Clinical Investigation Plan summary
The Clinical Investigation Plan is to take pre-test measurements of Body Wellness indicators (VARHOPE scores, Quality of Life Questionnaire, Energy Index Factor, Strength, Oxidation, Flexibility, Memory and pH), then perform one 45-minute SCIO session following the approved protocol, and then take post-test measurements of the same Body Wellness indicators after the treatment. This data is then recorded on the Case Report Notes for analysis. The subject population is a random sampling of adults of any gender between the ages of 18 and 65 years of age. Nationality and ethnicity of the subjects is not a concern. The sample size should be minimum 120 subjects which would be 40 subjects from 3 sites. The Investigation End Point is set up to be when the minimum number of subjects has been reached or past and then statistical analysis will be performed on that data. This Clinical Study may be repeated again if needed or used as a foundation for future studies. There is no necessary follow-up as the protocol is not written to test the effects of the SCIO treatment over a certain period of time, but only within 3 hours of the treatment the post-test measurements need to be taken. The pass/fail criteria is that there is a significant number of subjects in the Test Group who have a significantly higher improvement in the Body Wellness Indicators in the post-test measurements compared to the pre-test measurements as compared to the Control Group. It is expected that, under the Placebo Effect, the Control Group will have an improvement of approximately 5%.
The objective of the Study was to determine if one 45-minute treatment with the SCIO 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. 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, ECG and EMG 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, ECG, EMG and GSR measurements can give us a rating of the global body voltage, body amperage and skin resistance (V, A, and R respectively). There are norms of the V, A and R and certain people, due to stress or other factors, can have low V, A and/or R.
Hypothesis#1: Our hypothesis is that by measuring and calculating the V, A and R, and then administering one 45-minute treatment with the SCIO for stress reduction and electro-stimulation biofeedback, the V, A and R 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.
The goal was to have 40 subjects for each testing site so that 50% were on a test device (meaning a device that fully functions) and 50% were on a placebo device (meaning a device that looks like it fully functions but does not offer any treatment). Where 40 subjects was not reached a number close enough to 40 was accepted with the goal of trying to get a 50/50 ratio test/placebo.
There were four (4) testing sites under this study with the following number of subjects:
i. Timisoara (Romania): 38
ii. Seattle, Washington (USA): 40
iii. Paris (France): 40
iv. Speyer (Germany): 33
Total number of subjects for this study is 151.
Subjects were recruited through local contacts on a voluntary basis for this one 45-minute treatment. Some were screened beforehand via phone or e-mail and others were screened upon arrival. Only a few subjects were excluded from participating in the study. Monitors, fully trained in the protocol, were in attendance to ensure proper adherence to the protocol, proper implementation of the recording methods, and proper documentation in the Case Report Notes. After the tests were completed at all 4 sites, Independent statisticians were hired to analyze the data and determine statistical significance. There were no Adverse Effects reporting during the study or in the weeks following the study to the date of this Final Report.
Investigation initiation & completion dates, including date of early termination, if applicable
The study was completed in four testing sites on the following dates. Timisoara, Romania from 2-4 September 2009, Seattle, Washington, from 23 – 25 October 2009, Paris, France from 17-20 November 2009 and Speyer, Germany from 23 – 27 November 2009. There was no early termination and therefore the study is complete.
The investigation was initiated on the 2nd of September 2009, in Timisoara, Romania, and completed on the 27th of November in Speyer, Germany. The total number of the subjects was 151. Out of the 151 patients that were eligible, 65 were randomly assigned to the Control Group, and 86 to the Treatment Group, as follows:
Control Group n=17
Treatment Group n=21
Seattle, Washington, U.S.A.
Control Group n=20
Treatment Group n=20
Control Group n=20
Treatment Group n=20
Control Group n=8
Treatment Group n=25.
The criteria for success was determined in the original, approved protocol as follows: “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.”
The results are as follows:
a. 86.90% of subjects had a V improvement of more than 5%,
b. 90.47% of subjects had an A improvement of more than 5%,
c. 88.09% of subjects had an R improvement of more than 5%,
d. 88.09% of subjects had an H improvement of more than 5%,
e. 89.28% of subjects had an O improvement of more than 5%,
f. 47.61% of subjects had a P improvement of more than 5%,
g. 48.80% of subjects had an E improvement of more than 5%.
Independent statisticians were contracted to review the data and it was determined that statistical significance is p < 0.005, meaning that the significance of this data above is acceptable.
Hypothesis#1 is therefore valid as shown by the high percentage of subjects who improved more than 5% in the V, A and R Body Wellness indicators (reference a., b. and c. above).
Hypothesis#2 is therefore valid as shown by the high percentage of subjects who improved more than 5% in the H and O Body Wellness Indicators (reference d. and e. above).
Hypothesis#3 is therefore valid as shown by the acceptable percentage of subjects who improved more than 5% in the P and E Body Wellness Indicators (reference f. and g. above).
Considering the statistical significance of the results of the VARHOPE Scores, all three (3) hypotheses are proven valid. Additionally, considering that there were no Adverse Events during or following the study, the safety results of the study show that the device’s performance and safety validate the study objective. The benefits far outweigh the potential for any risks as the subject’s body wellness improves with one 45-minute treatment with the SCIO. There are no other special precautions required for individual subjects
Authors and Date of Report.
Richard Lloyd, Regulatory Manager of Maitreya Kft. and Andreea Taflan, Monitor of the study were the main authors, while Dr Rainer Mutschler, Principal Investigator of the study was the co-author and grants approval of this Final Report.
The Head Investigator at each site is as follows and each signature is on the Cover Page of this Final Report. (Note: electronic signatures are acceptable until such time that one original goes around to all sites for original signatures). The original signed copy of the Final Report will be maintained with the Sponsor.
⦁ Timisoara, Romania: Codruta Bacean
⦁ Seattle, Washington: Gage Tarrant
⦁ Paris, France: Jacqueline Jacques
⦁ Speyer, Germany: Dr. Rainer Mutschler
The following standards and guidelines were referenced in the development, creation and implementation of the protocol as well as the follow-up to the study.
⦁ MEDDEV 2.7.1., April 2003, Guidelines on Medical Devices, Evaluation of Clinical Data: A Guide for Manufacturers and Notified bodies
⦁ NB-MED/2.7/Rec3, Evaluation of Clinical Data, 2.7. Clinical Investigation, Clinical Evaluation
⦁ Medical Devices Directive 93/42/EEC Annex X. 14 June 1993.
⦁ ICH Topic 6 Guidance for Industry Good Clinical Practice: Consolidated Guideline
⦁ ICH Topic 8 Guidance for Industry General Considerations for Clinical Trials
⦁ ICH Topic 9 Statistical Principles for Clinical Trials