A Study for Evaluating the SCIO Biofeedback Device's Ability to Increase Body Wellness After One 45-minute Session

This study has been completed.
Sponsor:
Information provided by:
Maitreya Kft.
ClinicalTrials.gov Identifier:
NCT01130454
First received: May 10, 2010
Last updated: November 24, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Stress
Device: Universal Electrophysiological Biofeedback Treatment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Maitreya Kft.:

Primary Outcome Measures:
  • VARHOPE Score [ Time Frame: average 3 months ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Energy Index Factor [ Time Frame: average 3 months ] [ Designated as safety issue: No ]

    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.

  • Strength Test [ Time Frame: average 3 months ] [ Designated as safety issue: No ]
    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.

  • Anaerobic Oxygenation Test [ Time Frame: average 3 months ] [ Designated as safety issue: No ]
    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.

  • Low Back Flexibility [ Time Frame: average 3 months ] [ Designated as safety issue: No ]
    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.

  • Side to Side Flexibility [ Time Frame: average 3 months ] [ Designated as safety issue: No ]
    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.

  • Neck Flexibility [ Time Frame: average 3 months ] [ Designated as safety issue: No ]
    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.

  • Memory Test [ Time Frame: average 3 months ] [ Designated as safety issue: No ]
    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.

  • pH Test [ Time Frame: average 3 months ] [ Designated as safety issue: No ]
    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.

  • Quality of Life Questionnaire [ Time Frame: average 3 months ] [ Designated as safety issue: No ]

    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.

    1. Rate your stress level.
    2. Rate how you feel in general.
    3. Do you have pain? Circle one: Yes/No. If yes, rate your pain.
    4. Do you have emotional trauma? Circle one: Yes/No. If yes, rate your trauma.
    5. Do you have an injury that causes discomfort? Circle one: Yes/No. If yes, rate your injury.
    6. Rate any symptoms you have that are of concern.


Enrollment: 151
Study Start Date: September 2009
Study Completion Date: April 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SCIO Test Group Device: Universal Electrophysiological Biofeedback Treatment
one 45 minute biofeedback treatment
Other Name: SCIO biofeedback treatment
Placebo Comparator: SCIO Placebo Group Device: Universal Electrophysiological Biofeedback Treatment
one 45 minute placebo treatment
Other Name: placebo treatment

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01130454

Locations
United States, Washington
Annex of Quantum Northwest Presents
Seattle, Washington, United States, 98102
France
Annex of Hexagram SARL
Paris, France
Germany
CFI Centrum für Integrative Medizin
Speyer, Germany, D-67346
Romania
Centrul de Biorezonanţă Dr. Băcean
Timisoara, Timis, Romania, 300458
Sponsors and Collaborators
Maitreya Kft.
Investigators
Principal Investigator: Rainer Mutschler, MD
  More Information

No publications provided

Responsible Party: Richard Lloyd Regulatory Manager, Maitreya Kft
ClinicalTrials.gov Identifier: NCT01130454     History of Changes
Other Study ID Numbers: CT-103-01
Study First Received: May 10, 2010
Last Updated: November 24, 2010
Health Authority: Germany: Ethics Commission
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Maitreya Kft.:
Unfavorable effect of environmental factors, stressors

ClinicalTrials.gov processed this record on July 24, 2014