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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Low-Voltage, Direct Current Pulsed ElectroMagnetic Field (PEMF) Therapy in Treating Patients With Post-Traumatic Stress Disorder (PTSD and cPTSD) and Trauma

Conditions
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Unspecified Trauma- and Stressor-Related Disorder

Intervention / Treatment
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* Device: S.C.I.O.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional - PEMF Therapy Recipients<br>90-minute sessions rendered twice weekly over three consecutive weeks. PEMFs are administered through electrodes attached to wrists, ankles and forehead of participant. | Device: S.C.I.O.<br>* The devices read, emit and entrain Electromagnetic waves of the body.<br>* Other names: Eductor1 Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | We will have a questionnaire for all patients. This will include ratings of their mood and feelings related to each of these symptoms. This questionnaire will be used in comparison to a similar questionnaire completed prior to the start date of the clinical trial. Rating systems such as 1 to 10 will be used, as well as an opportunity to write freely about their experiences during the trial. Statements will be used in which patients reply their own thoughts to them. | 3 weeks | 
| Hyper-Sensitivity | We will have a questionnaire for all patients. This will include ratings of their mood and feelings related to each of these symptoms. This questionnaire will be used in comparison to a similar questionnaire completed prior to the start date of the clinical trial. Rating systems such as 1 to 10 will be used, as well as an opportunity to write freely about their experiences during the trial. Statements will be used in which patients reply their own thoughts to them. | 3 weeks | 
| Insomnia | We will have a questionnaire for all patients. This will include ratings of their mood and feelings related to each of these symptoms. This questionnaire will be used in comparison to a similar questionnaire completed prior to the start date of the clinical trial. Rating systems such as 1 to 10 will be used, as well as an opportunity to write freely about their experiences during the trial. Statements will be used in which patients reply their own thoughts to them. | 3 weeks | 
| Self-Sabotage | We will have a questionnaire for all patients. This will include ratings of their mood and feelings related to each of these symptoms. This questionnaire will be used in comparison to a similar questionnaire completed prior to the start date of the clinical trial. Rating systems such as 1 to 10 will be used, as well as an opportunity to write freely about their experiences during the trial. Statements will be used in which patients reply their own thoughts to them. | 3 weeks | 
| Reliance upon coping mechanisms such as drugs or alcohol | We will have a questionnaire for all patients. This will include ratings of their mood and feelings related to each of these symptoms. This questionnaire will be used in comparison to a similar questionnaire completed prior to the start date of the clinical trial. Rating systems such as 1 to 10 will be used, as well as an opportunity to write freely about their experiences during the trial. Statements will be used in which patients reply their own thoughts to them. | 3 weeks | 
| Re-imagining or 3D flash backs | We will have a questionnaire for all patients. This will include ratings of their mood and feelings related to each of these symptoms. This questionnaire will be used in comparison to a similar questionnaire completed prior to the start date of the clinical trial. Rating systems such as 1 to 10 will be used, as well as an opportunity to write freely about their experiences during the trial. Statements will be used in which patients reply their own thoughts to them. | 3 weeks | 
| Sudden outbursts of anger, mood swings, irritability | We will have a questionnaire for all patients. This will include ratings of their mood and feelings related to each of these symptoms. This questionnaire will be used in comparison to a similar questionnaire completed prior to the start date of the clinical trial. Rating systems such as 1 to 10 will be used, as well as an opportunity to write freely about their experiences during the trial. Statements will be used in which patients reply their own thoughts to them. | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, PTSD, cPTSD, Anxiety, Self-Sabotage, Hyper-Sensitivity, Flashbacks, Irritability