Unspecified Trauma- and Stressor-Related DisorderNCT05033600
Pulsed ElectroMagnetic Field (PEMF) Therapy in Treating Post-Traumatic Stress Disorder (PTSD) & Trauma
A study testing S.C.I.O. in people with Unspecified Trauma- and Stressor-Related Disorder, run by Kasey Phifer at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Unspecified Trauma- and Stressor-Related Disorder
- What is being tested?
- S.C.I.O.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Sep 2021to 4 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- Any person on medication for severe psychotic episodes and/or suicidal thoughts / attempts
- Anyone under the age of 18.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The National Centre for ElectroMagnetic Therapies CIC - Private Clinic at Hillside Studios, Berwick Lane, Easter Compton
Bristol, BS35 5RU
About this study
Official title: Low-Voltage, Direct Current Pulsed ElectroMagnetic Field (PEMF) Therapy in Treating Patients With Post-Traumatic Stress Disorder (PTSD and cPTSD) and Trauma
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.
Read the 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).
- Being tested
- S.C.I.O.
- Keywords
- PTSD, cPTSD, Anxiety, Insomnia, Self-Sabotage, Hyper-Sensitivity, Flashbacks, Irritability
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S.C.I.O.Device
Also called Scientific Consciousness Interface Operations Biofeedback Device, Nucleus Device, Eductor Device, Eductor1 Device
The devices read, emit and entrain Electromagnetic waves of the body.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: S.C.I.O. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start20 Sep 2021
- Primary completion4 Oct 2021
- Study completion4 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Trauma- and Stressor-Related DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasey Phifer
- Sponsor type
- University, hospital or other
- Collaborators
- The National Centre for ElectroMagnetic Therapies CIC
- Responsible party
- Sponsor-investigator, Kasey Phifer, The National Centre for ElectroMagnetic Therapies CIC
- Investigators
- Kasey Phifer, B.A., Study director, The National Centre for ElectroMagnetic Therapies CIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033600
- Sponsor's protocol ID
- PTSD-Trauma-PEMF-PS2021
- Status last verified
- Oct 2021
- First submitted
- 20 Jul 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: anonymised data will be shared in raw format (spreadsheet .csv), analysed data will be disseminated first-hand and through peer-reviewed channels
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Voltage, Direct Current Pulsed ElectroMagnetic Field (PEMF) Therapy in Treating Patients With Post-Traumatic Stress Disorder (PTSD and cPTSD) and Trauma
- ClinicalTrials.gov ID
- NCT05033600
- Acronym / sponsor ID
- PTSD-Trauma-PEMF-PS2021
- Keywords
- PTSD, cPTSD, Anxiety, Insomnia, Self-Sabotage, Hyper-Sensitivity, Flashbacks, Irritability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Kasey PhiferUniversity, hospital or other
- Collaborators
- The National Centre for ElectroMagnetic Therapies CIC
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 4 Oct 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Interventional - PEMF Therapy Recipients | Experimental | Device: S.C.I.O.90-minute sessions rendered twice weekly over three consecutive weeks. PEMFs are administered through electrodes attached to wrists, ankles and forehead of participant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (2 listed)
- Any person on medication for severe psychotic episodes and/or suicidal thoughts / attempts
- Anyone under the age of 18.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S.C.I.O.Also: Scientific Consciousness Interface Operations Biofeedback Device, Nucleus Device, Eductor Device, Eductor1 DeviceThe devices read, emit and entrain Electromagnetic waves of the body. | Device | Interventional - PEMF Therapy Recipients |
Primary outcome
Anxiety
Time frame: 3 weeks
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
Time frame: 3 weeks
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
Time frame: 3 weeks
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
Time frame: 3 weeks
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
Time frame: 3 weeks
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
Time frame: 3 weeks
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
Time frame: 3 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Individual participant dataSharing planned: Yes. anonymised data will be shared in raw format (spreadsheet .csv), analysed data will be disseminated first-hand and through peer-reviewed channels
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kasey Phifer, B.A. study director
The National Centre for ElectroMagnetic Therapies CIC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S.C.I.O. in people with Unspecified Trauma- and Stressor-Related Disorder, run by Kasey Phifer at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: 3 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.