StressPhase 2NCT01130454
A Study for Evaluating the SCIO Biofeedback Device's Ability to Increase Body Wellness After One 45-minute Session
A Phase 2 study testing Universal Electrophysiological Biofeedback Treatment in people with Stress, run by Maitreya Kft. at 4 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Universal Electrophysiological Biofeedback Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Sep 2009to Apr 2010
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
United States1 site
Annex of Quantum Northwest Presents
Seattle, Washington, 98102
Romania1 site
Centrul de Biorezonanţă Dr. Băcean
Timișoara, Timiș County, 300458
About this study
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
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.
Read the 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.
- Conditions
- Stress
- Being tested
- Universal Electrophysiological Biofeedback Treatment
- Keywords
- Unfavorable effect of environmental factors, stressors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal Electrophysiological Biofeedback TreatmentDevice
Also called SCIO biofeedback treatment
one 45 minute biofeedback treatment
Universal Electrophysiological Biofeedback TreatmentDevice
Also called placebo treatment
one 45 minute placebo treatment
| Study group | Role | What they receive |
|---|---|---|
| SCIO Test Group | Active comparator | Not described Receives: Device: Universal Electrophysiological Biofeedback Treatment |
| SCIO Placebo Group | Placebo comparator | Not described Receives: Device: Universal Electrophysiological Biofeedback Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
VARHOPE Score
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.
Measured: average 3 months
Secondary outcomes (9)
Energy Index Factor
Measurements taken: blood pressure and pulse left arm sitting.
The Energy Index Factor formula used:
Take the systolic left arm sitting + the diastolic left arm sitting x pulse = energy index factor.
- Below 9,000 indicates parasympathetic control.
- 14,000 indicate balance.
- 18,000+ indicate sympathetic neural control.
Measured: average 3 months
Strength Test
Patient holds the Dynamo-meter in one hand. They give one big squeeze with one hand on the Dynamo-meter and the investigator documents how many kilograms of strength the patient was able to exert. Done for both left and right hand.
Measured: average 3 months
Anaerobic Oxygenation Test
Patient starts in a seated position, relaxed and at a normal breath rate for 1 minute. The patient takes a deep breath at the same time that the investigator starts a stop-watch counting minutes, seconds and tenths-of-a-second. Patient stands up at a normal speed and sits down again at a normal speed while still holding breath as long as possible. As soon as patient stops holding breath and takes a new breath then investigator stops the stop-watch. Investigator must document the length of time that the patient held breath during Anaerobic Oxygenation Test.
Measured: average 3 months
Low Back Flexibility
Patient sits on the floor with legs stretched out in front, heels approximately 8 inches apart. The patient extends both hands, outstretched fingers towards their heels keeping legs straight. Patients are asked to do maximum stretch and touch the floor as far as they can, even going past the heels, if they can. The distance in inches from where their fingers touched the floor to the heels, with Zero at the heels, positive if they can extend past the heels, minus if they are before the heels. Normal scores are anywhere from -3 to 0, scores below -3 indicate low back difficulty.
Measured: average 3 months
Side to Side Flexibility
Patient stands on their knees without bending forward or backward at the waist, they lean to the left side and try to touch their left palm to the floor. Touch their knuckles to the floor or try to touch their fingers to the floor and we measure the extent of their flexibility. Normal readings are touching fingers or knuckles to floor. An advanced patient will be able to touch their palm. If they cannot touch their fingers it indicates a lack of flexibility. A protractor is used to determine the angle of flexibility.
Measured: average 3 months
Neck Flexibility
Patient tries to touch their ear to their shoulder without raising their shoulder to their ear. A protractor is used to determine the angle of flexibility.
Measured: average 3 months
Memory Test
A series of random digits is chosen. The suggested test method is to choose the first set of random numbers. If the patient remembers these numbers in the proper sequence (either forward or backward depending on the memory test), then the investigator adds 2 to the existing digit and adds one more digit to the end to increase the sequence by one digit. This method should be continued until the end. The investigator should always write down the digit to ensure that they can reference the actual list when the patient repeats the digits.
Measured: average 3 months
pH Test
An Over-The-Counter pH (acidity-alkalinity) Test Kit should be purchased and used for pre-test and post-test measurements. The pre-test reading should be taken within three (3) hours before the Treatment begins. The post-test may not be taken more than three (3) hours after the Treatment is completed.
Measured: average 3 months
Quality of Life Questionnaire
The investigator asks the patient the following questions. The Investigator explains that the rating is on a scale of 1-10, where 10 is more negative and 1 is more positive.
- Rate your stress level.
- Rate how you feel in general.
- Do you have pain? Circle one: Yes/No. If yes, rate your pain.
- Do you have emotional trauma? Circle one: Yes/No. If yes, rate your trauma.
- Do you have an injury that causes discomfort? Circle one: Yes/No. If yes, rate your injury.
- Rate any symptoms you have that are of concern.
Measured: average 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startSep 2009
- Primary completionNov 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maitreya Kft.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rainer Mutschler, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130454
- Sponsor's protocol ID
- CT-103-01
- Status last verified
- Nov 2010
- First submitted
- 10 May 2010
- Last updated
- 25 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01130454
- Acronym / sponsor ID
- CT-103-01
- Conditions
- Stress
- Keywords
- Unfavorable effect of environmental factors, stressors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Maitreya Kft.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 26 May 2010 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCIO Test Group | Active comparator | Device: Universal Electrophysiological Biofeedback Treatment |
| SCIO Placebo Group | Placebo comparator | Device: Universal Electrophysiological Biofeedback Treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| Universal Electrophysiological Biofeedback TreatmentAlso: SCIO biofeedback treatmentone 45 minute biofeedback treatment | Device | SCIO Test Group |
| Universal Electrophysiological Biofeedback TreatmentAlso: placebo treatmentone 45 minute placebo treatment | Device | SCIO Placebo Group |
Primary outcome
VARHOPE Score
Time frame: 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.
9 secondary outcomes
Energy Index Factor
Time frame: average 3 months
Strength Test
Time frame: average 3 months
Anaerobic Oxygenation Test
Time frame: average 3 months
Low Back Flexibility
Time frame: average 3 months
Side to Side Flexibility
Time frame: average 3 months
Neck Flexibility
Time frame: average 3 months
Memory Test
Time frame: average 3 months
pH Test
Time frame: average 3 months
Quality of Life Questionnaire
Time frame: average 3 months
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 25 Nov 2010.
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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.
Rainer Mutschler, MD principal investigator
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Universal Electrophysiological Biofeedback Treatment in people with Stress, run by Maitreya Kft. at 4 sites in 4 countries.
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 3 inclusion and 14 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 25 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, France, Germany, Romania. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
VARHOPE Score (time frame: average 3 months). 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 25 Nov 2010.