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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 7
- 主要终点
- VARHOPE Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
VARHOPE Score
时间窗: average 3 months
VARHOPE is an acronym coined by the manufacturer in which V = Voltage, A = Amperage, R = Resistance, H = Hydration, O = Oxygenation, P = Protons and E = electrons. The VARHO readings are set on a scale from 0-110. Changes in the readings are shown on the scale where an increase in number shows in improvement. The PE readings are set on a scale where the closer the P reading to 75 the more the client's state of wellness has stabilized, and the closer the E reading to 65 the more the client's state of wellness has stabilized.
次要结局
- Energy Index Factor(average 3 months)
- Strength Test(average 3 months)
- Anaerobic Oxygenation Test(average 3 months)
- Low Back Flexibility(average 3 months)
- Side to Side Flexibility(average 3 months)
- Neck Flexibility(average 3 months)
- Memory Test(average 3 months)
- pH Test(average 3 months)
- Quality of Life Questionnaire(average 3 months)