Clinical trial NCT01130454: A Study for Evaluating the SCIO Biofeedback Device's Ability to Increase Body Wellness After One 45-minute Session
Official title: A Double-blind Placebo-controlled Study of the Application of the SCIO Universal Electrophysiological Biofeedback System for Statistical Evaluation of the SCIO's Ability to Increase Body Wellness After One 45-minute Session
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stress
Keywords: Unfavorable effect of environmental factors, stressors
Lead sponsor: Maitreya Kft.
Sponsor class: INDUSTRY
First posted: 2010-05-26
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Individuals in this study will be humans who present with awareness of levels of perceived stress as well as injuries/pain as indicated by a response on the pre-test Wellness Questionnaire.
* Between 18 and 65 years of age.
* Male or female.

Exclusion Criteria:

* Extremely sick patients on more than 5 prescribed drugs
* Patients who are crippled, handicapped, or unable to move freely based on a licensed healthcare practitioner's statement
* Extremely healthy sports people or athletes with no symptoms or problems whatsoever
* Any known heart condition(s), such as cardiac arrhythmias, congestive heart failure disease, myocardial infarction
* Serious head trauma
* Pregnant, breast feeding, or planning pregnancy prior to the end of study participation
* Currently using a pacemaker
* Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in past two years
* Prior cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers
* Seizure disorder or family history of seizure disorder
* Infection or wound or any other external trauma in the areas to which the electrode bands of the SCIO device are to be attached
* Developmental disability or cognitive impairment that would make it difficult for the subject to partake in the clinical study, including adequate comprehension of the informed consent form and ability to record the necessary measurements
* Involvement in litigation and/or a worker's compensation claim and/or receiving disability benefits because of a stress-related or involved condition
* Participation in a clinical study or other type of research in the past 30 days

Primary outcomes:
measure: VARHOPE Score
timeFrame: average 3 months
Secondary outcomes:
measure: Energy Index Factor
timeFrame: average 3 months
measure: Strength Test
timeFrame: average 3 months
measure: Anaerobic Oxygenation Test
timeFrame: average 3 months
measure: Low Back Flexibility
timeFrame: average 3 months
measure: Side to Side Flexibility
timeFrame: average 3 months
measure: Neck Flexibility
timeFrame: average 3 months
measure: Memory Test
timeFrame: average 3 months
measure: pH Test
timeFrame: average 3 months
measure: Quality of Life Questionnaire
timeFrame: average 3 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Annex of Quantum Northwest Presents
state: Washington
city: Paris
country: France
facility: Annex of Hexagram SARL
city: Speyer
country: Germany
facility: CFI Centrum für Integrative Medizin
city: Timisoara
country: Romania
facility: Centrul de Biorezonanţă Dr. Băcean
state: Timis
Study officials:
name: Rainer Mutschler, MD
role: PRINCIPAL_INVESTIGATOR
References: