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

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Brief Title

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

Official Title

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

Brief 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.
    

Detailed 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.
    


Study Type

Interventional


Primary Outcome

Change in Fatigue severity scale

Secondary Outcome

 Diagnostic MRI of the brain

Condition

Myalgic Encephalomyelitis

Intervention

Inactive Kinetic Oscillation Stimulation (KOS)

Study Arms / Comparison Groups

 Arm 1, active KOS treatment
Description:  Patients in arm 1 receive active KOS treatment throughout study, which means 16 active KOS treatments. Patients receive KOS treatments twice a week during 8 consecutive weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

200

Start Date

April 17, 2018

Completion Date

June 15, 2020

Primary Completion Date

December 31, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) established
             by Consultant in Neurology.

        Exclusion Criteria:

          -  Any cardiovascular disease.

          -  Any other condition considered by the physician to render the patient unsuitable for
             participation in the study.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Per Julin, MD, PhD, 0046707374215, [email protected]

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations


NCT ID

NCT03502044

Organization ID

KarolinskaUH2018


Responsible Party

Principal Investigator

Study Sponsor

Karolinska University Hospital


Study Sponsor

Per Julin, MD, PhD, Study Director, Neurological Rehabilitation Clinic in Stora Sköndal


Verification Date

April 2018