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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01130454
• Date of registration: 10/05/2010
• Prospective Registration: No
• Primary sponsor: Maitreya Kft.
• Public title: A Study for Evaluating the SCIO Biofeedback Device's Ability to Increase Body Wellness After One 45-minute Session
• Scientific 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
• Date of first enrolment: September 2009
• Target sample size: 151
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01130454
• 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
• Phase: Phase 2

Countries of recruitment

France, Germany, Romania, United States

Contacts

• Name: Rainer Mutschler, MD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Stress

Intervention(s)

Device: Universal Electrophysiological Biofeedback Treatment

Primary Outcome(s)

VARHOPE Score [Time Frame: average 3 months]

Secondary Outcome(s)

Anaerobic Oxygenation Test [Time Frame: average 3 months]

Energy Index Factor [Time Frame: average 3 months]

Memory Test [Time Frame: average 3 months]

Neck Flexibility [Time Frame: average 3 months]

Low Back Flexibility [Time Frame: average 3 months]

Strength Test [Time Frame: average 3 months]

Quality of Life Questionnaire [Time Frame: average 3 months]

Side to Side Flexibility [Time Frame: average 3 months]

pH Test [Time Frame: average 3 months]

Secondary ID(s)

CT-103-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors