NCT03222375 SQUED™ Series 28.1 Home-use and Treatment of Autowave Reverberator of Autism
| NCT ID | NCT03222375 |
| Status | Recruiting |
| Phase | — |
| Sponsor | American Federation of Medical Synergetics |
| Condition | Autistic Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2017-09-26 |
| Primary Completion | 2022-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2017-09-26 with a primary completion date of 2022-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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™).
Contact & Investigator
Yuliya Yaroshuk, M.D.s. Ph.D.
PRINCIPAL INVESTIGATOR
World Autism Center, American Federation of Medical Synergetics, Department of Neurology; Cognitive Neurology/Neuropsychology WOMS
Frequently Asked Questions
Who can join the NCT03222375 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 21 Years, studying Autistic Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03222375 currently recruiting?
Yes, NCT03222375 is actively recruiting participants. Contact the research team at Dr.Yuliya.Yaroshuk@gmail.com for enrollment information.
Where is the NCT03222375 trial being conducted?
This trial is being conducted at Louisville, United States, Lviv, Ukraine.
Who is sponsoring the NCT03222375 clinical trial?
NCT03222375 is sponsored by American Federation of Medical Synergetics. The principal investigator is Yuliya Yaroshuk, M.D.s. Ph.D. at World Autism Center, American Federation of Medical Synergetics, Department of Neurology; Cognitive Neurology/Neuropsychology WOMS. The trial plans to enroll 80 participants.