Pulsed ElectroMagnetic Field (PEMF) Therapy in Treating Post-Traumatic Stress Disorder (PTSD) & Trauma

NCT ID: NCT05033600

Last Updated: 2021-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-20
• Study Completion Date: 2021-10-04

Brief Summary

Use of low-voltage, direct current pulsed electromagnetic fields (PEMF) in treating Post Traumatic Stress Disorder (PTSD), complex PTSD (cPTSD) and trauma-related injuries manifesting in physical and/or mental symptoms.

Detailed Description

The PEMF devices used are the Scientific Consciousness Interface Operations (SCIO) device; it is CE-marked, ISO certified and FDA classified as a Type II medical device. The device measures frequencies emitted by the patient as a Biofeedback tool, and then emits frequencies in square (50% duty cycle), sinus or sawtooth wave form.

Wave forms, frequencies (herz and kiloherz respectively), ampers and voltage are adjusted automatically using the in-built Artificial Intelligence of the software employed to control the SCIO machine. The maximum is 5 Direct Current volts.

Electrodes to both read and emit signals are placed on the forehead, wrists and ankles. Irregular frequencies are corrected by use of entrainment. Efficacy of entrainment is displayed in the software as a percentage between 0-100. A rectification level or entrainment result of 85-100% is considered successful treatment, that is, entrainment was as effective as possible for that one session.

PEMF therapy has already been shown to be effective in trauma, PTSD, anxiety and depression treatment. The University of Denmark have recently conducted a similar clinical trial, which investigated Transcranial Direct Current Electro-Magnetic Therapy for patients who were treatment-resistant to depression medication. This study was also a one-arm test. This test was conducted over the space of 8 weeks and involved 52 participants of mixed gender. All the results indicated a reduction in depression-related symptoms in different ways, using the Hamilton Depression Scale as a reference point. The baseline of the Hamilton Depression Scale dropped from 20.6 to 12.6, whilst 49 participants experienced a reduction of over 50% on the Hamilton Depression Scale. Their study concluded that Transcranial Electro-Magnetic Therapy was a beneficial treatment for treatment-resistant depression, and further studies should be conducted to highlight the potential benefits of similar treatments.

This pilot study does not make use of a placebo, no double-blind, and no control group. The aim of this pilot study is two-fold: Firstly to determine whether a lower total amount of sessions would be effective (namely twice weekly rather than five days a week over the course of three weeks); secondly, whether the setup and process of this pilot study can function at scale (multiple locations and relatively little training time required by therapists due to the artificial intelligence built into the software guiding the machine).

Conditions

Unspecified Trauma- and Stressor-Related Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional - PEMF Therapy Recipients

90-minute sessions rendered twice weekly over three consecutive weeks. PEMFs are administered through electrodes attached to wrists, ankles and forehead of participant.

Group Type: EXPERIMENTAL

S.C.I.O.

Intervention Type: DEVICE

The devices read, emit and entrain Electromagnetic waves of the body.

Interventions

S.C.I.O.

The devices read, emit and entrain Electromagnetic waves of the body.

Intervention Type: DEVICE

Other Intervention Names

Scientific Consciousness Interface Operations Biofeedback Device; Nucleus Device; Eductor Device; Eductor1 Device

Eligibility Criteria

Inclusion Criteria

• Human adults above or equal to 19 years of age
• All sexes and genders
• It is okay if they are currently seeking or undergoing complementary therapies and treatments for their PTSD such as cognitive behavioural therapy or anti-depressant pharmaceutical medications
• Diagnosed with PTSD and/or trauma
• Experiencing symptoms of PTSD and/or trauma, listed below:
• Re-imagining or 3D flash backs
• Sudden bouts of anger or irritability
• Self-sabotage
• Reliance upon coping mechanisms such as drugs or alcohol
• Insomnia
• Hyper-sensitivity
• Anxiety
• Able to travel to one of 3 treatment locations in London, Bristol or Bournemouth at the participant's own expense
• Able to attend all 6 treatments consisting of twice-weekly therapy sessions each 90 minutes in duration for three consecutive weeks

Exclusion Criteria

• Any person on medication for severe psychotic episodes and/or suicidal thoughts / attempts
• Anyone under the age of 18.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The National Centre for ElectroMagnetic Therapies CIC

OTHER

Sponsor Role: collaborator

Kasey Phifer

OTHER

Sponsor Role: lead

Responsible Party

Kasey Phifer

Director & Lead Practitioner

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kasey Phifer, B.A.

Role: STUDY_DIRECTOR

The National Centre for ElectroMagnetic Therapies CIC

Locations

The National Centre for ElectroMagnetic Therapies CIC - Private Clinic at Hillside Studios, Berwick Lane, Easter Compton

Bristol, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PTSD-Trauma-PEMF-PS2021

Identifier Type: -

Identifier Source: org_study_id