Autistic DisorderSQUED™NCT03222375
SQUED™ Series 28.1 Home-use and Treatment of Autowave Reverberator of Autism
An observational study of Autistic Disorder and Autism Spectrum Disorder, run by American Federation of Medical Synergetics at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 21 years
- Conditions the study is for
- Autistic Disorder, Autism Spectrum Disorder, Child Development Disorders, Pervasive
- What is being tested?
- SQUED™ series 28.1 home-use
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 26 Sep 2017to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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).
Show all 18Show fewer
- 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);
- Mathematical Modeling of Autowave Reverberator and Computational Simulation of the treatment code (Trade Secret), and creation Active medium SQUED™ for a patient;
- 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.
Who cannot join
- 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™).
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
World Autism Center, American Federation of Medical Synergetics, Department of Neurology; Cognitive Neurology/Neuropsychology WOMS
Louisville, Kentucky, 40228
Yuliya Yaroshuk, M.D.s. Ph.D., Asso. Prof. M.S., 502-338-0861, Dr.Yuliya.Yaroshuk@gmail.com
Heorhiy A. Shynkarenko, Prof. Dr. Phys. Math. S.
Ukraine1 site, 1 recruiting
- Recruiting
Clinic of Synergetics, Department of Neurology; Cognitive Neurology/Neuropsychology of the World Organization of Medical Synergetics
Lviv, Solonka Village, Urozayna Street 41, 81131
Yuriy Fihol, M.D.s. Ph.D., Asso. Prof. M.S., + 38 067-717-6873, Dr.Yuriy.Fihol@gmail.com
Volodymyr D. Vovk, Asso. Prof. Ca. Phys. Math. S.
About this study
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
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.
Read more
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.
Read the detailed description
Autowave Reverberator:
- Proved that, a Autowave Reverberator appears a result of a rupture of Autowave front; initial conditions - Natal Trauma: 1.1 Proved that, such a rupture may occur, via collision of the Autowave front with a nonexcitable obstacle - brain injury or injury of vertebral; 1.2 Proved that, such a rupture may occur by loss of excitation in a certain region of the Active medium - cerebral anoxia; 1.3 Locomotor, Transport and Information functions in the physiological systems, and Communicative Efforts, Speech, Language and Related Cognitive Functions this is Autowave processes in Active media.
- An important feature of reverberators is that these Autowave sources have the highest frequency. By generating pulses at a maximum frequency such sources force out self-pacemakers of any other types from the medium. As a result, the Active medium is filled with only Spiral Autowaves: 2.1 The basic parameters of a reverberator are the frequency of generated waves, the critical dimension and characteristics of the structure of the kernel, and the velocity of the kernel in space, at Drift of Spiral Autowaves and/or Annihilation of Spiral Autowaves, or Multiplication of Spiral Autowaves; 2.2 Commonly, there are two characteristic regions in a reverberator: a kernel having an excitation "tongue" entering it and Spiral Autowaves generated by the kernel - one spiral/two spirals/three spirals/four spirals; central filament of the Autowaves-branch rotates Left/Right; 2.3 The kernel can have the form of a circle or a ring, a so-called "anomalous" kernel. If the source drifts, the form of the kernel is involved and can hardly be determined unambiguously.
- Proved that, the reverberator is not tied to any structure in the Active medium: 3.1 Proved that, due to this property, reverberators can Appear and Disappear in the different Endoderm/Mesoderm/Ectoderm of the Active media, and at different locations of the Active medium; 3.2 Proved that, due to this property, reverberators can Appear and Disappear in the Ectodermal Active media - Brain/spinal cord/hair/Skin; central filament of the endogenous Brain branch/exogenous Skin-branch; 3.3 Proved that, reverberators can Observe on the skin, Spiral Autowaves generated by the kernel - one spiral/two spirals/three spirals/four spirals; central filament of the Pileous-branch rotates Left/Right.
- Proved, Center of Synergetics/Dr. Synergetic (the name of a new physician - Nonlinear Control of Autowaves chaos in Active media), Nonlinear Control of Autowaves reverberators: 4.1 Proved, Nonlinear Control of Autowaves reverberators: Hysteresis of Spiral Autowaves, Drift of Spiral Autowaves and Annihilation of Spiral Autowaves.
- Treatment of Autowave Reverberator of Autism (this will be administered by Presence of Clinical protocol CRF-SQUED™):
5.1 Diagnostics of Autowave reverberators and Mathematical Modeling of Autowave reverberators in Active media + Algorithmic approach;
5.2 Computational Simulation of Autowave reverberator and Mathematical Modeling of treatment code (Trade Secret) + creation Active medium SQUED™ for a patient;
5.3 Recording for a patient of treatment code (Trade Secret) on the Image Converter/Sound Converter/Electromagnetic Converter + Autowave regime: Hysteresis of Spiral Autowaves; Drift of Spiral Autowaves; Annihilation of Autowave reverberator;
5.4 SQUED™ Treatment of Autowave reverberator of Autism (Novel type energy/Non-invasive) + Semiconducting Quantum Excitonic Device - artificial active medium, where the processes of self-organization lead to creation and converter of Autowaves energy.
Some autowaves have the properties of quasi-particles!
Participants in the study will be asked to do the following things:
- Grant permission for the researchers to view medical/psychological and/or educational and/or speech records associated with the diagnosis of autism.
- Complete a questionnaire and provide a health history.
- Complete evaluations by our study team to assess the diagnosis and gain a clearer understanding of the participant's current functioning.
- Give to our study team of Photo of Autowave Reverberator - Presence on the Skin of the interruption of Autowave front (interruption of hair separatrix - dorsal/ventral) and/or Photo of Spiral Autowaves, generated by the kernel of Autowave Reverberator - the kernel having an excitation "tongue".
- Give to our study team of Graphics on tracing paper of Autowave Reverberator - Presence on the Skin of the interruption of Autowave front (interruption of hair separatrix - dorsal/ventral) and/or Graphics on tracing paper of Spiral Autowaves, generated by the kernel of Autowave Reverberator - the kernel having an excitation "tongue".
- Complete several tasks and training interventions that involve such things as learning new words or pictures, saying words out loud, or naming objects.
- Complete several tasks and training interventions that involve such things as creation pictures iSQUED™ and music compositions sSQUED™.
- Give permission to audio and video-tape test sessions for later scoring and observation.
- Give permission to audio or video-tape in the Home environment or classroom using non-intrusive audio-visual recording devices.
- Participate in computerized tasks of Image converter SQUED™ (iSQUED™). The software/device poses no risk and is non-invasive.
- Participate in computerized tasks of Sound converter SQUED™ (sSQUED™). The software/device poses no risk and is non-invasive.
- Participate in computerized tasks of Electromagnetic converter SQUED™ (eSQUED™). The device/software poses no risk and is non-invasive.
- Conditions
- Autistic Disorder, Autism Spectrum Disorder, Child Development Disorders, Pervasive, Neurodevelopmental Disorders, Mental Disorders, Asperger's Syndrome
- Being tested
- SQUED™ series 28.1 home-use
- 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
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Child Development Disorders, Pervasive, Neurodevelopmental Disorders, Mental Disorders, Asperger Syndrome, Neurobehavioral Manifestations, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SQUED™ series 28.1 home-useDevice
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!
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SQUED™ series 28.1 home-use |
What is being measured
The primary outcome is the main question the study is designed to answer.
SQUED™ software of patient
This will be administered by Presence of Clinical protocol CRF-SQUED™and creation Active medium SQUED™ for a patient.
Measured: Personal Autowave Diagnostics/Personal Autowave Therapy - through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start26 Sep 2017
- Primary completionSep 2022 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Federation of Medical Synergetics
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Yuliya Yaroshuk, M.D.s. Ph.D., Principal investigator, World Autism Center, American Federation of Medical Synergetics, Department of Neurology; Cognitive Neurology/Neuropsychology WOMSYuriy Fihol, M.D.s. Ph.D., Principal investigator, Clinic of Synergetics, Department of Neurology; Cognitive Neurology/Neuropsychology of the World Organization of Medical Synergetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222375
- Sponsor's protocol ID
- SQUED™ series 28.1 home-use
- Acronym
- SQUED™
- Status last verified
- Nov 2017
- First submitted
- 13 Jul 2017
- Last updated
- 28 Nov 2017
- Results posted
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: This will be administered by Presence of Clinical protocol CRF-SQUED™ and creation Active medium SQUED™ of Patient.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03222375
- Acronym / sponsor ID
- SQUED™ / SQUED™ series 28.1 home-use
- Conditions
- Autistic Disorder, Autism Spectrum Disorder, Child Development Disorders, Pervasive, Neurodevelopmental Disorders, Mental Disorders, Asperger's Syndrome
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- American Federation of Medical SynergeticsUniversity, hospital or other
- 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
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Autowave Reverberator:
- Proved that, a Autowave Reverberator appears a result of a rupture of Autowave front; initial conditions - Natal Trauma: 1.1 Proved that, such a rupture may occur, via collision of the Autowave front with a nonexcitable obstacle - brain injury or injury of vertebral; 1.2 Proved that, such a rupture may occur by loss of excitation in a certain region of the Active medium - cerebral anoxia; 1.3 Locomotor, Transport and Information functions in the physiological systems, and Communicative Efforts, Speech, Language and Related Cognitive Functions this is Autowave processes in Active media.
- An important feature of reverberators is that these Autowave sources have the highest frequency. By generating pulses at a maximum frequency such sources force out self-pacemakers of any other types from the medium. As a result, the Active medium is filled with only Spiral Autowaves: 2.1 The basic parameters of a reverberator are the frequency of generated waves, the critical dimension and characteristics of the structure of the kernel, and the velocity of the kernel in space, at Drift of Spiral Autowaves and/or Annihilation of Spiral Autowaves, or Multiplication of Spiral Autowaves; 2.2 Commonly, there are two characteristic regions in a reverberator: a kernel having an excitation "tongue" entering it and Spiral Autowaves generated by the kernel - one spiral/two spirals/three spirals/four spirals; central filament of the Autowaves-branch rotates Left/Right; 2.3 The kernel can have the form of a circle or a ring, a so-called "anomalous" kernel. If the source drifts, the form of the kernel is involved and can hardly be determined unambiguously.
- Proved that, the reverberator is not tied to any structure in the Active medium: 3.1 Proved that, due to this property, reverberators can Appear and Disappear in the different Endoderm/Mesoderm/Ectoderm of the Active media, and at different locations of the Active medium; 3.2 Proved that, due to this property, reverberators can Appear and Disappear in the Ectodermal Active media - Brain/spinal cord/hair/Skin; central filament of the endogenous Brain branch/exogenous Skin-branch; 3.3 Proved that, reverberators can Observe on the skin, Spiral Autowaves generated by the kernel - one spiral/two spirals/three spirals/four spirals; central filament of the Pileous-branch rotates Left/Right.
- Proved, Center of Synergetics/Dr. Synergetic (the name of a new physician - Nonlinear Control of Autowaves chaos in Active media), Nonlinear Control of Autowaves reverberators: 4.1 Proved, Nonlinear Control of Autowaves reverberators: Hysteresis of Spiral Autowaves, Drift of Spiral Autowaves and Annihilation of Spiral Autowaves.
- Treatment of Autowave Reverberator of Autism (this will be administered by Presence of Clinical protocol CRF-SQUED™):
5.1 Diagnostics of Autowave reverberators and Mathematical Modeling of Autowave reverberators in Active media + Algorithmic approach;
5.2 Computational Simulation of Autowave reverberator and Mathematical Modeling of treatment code (Trade Secret) + creation Active medium SQUED™ for a patient;
5.3 Recording for a patient of treatment code (Trade Secret) on the Image Converter/Sound Converter/Electromagnetic Converter + Autowave regime: Hysteresis of Spiral Autowaves; Drift of Spiral Autowaves; Annihilation of Autowave reverberator;
5.4 SQUED™ Treatment of Autowave reverberator of Autism (Novel type energy/Non-invasive) + Semiconducting Quantum Excitonic Device - artificial active medium, where the processes of self-organization lead to creation and converter of Autowaves energy.
Some autowaves have the properties of quasi-particles!
Participants in the study will be asked to do the following things:
- Grant permission for the researchers to view medical/psychological and/or educational and/or speech records associated with the diagnosis of autism.
- Complete a questionnaire and provide a health history.
- Complete evaluations by our study team to assess the diagnosis and gain a clearer understanding of the participant's current functioning.
- Give to our study team of Photo of Autowave Reverberator - Presence on the Skin of the interruption of Autowave front (interruption of hair separatrix - dorsal/ventral) and/or Photo of Spiral Autowaves, generated by the kernel of Autowave Reverberator - the kernel having an excitation "tongue".
- Give to our study team of Graphics on tracing paper of Autowave Reverberator - Presence on the Skin of the interruption of Autowave front (interruption of hair separatrix - dorsal/ventral) and/or Graphics on tracing paper of Spiral Autowaves, generated by the kernel of Autowave Reverberator - the kernel having an excitation "tongue".
- Complete several tasks and training interventions that involve such things as learning new words or pictures, saying words out loud, or naming objects.
- Complete several tasks and training interventions that involve such things as creation pictures iSQUED™ and music compositions sSQUED™.
- Give permission to audio and video-tape test sessions for later scoring and observation.
- Give permission to audio or video-tape in the Home environment or classroom using non-intrusive audio-visual recording devices.
- Participate in computerized tasks of Image converter SQUED™ (iSQUED™). The software/device poses no risk and is non-invasive.
- Participate in computerized tasks of Sound converter SQUED™ (sSQUED™). The software/device poses no risk and is non-invasive.
- Participate in computerized tasks of Electromagnetic converter SQUED™ (eSQUED™). The device/software poses no risk and is non-invasive.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autism | – | Device: SQUED™ series 28.1 home-useIndividuals 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. |
Who may qualify
- Ages
- 1 month to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (18 listed)
- Clinical diagnosis of autism or related conditions.
- History of Late complications at Natal Trauma:
- 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:
- Presence on the Skin of the interruption of Autowave front (interruption of hair separatrix - dorsal/ventral) and/or of the Autowave Reverberators:
Key exclusion criteria (4 listed)
- 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™).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SQUED™ series 28.1 home-useSemiconducting 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! | Device | Autism |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- Center of Synergetics, Universität Stuttgart, GermanyLink provided by the sponsor.
- Headquarters of World Organization of Medical Synergetics, Lviv - Solonka ( 49°45'56.6"N 23°59'53.7"E )Link provided by the sponsor.
- Yaroshuk's Scientific Medical SchoolLink provided by the sponsor.
- Autowave processes in Medicine - bookLink provided by the sponsor.
- Nonlinear Control - bookLink provided by the sponsor.
- Drift of spiral wave in excitable mediaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. This will be administered by Presence of Clinical protocol CRF-SQUED™ and creation Active medium SQUED™ of Patient.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuliya Yaroshuk, M.D.s. Ph.D. principal investigator
World Autism Center, American Federation of Medical Synergetics, Department of Neurology; Cognitive Neurology/Neuropsychology WOMS
Yuriy Fihol, M.D.s. Ph.D. principal investigator
Clinic of Synergetics, Department of Neurology; Cognitive Neurology/Neuropsychology of the World Organization of Medical Synergetics
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autistic Disorder and Autism Spectrum Disorder, run by American Federation of Medical Synergetics at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuliya Yaroshuk, M.D.s. Ph.D. (502-338-0861, Dr.Yuliya.Yaroshuk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SQUED™ software of patient (time frame: Personal Autowave Diagnostics/Personal Autowave Therapy - through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017; AzTrials last refreshed its copy on 26 Oct 2026.