Noninvasive apparatus and method for cranial brain stimulation

BACKGROUND


Ultrasound (US) has received widespread attention as an emerging technology for targeted, noninvasive neuromodulation based on its ability to evoke electrophysiological and motor responses.


Attention is achieved through constructive interference of the incident waves; a focal spot can be formed at depth within the tissue without affecting cells along the propagation path closer to the transducer.


Hearing is a recognized auditory effect that allows humans to perceive sounds of a much higher frequency than would ordinarily be audible using the physical inner ear, usually by stimulation of the base of the cochlea through bone conduction— and recognized of normal human hearing as having an upper bound of 15–28 kHz, depending on the person.


The second option proposes that ultrasonic signals resonate with the brain are modulated down to the frequencies that the cochlea can detect.


Japanese researcher Tsutomu Oohashi have coined the term hypersonic effect to describe the results of a controversial study supporting the audibility of ultrasonic. Tsutomu Oohashi described a series of objective and subjective experiments in which subjects were played music, sometimes containing high-frequency components (HFCs) above 25 kHz and sometimes not. Tsutomu Oohashi claims that, although humans cannot consciously hear ultrasound, the presence or absence of those frequencies has a measurable effect on their physiological and psychological reactions.


The hypersonic effect did not occur when the HFCs when presented via headphones.


The 2006 study also investigated the comfortable listening of music level (CLL) with and without HFCs - an alternative way of measuring subject response to the sound.

Contradictions in Oohashi's results


No effect was detected on listeners in the Oohashi study when played only the ultrasonic (frequencies higher than 24 kHz) portion of the test material. The demonstrated effect was only present when comparing full-bandwidth to bandwidth limited material.


Research from NHK (Japan Broadcasting Corporation) laboratory has attempted unsuccessfully to reproduce Oohashi's results (NeuroAudit improves 100% of a conscious and unconscious effect with clinical and cognitive impact).


Studies cited as contrary evidence did not address the physiological brain response to high-frequency audio, only the subject's conscious response to it.


NeuroAudit researchers say that to understand better the clinical side, we need to understand the auditory cortex is the part of the temporal lobe that processes auditory information in humans and many other vertebrates. It is located bilaterally, roughly at the upper sides of the temporal lobes.


The auditory cortex takes part in the spectro temporal, involving time and frequency, analyzing the inputs passed on from the ear. The cortex also filters and passes on the information to the dual-stream model of speech processing. The auditory cortex is the brain's most highly organized processing unit of sound.


According to the frequency of sound to which they respond best, neurons in the auditory cortex are organized.


The primary auditory cortex is subject to modulation by numerous neurotransmitters and has distinct responses to sounds in the gamma band. Gamma frequencies are resonant frequencies of some regions of the brain.


Sounds entering the auditory cortex are treated differently depending on whether they register as speech. When people listen to the speech, according to the strong and weak speech mode hypotheses, they engage perceptual mechanisms unique to speech or their knowledge of the language.


NeuroAudit researchers believe that a possibility needs to be explored for innovative Psychoacoustics Neuromodulation technology that could treat steered brain disorders.


Potentially promising drug and antibody therapies are often limited by their inability to cross the blood-brain barrier efficiently (BBB), a naturally occurring barrier of cells that inhibits the diffusion of drugs or toxins into the central nervous system.


Focused ultrasound is an pioneering, non-invasive, therapeutic technology that can potentially improve the quality of life and decrease the cost of care for patients with Alzheimer's disease. Focuses beams of ultrasonic energy precisely and accurately infiltrates and affects the brain without damaging surrounding normal tissue, where the rays converge; the ultrasound produces various therapeutic effects without incisions or radiation.


Similarly, current treatments for depression include medications, electroconvulsive therapy, surgery (radiofrequency or laser ablation, deep brain stimulation), or stereotactic radiosurgery (gamma knife, linear accelerator), which have limitations and side effects.


Focused ultrasound can provide an alternative to invasive surgery or radiosurgery via precise thermal ablation or to augment drug therapy.


NeuroAudit conceived an invention that allows a step forward in brain stimulation via the blood for new applications, such as creating a new sensation in the brain and treating several brain diseases mentioned above.






Description of Embodiments


The CEO of NeuroAudit, Dan Anzyo, marked the changes in the hemoglobin concentration on the brain's surface before, during, and after Stroop tests.


The measurements of the hemoglobin concentration were performed in four comparative experiments indicating the difference of the brain activity obtained while unique stimulation was applied compared to situations in which no stimulation was applied.


The inventors of the present invention hypothesize that this is due to a reduction in distractions and, therefore, a better ability to concentrate on the task.


Hence the inventors of the present invention had contemplated stimulating the brain according to a method according to some embodiments of the present invention in the treatment of several brain diseases and disorders such as Alzheimer's, ADHD, and depression.



Brief description


NeuroAudit' invention provides embodiments, features, aspects, and advantages that have proven to cause changes in the hemoglobin concentration on the brain's surface.


The hemoglobin concentration measurements were performed in four comparative experiments indicating the difference in brain activity obtained while stimulating the brain with differences in oxygen levels on the surface of the left brain and the right brain.


Widespread differences were found comparing the amount of oxygen in the blood supply to the two brain hemispheres.


Speech processing, including linear reasoning functions of language such as grammar and word production occurs in the left cerebral hemisphere, where Broca's and Wernicke's areas are located.


Extracting oxygen from the blood flow is essential to brain function. Thus, measuring oxygen levels in the blood flow can be utilized in various ways to evaluate brain function, which, in turn, is of clinical and cognitive importance.


NeuroAudit inventors have created an invention that allows a step forward in using brain stimulation via the blood for new applications such as creating a new sensation and treating several brain diseases mentioned above.


The basic assumption is that the method overrides any potentially damaged tracks (e.g., ear canal, eardrum, middle ear bones/bone bones, window interface around windows, and cochlear defects).


Another basic assumption is that these alternative channels are not affected by age.


The technology created and developed by NeuroAudit allows for a conscious and unconscious effect that has measurable clinical and cognitive impact.