Clinical trial NCT05033600: Pulsed ElectroMagnetic Field (PEMF) Therapy in Treating Post-Traumatic Stress Disorder (PTSD) & Trauma
Official title: Low-Voltage, Direct Current Pulsed ElectroMagnetic Field (PEMF) Therapy in Treating Patients With Post-Traumatic Stress Disorder (PTSD and cPTSD) and Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unspecified Trauma- and Stressor-Related Disorder
Keywords: PTSD
cPTSD
Anxiety
Insomnia
Self-Sabotage
Hyper-Sensitivity
Flashbacks
Irritability
Lead sponsor: The National Centre for ElectroMagnetic Therapies CIC
Sponsor class: OTHER
Collaborators: name: The National Centre for ElectroMagnetic Therapies CIC
First posted: 2021-09-05
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This pilot study has one arm only: PEMF therapy treatment. This pilot study does not make use of a placebo, no double-blind, and no control group.
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Anxiety
timeFrame: 3 weeks
measure: Hyper-Sensitivity
timeFrame: 3 weeks
measure: Insomnia
timeFrame: 3 weeks
measure: Self-Sabotage
timeFrame: 3 weeks
measure: Reliance upon coping mechanisms such as drugs or alcohol
timeFrame: 3 weeks
measure: Re-imagining or 3D flash backs
timeFrame: 3 weeks
measure: Sudden outbursts of anger, mood swings, irritability
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: The National Centre for ElectroMagnetic Therapies CIC - Private Clinic at Hillside Studios, Berwick Lane, Easter Compton
Study officials:
affiliation: The National Centre for ElectroMagnetic Therapies CIC
name: Kasey Phifer, B.A.
role: STUDY_DIRECTOR
References: