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

NCT05033600 | Completed

• 1 other identifier: PTSD-Trauma-PEMF-PS2021
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Unspecified Trauma- and Stressor-Related Disorder

Keywords

PTSD; cPTSD; Anxiety; Insomnia; Self-Sabotage; Hyper-Sensitivity; Flashbacks; Irritability

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (1)

Interventional - PEMF Therapy Recipients

EXPERIMENTAL

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.

Interventions

S.C.I.O. DEVICE

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

Also known as: Scientific Consciousness Interface Operations Biofeedback Device, Nucleus Device, Eductor Device, Eductor1 Device

Interventional - PEMF Therapy Recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kasey Phifer: lead
• The National Centre for ElectroMagnetic Therapies CIC: collaborator

Study Sites (1)

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

Bristol, BS35 5RU, United Kingdom

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Kasey Phifer, B.A.

  The National Centre for ElectroMagnetic Therapies CIC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director & Lead Practitioner

Model Details: 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.

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: September 5, 2021
• Study Start: September 20, 2021
• Primary Completion: October 4, 2021
• Study Completion: October 4, 2021
• Last Updated: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data should be made available in October 2021 on the company website
• Access Criteria: No access criteria, publicly available

Locations

GB (1)