跳至主要内容
临床试验/NCT03222375
NCT03222375招募中不适用

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

American Federation of Medical Synergetics2 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2017年9月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
2
主要终点
SQUED™ software of patient

研究概览

简要总结

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.

详细描述

Autowave Reverberator:

  1. 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. 2. 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:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Month 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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);
  • 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.

排除标准

  • 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™).

结局指标

主要结局

SQUED™ software of patient

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
American Federation of Medical Synergetics
申办方类型
Other
责任方
Sponsor

研究点 (2)

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