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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Fatigue Syndrome; Myalgic Encephalomyelitis
• Intervention / Treatment: Device: Active Kinetic Oscillation Stimulation (KOS); Device: Inactive Kinetic Oscillation Stimulation (KOS)

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
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Neurological Rehabilitation Clinic in Stora Sköndal
    • Contact: Per Julin, MD, PhD; Phone Number: 0046840029131; Email: per.julin@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1, active KOS treatment; 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.	Device: Active Kinetic Oscillation Stimulation (KOS); 10 minutes active KOS treatment in each nasal cavity.
Placebo Comparator: Arm 2, 8 inactive KOS treatments then 8 active KOS treatments; Patients in arm 2 receive inactive KOS treatment during the first 8 KOS treatments of the study. Thereafter patients in arm 2 receive 8 active KOS treatments. Patients receive KOS treatments twice a week during 8 consecutive weeks.	Device: Active Kinetic Oscillation Stimulation (KOS); 10 minutes active KOS treatment in each nasal cavity.; Device: Inactive Kinetic Oscillation Stimulation (KOS); 10 minutes inactive KOS treatment in each nasal cavity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fatigue severity scale	A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity according to a self-report scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. Maximum score possible is 63.	Baseline before KOS intervention, immediately after every second KOS treatment, 3 months after last KOS treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic MRI of the brain	Functional MRI of the brain at 3T	At baseline before KOS intervention and within 4 weeks after the last KOS intervention (16 KOS interventions are given during 8 consecutive weeks)
Signature of systemic inflammation and severity	Analysis of high dimensional immune signature from peripheral venous blood samples using mass cytometry.	At baseline before KOS intervention and within 4 weeks after the last KOS intervention (16 KOS interventions are given during 8 consecutive weeks)
SF-36 PHYSICAL FUNCTIONING SUBSCALE (PF-10) SF-36 Physical Functioning Subscale (PF-10)	The PF-10 is a generic outcome measure designed to examine a person's perceived limitation with physical functioning and is a subscale within the Medical Outcomes Study 36-item Short Form Health Survey (SF-36). There are 10 items, each item is rated on a 3-point scale.	At baseline before KOS intervention, immediately after 8 treatments, immediately after 16 treatments, 3 months after the last treatment.
ME/CFS symptom rating scale	Series of questions regarding ME/CFS symptoms graded 0-5 to evaluate degree of disease burden, according to the diagnostic Canadian Criteria.	At baseline before KOS intervention, immediately after every second KOS treatment, 3 months after last KOS treatment.
Hospital anxiety depression scale (HADS)	The questionnaire comprises 7 questions for anxiety and 7 questions for depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.	At baseline before KOS intervention, immediately after 8 treatments, immediately after 16 treatments, 3 months after the last treatment.

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Investigators: Study Director: Per Julin, MD, PhD, Neurological Rehabilitation Clinic in Stora Sköndal

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): June 15, 2020

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): April 19, 2018
• Last Update Submitted That Met QC Criteria: April 18, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Chronic Fatigue Syndrome; Myalgic Encephalomyelitis; Kinetic Oscillatory Stimulation in nasal cavity
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Pain; Neurologic Manifestations; Disease; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Central Nervous System Infections; Syndrome; Fatigue; Myalgia; Fatigue Syndrome, Chronic; Encephalomyelitis
• Other Study ID Numbers: KarolinskaUH2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No