Clinical trial NCT03502044: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myalgic Encephalomyelitis
Chronic Fatigue Syndrome
Keywords: Myalgic Encephalomyelitis
Chronic Fatigue Syndrome
Kinetic Oscillatory Stimulation in nasal cavity
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded placebo controlled trial design during the first 8 treatments. Single blinded (patient is blinded) controlled trial design during the last 8 treatments.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Fatigue severity scale
timeFrame: Baseline before KOS intervention, immediately after every second KOS treatment, 3 months after last KOS treatment.
Secondary outcomes:
measure: Diagnostic MRI of the brain
timeFrame: At baseline before KOS intervention and within 4 weeks after the last KOS intervention (16 KOS interventions are given during 8 consecutive weeks)
measure: Signature of systemic inflammation and severity
timeFrame: At baseline before KOS intervention and within 4 weeks after the last KOS intervention (16 KOS interventions are given during 8 consecutive weeks)
measure: SF-36 PHYSICAL FUNCTIONING SUBSCALE (PF-10) SF-36 Physical Functioning Subscale (PF-10)
timeFrame: At baseline before KOS intervention, immediately after 8 treatments, immediately after 16 treatments, 3 months after the last treatment.
measure: ME/CFS symptom rating scale
timeFrame: At baseline before KOS intervention, immediately after every second KOS treatment, 3 months after last KOS treatment.
measure: Hospital anxiety depression scale (HADS)
timeFrame: At baseline before KOS intervention, immediately after 8 treatments, immediately after 16 treatments, 3 months after the last treatment.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Neurological Rehabilitation Clinic in Stora Sköndal
Study officials:
affiliation: Neurological Rehabilitation Clinic in Stora Sköndal
name: Per Julin, MD, PhD
role: STUDY_DIRECTOR
References: