | Biofeedback Centre Bristol LTD | None |