New Government-Funded* Pilot Study “PEMF+” to Launch Q1 2021
A new year is almost upon us, and new projects are beginning to take shape. After much offline excitement, we’ve decided to break the news a bit early and share details in this post about the upcoming PEMF+ Pilot Study due to begin in the first quarter of 2021.
What is ‘PEMF Plus’?
PEMF stands for Pulsed ElectroMagnetic Field Therapy, and the little plus sign is a simple indicator that the programme is a bit more complex than the TENS machines running PEMF that we commonly know.
The programme will rely on the artificial intelligence built into the software interface for the machine used in the pilot study sessions. Essentially, it means that the practitioner will attach the electrodes, set the therapy focus (such as chronic pain or depression), set the time, and then let the programme do its thing. For a short demonstration of this and explanation of the pilot study, watch the video below.
(Video coming soon.)
Details of the PEMF+ Pilot Study
The core of this study is to test the viability of PEMF therapy at scale and at a low enough price to be affordable for those suffering from chronic illness and unable to work due to health reasons. Initial session will be offered at £70 for 90 minutes, and subsequent followup sessions offered at £50 for 60 minutes.
Therapy will be offered on a once-weekly or once-fortnightly basis. The total number of therapy sessions attended is completely up to the participants themselves. Focus of the therapy will be on these critical areas:
- Chronic Pain
- Detoxification after chemotherapy and/or radiation
Before the first session and upon completion of the last or final session identical surveys will be issued in order to measure the physical and emotional wellbeing of the therapy recipient in order to measure efficacy of the PEMF therapy rendered.
Location & Start Date
We plan to launch the PEMF+ pilot study in our private space in Weston Super Mare on Tuesdays in January. In February we should have the paperwork completed in time to launch the study in The Practice Rooms we hire hourly in Bristol Cotham Hill on Fridays. Further availability depends upon finding the right people to fit the roles – see below for open positions at the Centre beginning in 2021.
What is a Pilot Study?
The term was coined or invented by Kasey, the company Director. The term ‘pilot’ comes from the first of a television series, a sort of ‘first episode’ to test the waters and see whether the characters work well together and the audience wants more. ‘Study’ is obvious enough, but is important in this case to differentiate between a trial (which would be in a clinical setting) and a study (which is more about observation and measurement without making a claim to cure or use evidence to file for a patent, for example).
Why a Pilot Study?
After having completed the clinical aspect (that is, rendering treatment) of the Lyme Disease Clinical Trial, we’ve realised that although there are many positive advantages to doing clinical research and publishing via the usual, peer-reviewed routes, there are certain drawbacks:
- Due to strict patient privacy protection, we cannot be very transparent about the 360° experience – this means not being able to share our treatment protocols and real-life feedback with other certified practitioners, for example
- The process of peer review prior to dissemination takes a considerable amount of time
- Registering a clinical trial also takes a considerable amount of time, namely, in obtaining confirmation from the Research Ethics Committee that we are exempt from a committee review hearing.
Much like the Corona Virus vaccine being rolled out quickly for human uptake en masse, this pilot study ‘cuts corners’ in order to help people who desperately need it. It’s purely coincidence that the UK is the first country in the world to roll out vaccines and also the first place to hold a PEMF+ pilot study.
Is the PEMF+ pilot study safe?
Absolutely. Here are the three ways we’ve ‘cut corners’ to roll this out more quickly than ever before:
1. Bypassing paperwork for human trials
We’ve already conducted a clinical trial using the same medical device on humans. The technology remains the same: non-invasive, low voltage direct current with safe square wave forms. The Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K. states that ethics committee reviews are not needed in this scenario. Rather than repeat the paperwork we’ve completed for our recent clinical trial, we’ve decided to label this a ‘pilot study’ in the assurance that we don’t need to jump through legal hoops again so soon after we’ve just completed them simply for the sake of formality.
The device used – the S.C.I.O. is manufactured in Hungary – is CE marked, which means it’s safe for use whether for medical purposes or not. Furthermore it’s classified by the U.S. Food and Drug Administration as a Type II medical device. (The MHRA doesn’t have the ‘omnipotent’ requirements that the FDA do, so the S.C.I.O. device doesn’t need to be approved or regulated by the MHRA.) There are absolutely zero invasive procedures, not even blood or saliva or hair samples are needed.
2. Bypassing three years’ study prior to practice
The software itself requires considerable time to learn, memorise and navigate in addition to the usual A&P (anatomy and physiology), pathology and legal aspects that come with learning to practice electromagnetic therapies. The inventor of the device used in this pilot study, in yet another stroke of genius, decided to build a very simple-to-use form of the programme offering a handful of therapies that run on artificial intelligence. Although these programmes are limited in scope (see video above for details), practitioners in training can get started with only a few weeks’ training rather than 12+ months.
These simplified programmes do not require study of pathology. In order to also save time usually spent on learning A&P and honing bedside manner, we’re recruiting persons with prior professional experience such as registered nurses and midwives because they already possess the cross-border skills and abilities learnt during a Biofeedback apprenticeship or training.
3. More transparency
Similar to drug companies making announcements directly to the public prior to peer review of their COVID vaccine trials, we’re collecting data first-hand from pilot study participants and releasing these statistics in real time. PEMF therapy – and especially the machine we’re using in the pilot study – has consistently been proven to cause zero negative side effects in clinical trials conducted interationally over the past two decades. (It was invented and brought to market in 2002.)
By sharing this data in real-time – which is carefully anonymised prior to publishing – we can help other participants set realistic expectations for whether PEMF therapy will help their particular ailment and approximately how many sessions would be needed. We are particularily interested in reasons why PEMF therapy would not work, for example in cases of persons with extreme ElectroMagnetic Field (EMF) sensitivity or additional underlying conditions such as fibromyalgia along with allergies to gluten or IBS.
Is the pilot study funded by the UK Government?
Indirectly yes and only in part. Our Centre is not receiving funding explicitly for research purposes, and PEMF therapy for these purposes is not covered by NHS.
We’ve applied for the Kickstarter Programme which is a UK government initiative to tackle long-term unemployment. Youngsters aged 16-24 who are currently unemployed are matched up with businesses ready to create new roles for them, teach them skills, train them up and hopefully hire them on after the initial period working together. In brief:
- The UK government covers the paid internship at the national minimum wage
- The paid interns will work 25 hours per week, for 6 months
- Our Centre has applied for 2 interns to help with this pilot study, which is the largest reason why the price of sessions is so affordable
Kasey will be overseeing the interns personally throughout the pilot study, and in such a way that accomodates for the fast-paced schedule at the Centre. After greeting pilot study participants and starting the therapy, Kasey and the intern will step out of the therapy room to discuss feedback, respond to emails, aggregate surveys, et cetera. In this way, only half an hour is spent face-to-face with the participant rather than the full hour that the participant receives therapy.
What happens if the Kickstarter programme doesn’t come through?
If we are not awarded the two paid, part-time interns for some reason, or if we can find no suitable candidates for these newly created roles, the pilot study will continue. We have openings for both volunteer and paid, part-time positions and plan on releasing these job openings on the website and social media soon.
Interested in working with us?
Job descriptions and information will be published on our website and social media shortly for the following new roles:
- Content Marketing Intern – paid internship through Kickstarter, 25 hours/week, national minimum wage
- Research Assistant & Practitioner in Training – paid internship through Kickstarter, 25 hours/week, national minimum wage
- Practitioner in Training – part-time employment or zero-hours contract, flexible hours weekly, paid above national living wage
- Community Outreach Coordinator – part-time volunteer, able to receive free or reduced therapy at the Centre
Keep checking back for this information to be posted. If you have difficulty in applying for our new roles, contact us via social media or by ringing Kasey directly on 07394 870 156.