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

NCT04577053 | Terminated DMC

• 2 other identifiers: PEMF-BRI-Lyme-Disease-2020Bioresonance Biofeedback
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Conditions

Lyme Disease; Lyme Neuroborreliosis; Lyme Arthritis; Unknown Origin Fever

Outcome Measures

Primary Outcomes (5)

• Overall Energy Levels

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

  18 months

• Myalgia

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

  18 months

• Joint stiffness

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

  18 months

• Depression

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

  18 months

• Fever/Chills

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

  18 months

Secondary Outcomes (4)

• Ability to Breathe

  18 months

• Encephalitis

  18 months

• Brain Fog

  18 months

• Nerve pain / damage

  18 months

Study Arms (2)

PEMF Therapy

EXPERIMENTAL

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.

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

Control

NO INTERVENTION

Control group will not receive treatment.

Interventions

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

Manufactured by QX World Ltd. in Budapest, Hungary

Also known as: INDIGO, QXCI, QUEX S, QUEX ED

PEMF Therapy

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kasey Phifer: lead

Study Sites (2)

The Bristol Centre for Biofeedback

Bristol, BS8 1LR, United Kingdom

Location

The National Centre for Electromagnetic Therapies CIC

Weston, BS24 9AY, United Kingdom

Location

Related Links

• Investigator website

MeSH Terms

Conditions

Lyme Disease; Lyme Neuroborreliosis; Fever of Unknown Origin

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Central Nervous System Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Fever; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The independant analyst will assess the results provided in the survey, which are collected by a third party (the Google Forms app) and therefore cannot be tampered with by the Investigator. Participants complete surveys on their own mobile devices or computers at home, without any possible supervision or influence by the Investigator. The Participants are each assigned a code with which they complete the surveys on-line. The codes do not imply hierarchy (e.g. 'Alpha'), do not include numbers so as not to prime participants' answers, and have been carefully selected to remain neutral from gender, nationality, ethnicity or religious references. Participants have been allocated randomly using a web-based random number generator. (Screenshots of results along with participants can be requested from the Investigator.)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: CEO and Lead Practitioner

Model Details: Control group and treatment group, no placebo

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: October 6, 2020
• Study Start: October 7, 2020
• Primary Completion: December 4, 2020
• Study Completion: September 28, 2021
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will remain permanently available. Only participant personal data is protected under GDPR and will need special written consent prior to sharing. Otherwise, all methodology, questions, protocol and forms are being made available online.
• Access Criteria: none, no login necessary. Contact the investigator if data protected under GDPR is desired, such as participants' dates of birth, names and nationalities (countries of birth)

Locations

GB (2)