A Study for Evaluating the SCIO Biofeedback Device's Ability to Increase Body Wellness After One 45-minute Session
Completed · Phase 2 · Has a placebo group
Conditions studied: Stress
In brief
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.
Key facts
- Study ID
- NCT01130454
- Run by
- Maitreya Kft.
- People needed
- 151
- Starts
- 2009-09-01
- Expected to finish
- 2010-04-01
- Last updated by the study team
- 2010-11-25
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- Annex of Quantum Northwest Presents — Seattle, Washington, United States
- Annex of Hexagram SARL — Paris, France
- CFI Centrum für Integrative Medizin — Speyer, Germany
- Centrul de Biorezonanţă Dr. Băcean — Timișoara, Timiș County, Romania
Full record on ClinicalTrials.gov
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