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SQUED™ Series 28.1 Home-use and Treatment of Autowave Reverberator of Autism (SQUED™)

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ClinicalTrials.gov Identifier: NCT03222375
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : November 28, 2017
Sponsor:
Collaborators:
Clinic of Synergetics, Department of Neurology/Neuropsychology WOMS
Institute of Medical Synergetics, Department of Cognitive Neurology WOMS
Laboratory of Neurocomputational Active Media WOMS
SQUED, Inc., USA
Center of Synergetics, Universität Stuttgart, Germany
Ivan Franko National University of Lviv, Ukraine
Danylo Halytsky Lviv National Medical University
World Organization of Medical Synergetics
World Autism Center, American Federation of Medical Synergetics
Information provided by (Responsible Party):
American Federation of Medical Synergetics

Study Description
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Brief Summary:

Locomotor, transport and information functions in human body systems are carried out by active media in autowave regimes! Any living organism is a (micro-macro-mega) hierarchy of autowave subsystems-an ensemble of loosely coupled subsystems of a simpler structure. From the highest levels of the hierarchy, Autowave Codes-Signals arrive, which determine the transitions of subsystems from one autowave regime to another Autowave interaction (of Complex Coherent Action). Autowave interaction is a process associated with the evolution and interaction of spatial and wave structures in the active media of the organism.

Chaos in organism functioning tells about health. Periodicity - Autowave reverberator may presage a disease - Autism Spectrum Disorder; Chaotic nature of oscillations in active media of physiological systems is more optimal for their vital functions than periodic one. Firstly, systems that function in chaotic regimes, can re-arrange themselves faster and easier in case of change of environmental conditions, i.e. the so called adaptive control is more easily implemented in them. Secondly, "spreading" of oscillations strength along comparatively wide frequency band takes place in chaotic regime.

When an organism is young and healthy, physiological systems show the elements of chaotic behavior, i.e. irregularity and chaotic dynamics are the extremely important characteristics of health. Decrease in changeability and appearance of stable periodicity of Autowave reverberator are often connected with Autism.

The main purpose is to study brain plasticity (the changes that occur in the brain through Autowave reverberator) in children with autism. Research suggests that during development, the brains of children may change in response to their Autowave reverberator differently than the brains of typically developing individuals. Investigators want to understand why and how this difference may contribute to the symptoms of autism spectrum disorder (ASD). In this study, the investigators will be examining the effects of non-invasive neuromodulation SQUED™ series 28.1 home-use for Treatment of Autowave reverberator of Autism.

Integrative Team World Organization of Medical Synergetics (WOMS) - collaborations between physicians and researchers with expertise in biostatistics, physics, mathematics, engineering, and computer science.


Condition or disease Intervention/treatment
Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders Asperger's Syndrome Neurobehavioral Manifestations Nervous System Diseases Device: SQUED™ series 28.1 home-use

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Study Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Home-Use of Semiconducting QUantum Excitonic Device: Image Converter/Sound Converter/Electromagnetic Converter to Improve Communicative Efforts, Speech, Language and Related Cognitive Functions in Children With Autism
Actual Study Start Date : September 26, 2017
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2027
Groups and Cohorts
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Group/Cohort Intervention/treatment
Autism
Individuals with autism will have either Image converter (iSQUED™) for Hysteresis of Spiral Autowaves, Sound converter (sSQUED™) for Drift of Spiral Autowaves or Electromagnetic converter (eSQUED™) for Annihilation Autowave reverberator.
 Device: SQUED™ series 28.1 home-use

Semiconducting QUantum Excitonic Device - artifificial active medium, where the processes of self-organization lead to creation and converter of Autowaves energy.

Some autowaves have the properties of quasi-particles!


Outcome Measures
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Primary Outcome Measures :
  1. SQUED™ software of patient [ Time Frame: Personal Autowave Diagnostics/Personal Autowave Therapy - through study completion, an average of 1 year ]
    This will be administered by Presence of Clinical protocol CRF-SQUED™and creation Active medium SQUED™ for a patient.


Eligibility Criteria
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Ages Eligible for Study:   1 Month to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be 1 month to 21 years of age, diagnosed with autism by independent clinicians and confirmed by formal assessment (e.g., CDI, ADOS, Bayley, Sensory Profile), and with receptive and expressive vocabulary levels of ≥ 3 years age-equivalent, as assessed by standardized measures. Additionally, the Autism Diagnostic Interview will be administered to caregivers in order to appropriately identify specific areas (regarding speech, language and cognition) in which participants are experiencing the most difficulty. The experimental group will consist of children (Infant, Child and Adolescent) with Autowave reverberators of Autism (n = 80): 1/2/3/4 armed/Left/Right_Spiral Autowaves.
Criteria

Inclusion Criteria:

  • Clinical diagnosis of autism or related conditions.

  • History of Late complications at Natal Trauma:

    1. Cerebral level of Natal Trauma - brain injury;
    2. Cervical level of Natal Trauma - injury of vertebral;
    3. Cerebral anoxia.
  • Identified language deficit(s) and/or other cognitive or behavioral impairments (which will be specific to each sub-study).

  • Adequate ability to perform the research tasks set for the Age level:

    1. Infant - greater than 1 month to 2 years of age;
    2. Child - greater than 2 to 12 years of age;
    3. Adolescent - greater than 12 through 21 years of age.

