Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000178549
Ethics application status
Approved
Date submitted
6/02/2024
Date registered
23/02/2024
Date last updated
24/03/2024
Date data sharing statement initially provided
23/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Electro-Magnetic-Frequency Therapy (EMF) for Chronic Fatigue
Scientific title
Effect of Electro-Magnetic-Frequency Therapy (EMF) on Circulating Rare Cell (CRC) count in chronic fatigue patients
Secondary ID [1] 311475 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic fatigue 332795 0
Viral Reactivation with Epstein-Barr Virus (EBV) 332952 0
Viral Reactivation with Cyto-Megalo-Virus (CMV) 332979 0
Viral Reactivation with Herpes Simplex Virus (HSV) 332980 0
Condition category
Condition code
Other 329518 329518 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Infection 329666 329666 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Electro-Magnetic-Frequency Therapy (EMF) consists of a suite of low frequency waves (<25x10^6 Hz) – lower than those emitted by mobile phones (1x10^8 Hz) – specific to the underlying infections / pathogens.
We will use the EMF device Spooky2 plus Phanotron plasma bulb or plasma tube, and a suite of frequencies specific to the patient's illness as per EMF/Rife catalogue ranging between 1 Hz and 3.5 MHz.
EMF therapy is adminstered by a EMF trained nurse, who will also monitor adherence to the therapy.
EMF waves are transmitted through the air whilst the patient is sitting closely (~10 cm-100cm) to the frequency emitting plasma tube. EMF sessions are typically of 60-90 min length, during which the patient can undertake some stationary relaxing activities, e.g. reading, writing, meditating, without using an electronic device.

A one-off EMF therapy session is scheduled initally, and treatment effectiveness assessed by 2x blood tests before and after the session.
The patient will then discuss with their health practitioner a treatment program of 12 week duration, e.g. twice weekly sessions for 12 weeks.
Intervention code [1] 327929 0
Treatment: Devices
Comparator / control treatment
Primary comparator: Patients are their own control. Treatment eff ectiveness will be assessed by Circulating Rare Cell (CRC) count by blood test before and after treatment.
Control group
Active

Outcomes
Primary outcome [1] 337314 0
Number of CRC/ml by cytology
Timepoint [1] 337314 0
Day 2, 3 months, 6 months post-commencement of treatment compared to baseline (Day1 before the treatment)
Secondary outcome [1] 431421 0
Symptom impact questionnaire
Timepoint [1] 431421 0
3 and 6 months post-commencement of treatment compared to baseline (before treatment Day 1)

Eligibility
Key inclusion criteria
adults with viral reactivated chronic fatigue
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with electronic implants, e.g. pacemaker, defi brillator, cochlear implant, ring-shaped metals in thebody
planning to introduce new treatments during the study period
unable to commit to regular treatment sessions over a 3 month period
unable to give consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
a. As this study has a pre-post design, patients will be their own control, and CRC counts on day 2, at 3 and 6 month will be compared to their baseline (before EMF treatment). As CRC count is reported in nCRC/ml, comparison will be simple subtraction, and changes in CRC count will be reported numerically and as percentage.

b. We will use the statistical program SPSS to analyse the change in Symptom Impact Scores at 3 and 6 months compared to baseline. Continuous data will be analysed using the t-test, and ANCOVA test, and categorical data will be analysed using the Chi-square and Kruskal-Wallis Test

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
1/12/2026
Actual
Date of last data collection
Anticipated
1/06/2027
Actual
Sample size
Target
25
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 42017 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 315761 0
Self funded/Unfunded
Name [1] 315761 0
Patient is self-funding
Country [1] 315761 0
Australia
Primary sponsor type
Individual
Name
AProf Dr Karin Ried
Address
Country
Australia
Secondary sponsor category [1] 317885 0
None
Name [1] 317885 0
Address [1] 317885 0
Country [1] 317885 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314622 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 314622 0
https://niim.com.au/research/niim-human-research-ethics-committee
Ethics committee country [1] 314622 0
Australia
Date submitted for ethics approval [1] 314622 0
15/01/2024
Approval date [1] 314622 0
29/02/2024
Ethics approval number [1] 314622 0
0135N_2024

Summary
Brief summary
The prevalence of chronic fatigue is high in Australia. There is a need for better understanding of underlying disease patho-physiology and reliable assessments of treatment effectiveness.

This intervention study aims to assess the treatment effect of Electromagnetic Frequency (EMF) therapy for patients with chronic fatigue using the viral reactivation test, a combination of the cytology-based Circulating Rare Cell (CRC) blood test, and viral marker testing for dormant viruses such as Epstein Barr Virus (EBV), Cyto-megalo-virus (CMV), or Herpes Simplex Virus (HSV).

Who is it for?
You may be eligible for this study, if you have chronic fatigue.

Study details
Patients will undergo an intial EMF session of 60-90 min to assess treatment effectiveness of the chosen patient-specific frequency program.
Effectiveness will be assessed by blood tests measuring the number of viral reactivated Circulating Rare Cells (CRC) before and 1 day after treatment.
If successful, the patient will discuss with their health practitioner a 12 week treatment plan, which may involved twice weekly EMF sessions for 12 weeks.
A follow-up CTC test at 3 and 6 months is scheduled to assess treatment effectiveness in the context of long-term clinical outcome.
It is hoped, that this study will provide insight into the effectiveness of EMF therapy for viral reactivated chronic fatigue, with the aim to reduce viral reactivation and improve symptoms and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132194 0
A/Prof Karin Ried
Address 132194 0
National Institute of Integrative Medicine, 21 Burwood Rd, Hawthorn VIC 3122
Country 132194 0
Australia
Phone 132194 0
+61399129545
Fax 132194 0
Email 132194 0
karinried@niim.com.au
Contact person for public queries
Name 132195 0
Karin Ried
Address 132195 0
National Institute of Integrative Medicine, 21 Burwood Rd, Hawthorn VIC 3122
Country 132195 0
Australia
Phone 132195 0
+61399129545
Fax 132195 0
Email 132195 0
karinried@niim.com.au
Contact person for scientific queries
Name 132196 0
Karin Ried
Address 132196 0
National Institute of Integrative Medicine, 21 Burwood Rd, Hawthorn VIC 3122
Country 132196 0
Australia
Phone 132196 0
+61399129545
Fax 132196 0
Email 132196 0
karinried@niim.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21965Ethical approval    387284-(Uploaded-01-03-2024-17-01-37)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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