Ignite Creation Date:
2024-05-06 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05033600
Status:
COMPLETED
Last Update Posted:
2021-10-20
First Post:
2021-07-20
Brief Title:
Pulsed ElectroMagnetic Field PEMF Therapy in Treating Post-Traumatic Stress Disorder PTSD Trauma
Sponsor:
Kasey Phifer
Organization:
The National Centre for ElectroMagnetic Therapies CIC
Study Overview
Official Title:
Low-Voltage Direct Current Pulsed ElectroMagnetic Field PEMF Therapy in Treating Patients With Post-Traumatic Stress Disorder PTSD and cPTSD and Trauma
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 206 to 126 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
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 206 to 126 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None