  • Presence on the Skin of the interruption of Autowave front (interruption of hair separatrix - dorsal/ventral) and/or of the Autowave Reverberators:

    1. Photo of Spiral Autowaves, generated by the kernel of Autowave Reverberator - the kernel having an excitation "tongue";
    2. Graphics on tracing paper of Spiral Autowaves, generated by the kernel of Autowave Reverberator - the kernel having an excitation "tongue".

  • Presence of Clinical protocol CRF-SQUED™:

    1. Diagnostics of Autowave reverberators and Nonlinear Control of Autowave reverberators in Active media (Autowave interaction of patient - Algorithmic approach);
    2. Mathematical Modeling of Autowave Reverberator and Computational Simulation of the treatment code (Trade Secret), and creation Active medium SQUED™ for a patient;
    3. Recording for a patient of treatment code (Trade Secret) - Autowave regime: Hysteresis of Spiral Autowaves; Drift of Spiral Autowaves; Annihilation of Autowave reverberator.
  • Magnetogram of region of Home-use and Geographic coordinates of Home-use.

Exclusion Criteria:

  • Peripheral blindness - precludes use of Image converter SQUED™ (iSQUED™).
  • Peripheral deafness - precludes use of Sound converter SQUED™ (sSQUED™).
  • Any implanted metal device - precludes use of Electromagnetic converter SQUED™ (eSQUED™).
  • Any implanted cardiac pacemaker - precludes use of Electromagnetic converter SQUED™ (eSQUED™).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03222375


Contacts
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Contact: Yuliya Yaroshuk, M.D.s. Ph.D. 502-338-0861 Dr.Yuliya.Yaroshuk@gmail.com
Contact: Yuriy Fihol, M.D.s. Ph.D. + 38 067-717-6873 Dr.Yuriy.Fihol@gmail.com

Locations
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United States, Kentucky
World Autism Center, American Federation of Medical Synergetics, Department of Neurology; Cognitive Neurology/Neuropsychology WOMS Recruiting
Louisville, Kentucky, United States, 40228
Contact: Yuliya Yaroshuk, M.D.s. Ph.D., Asso. Prof. M.S.    502-338-0861    Dr.Yuliya.Yaroshuk@gmail.com   
Sub-Investigator: Heorhiy A. Shynkarenko, Prof. Dr. Phys. Math. S.         
Sub-Investigator: Yuriy Fihol, M.D.s. Ph.D., Asso. Prof. M.S.         
Sub-Investigator: Volodymyr D. Vovk, Asso. Prof. Ca. Phys. Math. S.         
Ukraine
Clinic of Synergetics, Department of Neurology; Cognitive Neurology/Neuropsychology of the World Organization of Medical Synergetics Recruiting
Lviv, Solonka Village, Urozayna Street 41, Ukraine, 81131
Contact: Yuriy Fihol, M.D.s. Ph.D., Asso. Prof. M.S.    + 38 067-717-6873    Dr.Yuriy.Fihol@gmail.com   
Sub-Investigator: Volodymyr D. Vovk, Asso. Prof. Ca. Phys. Math. S.         
Sub-Investigator: Yuliya Yaroshuk, M.D.s. Ph.D., Asso. Prof. M.S.         
Sub-Investigator: Heorhiy A. Shynkarenko, Prof. Dr. Phys. Math. S.         
Sponsors and Collaborators
American Federation of Medical Synergetics
Clinic of Synergetics, Department of Neurology/Neuropsychology WOMS
Institute of Medical Synergetics, Department of Cognitive Neurology WOMS
Laboratory of Neurocomputational Active Media WOMS
SQUED, Inc., USA
Center of Synergetics, Universität Stuttgart, Germany
Ivan Franko National University of Lviv, Ukraine
Danylo Halytsky Lviv National Medical University
World Organization of Medical Synergetics
World Autism Center, American Federation of Medical Synergetics
Investigators
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Principal Investigator: Yuliya Yaroshuk, M.D.s. Ph.D. World Autism Center, American Federation of Medical Synergetics, Department of Neurology; Cognitive Neurology/Neuropsychology WOMS
Principal Investigator: Yuriy Fihol, M.D.s. Ph.D. Clinic of Synergetics, Department of Neurology; Cognitive Neurology/Neuropsychology of the World Organization of Medical Synergetics
More Information
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Additional Information:

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Responsible Party: American Federation of Medical Synergetics
ClinicalTrials.gov Identifier: NCT03222375    
Other Study ID Numbers: SQUED™ series 28.1 home-use
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: This will be administered by Presence of Clinical protocol CRF-SQUED™ and creation Active medium SQUED™ of Patient.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Personal Autowave Diagnostics/Personal Autowave Therapy
Access Criteria: SQUED™ software - Active medium SQUED™ of Patient

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by American Federation of Medical Synergetics:
Yaroshuk's MEGA-DISCOVERY · DIAGNOSTICS · TREATMENT
Yaroshuk's Scientific Medical School
Center of Synergetics
Controlling spatiotemporal chaos/Dr. Synergetic
Autowave processes in Medicine
Autowave Reverberator
Bifurcation of Dynamic systems on a plane
 Spiral Autowaves
Drift of Spiral Autowaves
Excitable medium and Cellular Automata
Stochastic Resonance and Coherence Resonance
Autowaves/SQUED
Theory of Semiconducting QUantum Excitonic Device
Additional relevant MeSH terms:
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Nervous System Diseases
Neurobehavioral Manifestations
Disease
Autistic Disorder
Autism Spectrum Disorder
Mental Disorders
 Neurodevelopmental Disorders
Asperger Syndrome
Developmental Disabilities
Child Development Disorders, Pervasive
Pathologic Processes
Neurologic Manifestations