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

NCT01130454 | Completed Phase 2

• 1 other identifier: CT-103-01
• Study Type: interventional
• Target: 151
• Locations: 4 countries
• Sites: 4

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.

Conditions

Stress

Keywords

Unfavorable effect of environmental factors, stressors

Outcome Measures

Primary Outcomes (1)

• 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.

  average 3 months

Secondary Outcomes (9)

• 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

Study Arms (2)

SCIO Test Group

ACTIVE COMPARATOR

Device: Universal Electrophysiological Biofeedback Treatment

SCIO Placebo Group

PLACEBO COMPARATOR

Device: Universal Electrophysiological Biofeedback Treatment

Interventions

Universal Electrophysiological Biofeedback Treatment DEVICE

one 45 minute biofeedback treatment

Also known as: SCIO biofeedback treatment

SCIO Test Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maitreya Kft.: lead

Study Sites (4)

Annex of Quantum Northwest Presents

Seattle, Washington, 98102, United States

Location

Annex of Hexagram SARL

Paris, France

Location

CFI Centrum für Integrative Medizin

Speyer, D-67346, Germany

Location

Centrul de Biorezonanţă Dr. Băcean

Timișoara, Timiș County, 300458, Romania

Location

Study Officials

• Rainer Mutschler, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 26, 2010
• Study Start: September 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: April 1, 2010
• Last Updated: November 25, 2010

Record last verified: 2010-11

Locations

DE (1); FR (1); US (1); RO (1)