New MRT Imaging Biomarkers and Treatment With Kinetic Oscillatory Stimulation (KOS) in Nasal Cavity for ME/CFS, underway, Karolinska University

Sly Saint

Sly Saint

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New MRT Imaging Biomarkers and Treatment With Kinetic Oscillatory Stimulation (KOS) in Nasal Cavity for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Published on BioPortfolio: 2018-04-19T10:10:22-0400

Summary
Placebo controlled trial study of efficacy of Kinetic Oscillation Stimulation (KOS) in nasal cavity will be conducted in patients with myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The outcome of the treatment will be assessed with clinical evaluation of patients, cognitive tests, structural and functional MRI of the brain.

Description
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a neurologic disease that is characterized by extreme physical and mental fatigue. Although some signs of inflammation have been reported previously in ME/CFS patients, the data have been quite limited and controversial. A recent study based on multiplex array of a Luminex system has demonstrated an immune signature of serum cytokines that is correlated with the disease severity and fatigue duration. Results from resting-state functional MRI (fMRI) studies have also demonstrated that there is a significant correlation between the degree of chronic fatigue and reduction of functional network connectivity in the brain.

The autonomic nervous system (ANS) plays an important role in the regulation of systemic inflammation. The nasal cavity has a rich innervation of cranial nerves. We have recently developed a non-invasive ANS stimulation technique, called Kinetic Oscillation Stimulation (KOS) in the nasal cavity. KOS treatment is expected to have a positive impact on systemic inflammation via the restoration of ANS homeostasis.

With this double blinded, placebo controlled, clinical trial, the efficacy of KOS treatment on ME/CFS will be assessed by clinical evaluation, multiplex immunoassay of peripheral blood samples, performance of psychomotor vigilance task, structural and functional MRI of the brains at the baseline point before KOS treatment and after the completion of KOS treatment period.
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https://www.bioportfolio.com/resour...h-Kinetic-Oscillatory-Stimulation-KOS-in.html

Sponsor:
Karolinska University Hospital
Information provided by (Responsible Party):
Tie-Qiang Li, Karolinska University Hospital


Recruitment Status : Recruiting
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 15, 2020

https://clinicaltrials.gov/ct2/show/results/NCT03502044?view=results



 
Sounds like basically just the tapping "therapy" using some gizmo to tap inside the nose, just so it's more "scientific" and also so people need to buy their gizmo. Oh there'll be frequencies and amplitudes and stuff, but......

(not that I know anything about it but the idea that ME can be cured by tapping, makes me want to stand on a circle and shout things)
 
To be double blind, they would need to stimulate the autonomic nervous system without the person noticing. That seems quite a hard thing to do. Generally speaking stimulation of the autonomic nervous system produces obvious symptoms, like diarrhoea or fainting or a cold sweat!
 
Chordate Medical has developed a treatment method called “Kinetic Oscillation Stimulation” (KOS).
This method represents a new way to treat Non-allergic rhinitis that does not require the use of surgery, anesthesia or pharmaceuticals.
The KOS method has been developed to treat patients with NAR. The method consists of inserting a balloon catheter into each nostril for ten minutes at a time. The balloon catheter is inflated with air to a pre-set pressure and is then set to vibrate at a specific frequency using a computer-controlled system.
Treatment with the Chordate system has been demonstrated to be safe and well tolerated.¹

A single treatment last during a short period of time and can be administered by a doctor or nurse in an out-patient clinic. Although symptoms often improve with just a single treatment, studies have shown the treatment effect is increased if the patient receives two consecutive treatments 4 weeks apart.

The latest clinical study for treatment of non-allergic rhinitis showed a 55 % improvement in nasal congestion symptom score after 8 weeks for patients who received two treatments. Six month follow-up still showed significant improvement. The positive effects of KOS can be maintained for several months. Significant improvements in TVRSS (Total Vasomotor Rhinitis Symptom Score) and SNOT 22 were found.²
Rhinitis symptoms impact patients’ daily functioning and quality of life. The performance endpoints, and associated variables and measurements, are consequently subject self-reported. Monitoring of patients showed that many had residual improvement to their symptoms more than twelve months after treatment.³
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I wonder what made them think a vibrating ballon catheter for treating rhinitis would effectively treat ME? I mean, that would be great, but, erm, unlikely.
 
Jonathan Edwards said:
To be double blind, they would need to stimulate the autonomic nervous system without the person noticing. That seems quite a hard thing to do. Generally speaking stimulation of the autonomic nervous system produces obvious symptoms, like diarrhoea or fainting or a cold sweat!
Click to expand...
Not sure about the ethics of this suggestion, but if you did stimulate the autonomic nervous system in that way, could you accompany it with an inert pill, but tell the trial participants it might have side effects akin to your "obvious symptoms"? Or am I missing the point here?
 
Their application to the ethics review board has a lot of details about the hows and the whys (47 pages, all in Swedish).

Here are some excerpts:

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kos2.png
kos3.png

(Edited to replace image links with uploaded image files.)
 
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