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

NCT03222375 | Recruiting FDA Device

• 1 other identifier: SQUED™ series 28.1 home-use
• Study Type: observational
• Target: 80
• Locations: 2 countries
• Sites: 2

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.

Conditions

Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Asperger's Syndrome; Neurobehavioral Manifestations; Nervous System Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• SQUED™ software of patient

  This will be administered by Presence of Clinical protocol CRF-SQUED™and creation Active medium SQUED™ for a patient.

  Personal Autowave Diagnostics/Personal Autowave Therapy - through study completion, an average of 1 year

Study Arms (1)

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

Interventions

SQUED™ series 28.1 home-use DEVICE

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!

Autism

Eligibility Criteria

• Age: 1 Month - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Clinical diagnosis of autism or related conditions.
• History of Late complications at Natal Trauma:
• Cerebral level of Natal Trauma - brain injury;
• Cervical level of Natal Trauma - injury of vertebral;
• 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:
• Infant - greater than 1 month to 2 years of age;
• Child - greater than 2 to 12 years of age;
• 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:
• Photo of Spiral Autowaves, generated by the kernel of Autowave Reverberator - the kernel having an excitation "tongue";
• 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™:
• Diagnostics of Autowave reverberators and Nonlinear Control of Autowave reverberators in Active media (Autowave interaction of patient - Algorithmic approach);

You may not qualify if:

• 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™).

Sponsors & Collaborators

• American Federation of Medical Synergetics: lead
• Clinic of Synergetics, Department of Neurology/Neuropsychology WOMS: collaborator
• Institute of Medical Synergetics, Department of Cognitive Neurology WOMS: collaborator
• Laboratory of Neurocomputational Active Media WOMS: collaborator
• SQUED, Inc., USA: collaborator
• Center of Synergetics, Universität Stuttgart, Germany: collaborator
• Ivan Franko National University of Lviv, Ukraine: collaborator
• Danylo Halytsky Lviv National Medical University: collaborator
• World Organization of Medical Synergetics: collaborator
• World Autism Center, American Federation of Medical Synergetics: collaborator

Study Sites (2)

World Autism Center, American Federation of Medical Synergetics, Department of Neurology; Cognitive Neurology/Neuropsychology WOMS

Louisville, Kentucky, 40228, United States

RECRUITING

Clinic of Synergetics, Department of Neurology; Cognitive Neurology/Neuropsychology of the World Organization of Medical Synergetics

Lviv, Solonka Village, Urozayna Street 41, 81131, Ukraine

RECRUITING

Related Links

• Center of Synergetics, Universität Stuttgart, Germany
• Headquarters of World Organization of Medical Synergetics, Lviv - Solonka ( 49°45'56.6"N 23°59'53.7"E )
• Yaroshuk's Scientific Medical School
• Autowave processes in Medicine - book
• Nonlinear Control - book
• Drift of spiral wave in excitable media
• Some classic types of reverberator evolution - Hysteresis width
• Efficient control of spiral wave location in an excitable medium
• Autowave reverberator
• Modelling excitable media
• Excitable media
• Theory of bifurcations of dynamic systems on a plane - eBook "Mathematical on the Skin"

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Asperger Syndrome; Neurobehavioral Manifestations; Nervous System Diseases

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuliya Yaroshuk, M.D.s. Ph.D.

CONTACT

502-338-0861; Dr.Yuliya.Yaroshuk@gmail.com

Yuriy Fihol, M.D.s. Ph.D.

CONTACT

+ 38 067-717-6873; Dr.Yuriy.Fihol@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 19, 2017
• Study Start: September 26, 2017
• Primary Completion: September 1, 2022
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 28, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Personal Autowave Diagnostics/Personal Autowave Therapy
• Access Criteria: SQUED™ software - Active medium SQUED™ of Patient

Locations

UA (1); US (1)