Our Double-Blind, Placebo-Controlled Study into the Efficacy of SCIO-Powered Automated Subspace Sessions to Treat PTSD

Frequently Asked Questions

Budget & Sponsors

Please visit our GoFundMe campaign page and make a donation by debit card or credit card.

If you would like to spare the payment processing fees or foreign currency conversion fees, we do accept payment in multiple currencies via bank transfer. Please include “PTSD Study” in the transfer reference memo.

In Pounds Sterling

Account holder: National Centre Electromagnetic Therapies CIC
Sort code: 23-14-70
Account number: 27685966
IBAN: GB04 TRWI 2314 7027 6859 66
Bank name: Wise

In Euros

Account holder: National Centre Electromagnetic Therapies CIC
BIC: TRWIBEB1XXX
IBAN: BE85 9673 0898 7806
Bank name: Wise

In US Dollars

Account holder: National Centre Electromagnetic Therapies CIC
ACH and Wire routing number: 084009519
Account number: 9600004374145184
Account type: Checking
Bank name: Wise

Please keep in mind that donations, also called contributions, do not qualify for Gift Aid in the UK. They are not a tax-deductible write-off in the USA. This is because our company is a not-for-profit, rather than a non-profit.

No, but we do have operational costs to cover. (See our Budget Outline on this webpage or on our GoFundMe campaign.)

We therefore ask anyone to contribute toward making this Clinical Trial take place, whether or not they are participating in the Study or know someone who is participating.

Yes, but our activities will be restricted to what our resources allow us to accomplish. Some cut-backs could take place, such as not publishing (also called “disseminating”) in peer-reviewed journals or not posting the Study on ClinicalTrials.gov.

Based upon our prior two Studies posted on ClinicalTrials.gov – which were also self-funded by our Centre, primarily one of our Directors – dissemination might not take place through the proper channels one might expect, such as in the British Medical Journal or other peer-reviewed mediums.

Participation Eligibility

Yes. We also require consent from you directly. That means, for example, we do not allow you to sign up your loved one for participation. We need to communicate directly with each participant.

Based upon our previous Pilot Study on PTSD, we have found that people who have already addressed their trauma in one way or another (for example, Cognitive Behavioural Therapy or talking therapy) had less hesitation in participating. We understand that it can be very scary to take the first step on the path toward healing. This is why we have a number of volunteers across three time zones to help answer any questions or concerns you have at a time that is convenient for you (such as after work in the evenings, or on weekends when the kids are away).

Those not allowed to participate in this PTSD Study:

  • Anyone under the age of 18 at the start of the Study
  • Anyone who has experienced trauma or PTSD less than one month before the Study begins
    If you are continuously experiencing trauma as part of your job, such as actively serving in the armed forces, working in emergency serivces, or working as a First Responder, you are able to participate in this Study.

If you are currently experiencing traumatic events that are not related to your normal job, please contact free and confidential services for immediate help:

UK — Help for Domestic Abuse: https://www.nationaldahelpline.org.uk — 0808 2000 247 (available 24 hours)

UK — Help for Substance Addiction: https://www.addiction.org.uk/contact-us — 0808 163 9632 (available 24 hours)

You will still be able to participate in this Study, even if you are taking other medications, drugs or therapeutic interventions.

Please inform us in the event that you are undergoing a psychological intervention such as CBT, and / or if you are taking pharmaceutical medications including ones that are not-yet-legal “self-medications” such as marijuana, MDMA or magic mushrooms. (The latter two are being researched in the UK and Europe currently as part of therapist-guided treatment for PTSD and Trauma.)

We would only need to account for these additional variables in the statistical analysis of the Study results. We do not report any substance use or substance abuse to the authorities. However, we do report any ongoing or recent cases of physical abuse, sexual abuse, self-harm and other life-threatening incidents of which we may be informed during the course of the Study. Our strict Ethics Policy always puts your health and safety first, whilst simultaneously respecting your right to privacy and freedom of choice.

Study Design

Yes.

A placebo group, also called a “sham group” or “sham therapy arm” is a portion of participants who do not receive therapy, but think that they are receiving therapy.

Our internal ethical review of this Study concluded that — in order to be fair to all persons participating, and to do our best effort in providing services to our community — we will offer the participants in the placebo group a chance to receive 12 weeks of the intervention therapy, free of charge or cost. We can only offer this after the Study is complete and the double-blind is lifted. (Please see the FAQ “Is the Study a double-blind one?” for more information.)

The original placebo group participants will not be asked to complete additional surveys, however, our team is ready and willing to provide continued support or guidance should you be one of the placebo group participants receiving after-Study therapy. (Please see the FAQ “Contact Information” for more details.)

Yes, this Study is a double-blind, also known as “twice masked”. That means neither the participants nor the contact partners coordinating the participants will know who has been assigned to which group.

In this Study, only one person on our team (of the three persons maintaining the servers and equipment) will be aware and keep record of the randomly assigned allocation of participants to either the placebo or the treatment group.

We cannot promise you will be in the treatment group.

We encourage you to seek therapy that will help immediately with any PTSD and trauma symptoms from which you are suffering. Please take any therapy or medications that your doctor or trusted healthcare professional recommends. We only ask that you inform us of any additional therapies, drugs or prescriptions that you might be taking or start taking during the course of this Study.

Electromagnetic frequencies can be ‘sent’ through wires or wirelessly. For highest accuracy, electromagnetic frequencies are sent through electrodes attached to the patient / participant’s body. However, based upon findings from our 2021 Pilot Study on PTSD, we have found that it is a considerable challenge for members of our community to sacrifice the time and money needed to come into clinic for treatment — even if that treatment is offered free of charge. This is why we are constantly innovating and developing ways to make our therapies more accessible, affordable and understandable. (For more information, please see our Vision and Mission Statements.)

Frequencies of a higher range do not need a medium through which to propagate or ‘travel’. That means, electrodes or other wiring are not necessary for the transmission of the electromagnetic waves, which we also call “frequencies”. For more information, please visit: https://science.nasa.gov/ems/02_anatomy

Contact Information

We cannot start recruiting participants more than three months before this Study is published on ClinicalTrials.gov. As we do not know when that will take place, we kindly ask you to submit your contact information if you are interested in participating. We will then contact you to submit an application for participation in the Study.

Please send us your contact information using this online form: https://forms.office.com/r/n6PCneWvUr

If you need assistance in completing the form, please email clinicaltrials@ncet.co.uk or ring us on +44 3301 3301 83 extension 102 or 103.

  • Dr Yvonne Van Veldhuizen, PhD MN BCHN
    clinicaltrials2@ncet.co.uk
    +44 3301 3301 83 ext. 103
  • Claudia E.
    clinicaltrials@ncet.co.uk
    +44 3301 3301 83 ext. 102
  • Linda L.
    LL@ncet.co.uk
    +44 3301 3301 83 ext. 101

Kasey Naví Phifer, Co-Director
admin@ncet.co.uk
+44 3301 3301 83 ext. 100

Please visit our GoFundMe campaign page and make a donation by debit card or credit card.

If you would like to spare the payment processing fees or foreign currency conversion fees, we do accept payment in multiple currencies via bank transfer. Please include “PTSD Study” in the transfer reference memo.

In Pounds Sterling

Account holder: National Centre Electromagnetic Therapies CIC
Sort code: 23-14-70
Account number: 27685966
IBAN: GB04 TRWI 2314 7027 6859 66
Bank name: Wise

In Euros

Account holder: National Centre Electromagnetic Therapies CIC
BIC: TRWIBEB1XXX
IBAN: BE85 9673 0898 7806
Bank name: Wise

In US Dollars

Account holder: National Centre Electromagnetic Therapies CIC
ACH and Wire routing number: 084009519
Account number: 9600004374145184
Account type: Checking
Bank name: Wise

Timeline

June 2023

  • Publish on GoFundMe, continue promotion for duration of study
  • Apply to ClinicalTrials.gov
  • Publish information online (website, social media, etc.)
  • Recruit participants — this might not happen immediately because we are not allowed to begin recruiting participants more than 3 months prior to the publishing of the study on ClinicalTrials.gov

July 2023

  • Continue all of the activities above

Aug 2023

  • Continue all of the activities above — unless already published on ClinicalTrials.gov, then the study can commence

Sep 2023

Estimated study begin date. Collect questionnaires.

Oct 2023

Collect questionnaires at the mid-treatment 45-day mark

Nov / Dec 2023

Collect questionnaires at the post-treatment 90-day mark

Jan, Feb, Mar, Apr 2024

  • Invite placebo group participants to try the 90-day treatment, free of charge, and no requirement to complete questionnaires
  • Statistical review and assessment
  • Dissemination

Meet the Team

Claudia
clinicaltrials@ncet.co.uk
+44 3301 3301 83 ext. 102

Volunteer to coordinate participants (answering questions, following up on incomplete assessment questionnaires). Location: Europe.

Yvonne van der Huizen
clinicaltrials2@ncet.co.uk
+44 3301 3301 83 ext. 103

Volunteer to coordinate participants (answering questions, following up on incomplete assessment questionnaires). Location: USA.

Linda LoCurto
clinicaltrials@ncet.co.uk
https://www.facebook.com/linda.locurto.7

Conducting primarily online services for promotion of fundraising, recruitment of participants, and wider dissemination. Location: Mexico and/or USA.

Bill Little
admin@ncet.co.uk

Server and device maintenance. Only team member knowing allocation of participants into sham or intervention group, because he is making the random allocation. Location: Canada.

Andrea Austin
admin@ncet.co.uk

Server and device maintenance. Location: Canada.

Peter Ugocean
admin@ncet.co.uk

Server and device maintenance. Location: Europe.

Cassandra Laticia Dominquez
admin@ncet.co.uk

Statistician to assess the outcome measures. Location: Mexico.

Kasey Naví Phifer
admin@ncet.co.uk
+44 3301 3301 83 ext. 100

Lead investigator and project manager. Location: USA and/or Europe.

PTSD Study Protocol

Long title: A Double-Blind, Placebo-Controlled Study into the Efficacy of Ultra Long-Range Frequency Devices for Treatment of Post-Traumatic Stress Disorder in Adults

Lead Investigator: The National Centre for ElectroMagnetic Therapies C.I.C., a not-for-profit serving the public interest registered in England & Wales under Companies House number 11486072

Lead Sponsor: to be determined – likely crowdfunding through GoFundMe

STUDY DESCRIPTION

Brief Summary:

The primary purpose of this study is to determine the efficacy of ultra long-range acoustic devices in alleviating or reducing symptoms of Post-Traumatic Stress Disorder (PTSD) in Adults.

A total of 40 participants will be randomly assigned to either the placebo (sham) group or the active (treatment) group in equal number using the double-blind method. Treatment consists of three separate sets of high-range frequencies emitted thrice daily over a period of 90 days.

Efficacy of treatment will be evaluated via questionnaires based on the DSM-5 PCL-5 to be completed by the participants.

Detailed Study Description:

PTSD and Trauma can be caused by a number of incidents such as serving in the armed forces, serving as a first responder in the emergency services, car accidents, domestic violence, rape, and physical abuse. It is estimated that 50-70% of the UK population will experience at least one traumatic event in their lives, and that 20% of those people will develop PTSD as a result; In the UK, that is more than 6.5 million people (Ref.: https://www.ptsduk.org/ptsd-stats).

Based upon a small pilot study conducted in 2021 and ensuing preliminary research not formally conducted, a certain level of efficacy in both in-harness and subspace treatments has been determined. “In-harness” describes electromagnetic treatment given through electrodes attached to the patient or participant’s body such as in tDCMS, PEMF or Neurofeedback. “Subspace” refers to ultra long-range electromagnetic treatment (from a distance of 100+ miles). Given the fact that electromagnetic waves (also referred to as “frequencies”) beyond a certain high range do not require a medium through which to propegate (Ref.: https://www.nasa.gov/directorates/heo/scan/spectrum/overview/index.html), the variables affecting efficacy of treatment which exist outside the control of the study yet within the boundaries of observation are the level of interference within the environment (i.e. radiation), the ability of the human body to act as a receptor of ultra high-range frequencies (i.e. due to dehydration or metal implants), the ability of the human body to respond physiologically (i.e. chemical balance of the brain manipulated by third-party substances such as SSRIs) and the ability of the human mind to process changes in the patterning of consciousness.

It is the latter variable, namely developed through non-somatic ‘talking therapy’ or Cognitive Behavioural Therapy (CBT), that has been proven most clinically effective when applied in combination with somatic or non-verbal therapy e.g. Trans-Cranial Direct Current Magnetic Stimulation (tDCMS), Pulsed ElectroMagnetic Field (PEMF) therapy, yoga (Ref.: NICE Guidelines 116 [D] Evidence reviews for psychological, psychosocial and other non-pharmacological). This is the reason for including even those participants who are currently taking pharmacological or other interventions as well as undergoing non-somatic / CBT / talking therapy during the 90-day period of this study.

One additional conclusion reached in the outcome of the Ethics Committee Review conducted internally by the Lead Investigator is — upon study completion — to notify those participants randomly assigned to the placebo group that they were in the placebo group and give them the option to receive the same intervention that the treatment group were given, free of charge and free from clinical evaluation. During the course of the study, the double-blind method will not be breached; Neither the participants nor the participant coordinators will be aware of which participant has been randomly assigned to which group.

Ultra Long-Range Frequency Treatment could be an extremely cost-effective, non-drug treatment for those suffering from PTSD and symptoms from overlapping conditions such as Insomnia, General Anxiety Disorder and Depression.

STUDY DESIGN

Study type: Interventional

Estimated enrolment: 40 participants

Allocation: Randomised

Intervention model: Parallel assignment

Masking: Double (participant, investigator)

Primary purpose: Treatment

Estimated study start date: September 2023 with staggered or rolling starts

Estimated primary completion date: January 2024

Estimated study completion date: April 2024

Arms: 2

(1) Intervention / treatment:

This group will receive thrice daily emissions of three separate sets of ultra long-range electromagnetic frequency treatment lasting 2 hours each in duration; The total hours of emissions amounts to 18 hours per day, per participant, for 90 consecutive days. The device used is ultra long-range electromagnetic generation, which can be performed with a number of machines sold on the public market by a number of manufacturers. The device used in this study is the Scientific Consciousness Interface Operations (S.C.I.O.).

(2) Sham: This group will not receive emissions.

Outcome measures:

Primary outcome measure: Change in PTSD Symptoms Measured by the Post Traumatic Stress Disorder Checklist (PCL-5) [Time Frame: Baseline to Post-treatment (90 days)]

PTSD symptoms are to be assessed with the PCL-5, a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD (Ref.: https://www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp). The PCL-5 has a variety of purposes, including: Monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. There will be no clinician-administered assessment.

a 17-item self-report measure of DSM-IV PTSD symptoms with strong psychometric properties (Wilkins, Lang, & Norman, 2011). Items are rated on how much the symptom bothered the respondent in the past month on a scale ranging from 1 (not at all) to 5 (extremely), with the sum score ranging from 17 to 85 providing a symptom severity rating, with higher ratings indicating more severe PTSD symptoms.

Secondary outcome measure: Change in the PTSD symtoms measured by the PCL-5 mid-treatment [Timeframe: Baseline to mid-treatment (45 days, allowing for data submission up to 48 hours before or after the 45-day mid-treatment mark)]

Secondary outcome measure: Self-reported change in quality of sleep measured by the Bergen Insomnia Scale post-treatment [Timeframe: Baseline to post-treatment (90 days)]

ELIGIBILITY CRITERIA

Age: 18 years and older

Sexes: All

Time elapsed since traumatic event or incident: 1 month and later

Inclusion Criteria:

Experienced or witnessed an extremely traumatic event that involved actual or threatened death, serious injury, sexual abuse or physical abuse to the participant.

The traumatic event or the first traumatic event must have occurred more than 1 month ago.

Must be experiencing significant symptoms of PTSD as measured on the PCL-5 with a score ≥ 35.

Have a telephone or computer with internet connection in order to complete the self-assessment questionnaires.

English is the primary language.

Exclusion Criteria:

Unable to give informed consent.

Unable to complete all three self-assessment questionnaires.

Budget (Costs and Hours)

In GBP

Server, hosting, SCIO useage: 150 per participant x 40 expected = 6,000

Project management (setup, providing information, questionnaires, training, posting information): 80 hours x 35/hr = 2,800

Volunteers for coordinating participants: 5 hours per participant x 0/hr = 0 (thank you!!)

Phone + email hosting: 60/month x 6 months = 360

Dissemination in ScientDirect.com (under category “contemporary clinical trials”): 2,320

Listing on ClinicalTrials.com: Free listing + 30 hours (preparation, study protocol, correspondence) x 35/hr = 1,050 **We aren’t sure whether this will pilot study will be accepted**

Statistical calculation, dissemination on our website or other free sources: 60 hours x 35/hr = 2,100

Subtotal = 14,630 + 2.3% transaction fees

TOTAL = 14.966.49 GBP