A Study for Evaluating the SCIO Biofeedback Device's Ability to Increase Body Wellness After One 45-minute Session
Condition: Stress
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to determine if one 45-minute treatment with the SCIO
      (Scientific Consciousness Interface Operations System) biofeedback device would show a
      change, and hopefully an improvement, on a person's Body Wellness indicators (Quality of Life
      Questionnaire, Energy Index Factor, Strength, Oxidation, Flexibility, Memory, pH, and VARHOPE
      scores (V=voltage, A=amperage, R=resistance, H=hydration, O=oxygenation, P=proton pressure
      and E=electron pressure), electrical measures within the device. For subjects in the control
      group, it is expected that there will likely be an improvement of approximately 5% in
      measured variables. That is, subjects in the control group will likely report some of the
      positive changes listed above for test group subjects. However, on average, any positive
      change in post-treatment measures for control subjects is expected to occur to a
      significantly lesser degree than for subjects in the test group.
    

Detailed description: 
      The objective of the Study is to determine if one 45-minute treatment with the SCIO
      (Scientific Consciousness Interface Operations System) biofeedback device would show a
      change, and hopefully an improvement, on a person's Body Wellness indicators as defined by
      the following introductions to each hypothesis. There are three (3) hypotheses that are the
      objective of this study and they are defined below as Hypothesis#1, Hypothesis#2 and
      Hypothesis#3.

      Introduction#1: The body is an electrical process requiring volts and amps which conduct
      through resistance circuits to operate. All muscles are turned on by electrical impulse.
      Muscles themselves are magnetic using volts and amps for their operation. The brain is a
      massive collection of cells that have electrical activity that can be measured via the EEG
      (electroencephalography). The heart itself is the largest electro-magnetic engine and uses
      electrical impulses to influence the muscles of the heart to circulate blood. Most EEG
      (electroencephalography), ECG (electrocardiography) and EMG (electromyography) measures are
      only concerned with oscillatory properties and not so concerned with the volume or basic
      amperage of the circuit. The collective baseline of the circuit of EEG
      (electroencephalography), ECG (electrocardiography), EMG (electromyography) and GSR (galvanic
      skin response) measurements can give us a rating of the global body voltage, body amperage
      and skin resistance (V=voltage, A=amperage, and R=resistance respectively). There are norms
      of the V (voltage), A (amperage) and R (resistance) and certain people, due to stress or
      other factors, can have low V (voltage), A (amperage) and/or R (resistance).

      Hypothesis#1: Our hypothesis is that by measuring and calculating the Voltage, Amperage and
      Resistance, and then administering one 45-minute treatment with the SCIO (Scientific
      Consciousness Interface Operations System) for stress reduction and electro-stimulation
      biofeedback, the Voltage, Amperage and Resistance can be rectified. Our scale is from 0-110
      for the V, A and R measurements, so an improvement in these Body Wellness indicators is going
      towards the higher end of the scale.

      Introduction#2: The collective inductance and capacitance changes in the body are a
      reflection of redox potential and can reflect hydration (H) and oxygenation (O) indexes.

      Hypothesis#2: It is also the hypothesis of the study that these hydration (H) and oxygenation
      (O) indexes can be affected by one 45-minute treatment of stress reduction and the
      electro-stimulation biofeedback by the SCIO. Our scale is from 0-110 for the H and O
      measurements, so an improvement in these Body Wellness indicators is going towards the higher
      end of the scale.

      Introduction#3: Irregularities in EEG, EMG, ECG and GSR can be corrected through guided
      electro-stimulation. The V and A are also greatly affected by the charge stability of the
      free protons and electrons, (negative charges and positive charges in the body), which
      collectively make up the proton pressure (P) and electron pressure (E). The
      acidity-alkalinity balance is an electrical measure of the amount of positive versus negative
      charged particles. This can be measured by the carbon based electrodes of the SCIO through
      electro-stimulation biofeedback.

      Hypothesis#3: It is our hypothesis, that the proton pressure (P) and electron pressure (E)
      scores can be improved with one 45-minute treatment with the SCIO. The scale of normal P is
      75 and the scale for normal E is 65 and the scores show an improvement in these Body Wellness
      indicators is if they change towards this number.

      Together, these items of voltage (V), amperage (A), resistance (R), hydration (H),
      oxygenation (O), proton pressure (P) and electron pressure (E) form the term VARHOPE. These
      VARHOPE scores are essential for all body functioning, therefore our overall hypothesis is
      that within one 45 minute session, a measurable improvement in Body Wellness indicators can
      be achieved.
    

Intervention name(s): Universal Electrophysiological Biofeedback Treatment; Universal Electrophysiological Biofeedback Treatment
Intervention type(s): Device; Device
Intervention description(s): one 45 minute biofeedback treatment; one 45 minute placebo treatment
Other intervention name(s): SCIO biofeedback treatment; placebo treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Unfavorable effect of environmental factors, stressors