Pulsed ElectroMagnetic Field (PEMF) Therapy in Treating Post-Traumatic Stress Disorder (PTSD) & Trauma
Primary Purpose
Unspecified Trauma- and Stressor-Related Disorder
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
S.C.I.O.
Sponsored by
About this trial
This is an interventional treatment trial for Unspecified Trauma- and Stressor-Related Disorder focused on measuring PTSD, cPTSD, Anxiety, Insomnia, Self-Sabotage, Hyper-Sensitivity, Flashbacks, Irritability
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.
Sites / Locations
- The National Centre for ElectroMagnetic Therapies CIC - Private Clinic at Hillside Studios, Berwick Lane, Easter Compton
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interventional - PEMF Therapy Recipients
Arm Description
90-minute sessions rendered twice weekly over three consecutive weeks. PEMFs are administered through electrodes attached to wrists, ankles and forehead of participant.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05033600
First Posted
July 20, 2021
Last Updated
October 19, 2021
Sponsor
Kasey Phifer
Collaborators
The National Centre for ElectroMagnetic Therapies CIC
1. Study Identification
Unique Protocol Identification Number
NCT05033600
Brief Title
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
October 4, 2021 (Actual)
Study Completion Date
October 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kasey Phifer
Collaborators
The National Centre for ElectroMagnetic Therapies CIC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unspecified Trauma- and Stressor-Related Disorder
Keywords
PTSD, cPTSD, Anxiety, Insomnia, Self-Sabotage, Hyper-Sensitivity, Flashbacks, Irritability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional - PEMF Therapy Recipients
Arm Type
Experimental
Arm Description
90-minute sessions rendered twice weekly over three consecutive weeks. PEMFs are administered through electrodes attached to wrists, ankles and forehead of participant.
Intervention Type
Device
Intervention Name(s)
S.C.I.O.
Other Intervention Name(s)
Scientific Consciousness Interface Operations Biofeedback Device, Nucleus Device, Eductor Device, Eductor1 Device
Intervention Description
The devices read, emit and entrain Electromagnetic waves of the body.
Primary Outcome Measure Information:
Title
Anxiety
Description
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.
Time Frame
3 weeks
Title
Hyper-Sensitivity
Description
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.
Time Frame
3 weeks
Title
Insomnia
Description
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.
Time Frame
3 weeks
Title
Self-Sabotage
Description
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.
Time Frame
3 weeks
Title
Reliance upon coping mechanisms such as drugs or alcohol
Description
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.
Time Frame
3 weeks
Title
Re-imagining or 3D flash backs
Description
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.
Time Frame
3 weeks
Title
Sudden outbursts of anger, mood swings, irritability
Description
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.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kasey Phifer, B.A.
Organizational Affiliation
The National Centre for ElectroMagnetic Therapies CIC
Official's Role
Study Director
Facility Information:
Facility Name
The National Centre for ElectroMagnetic Therapies CIC - Private Clinic at Hillside Studios, Berwick Lane, Easter Compton
City
Bristol
ZIP/Postal Code
BS35 5RU
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
anonymised data will be shared in raw format (spreadsheet .csv), analysed data will be disseminated first-hand and through peer-reviewed channels
IPD Sharing Time Frame
Data should be made available in October 2021 on the company website
IPD Sharing Access Criteria
No access criteria, publicly available
IPD Sharing URL
https://ncet.co.uk
Learn more about this trial
Pulsed ElectroMagnetic Field (PEMF) Therapy in Treating Post-Traumatic Stress Disorder (PTSD) & Trauma
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