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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)

Primary Purpose

Myalgic Encephalomyelitis, Chronic Fatigue Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Inactive Kinetic Oscillation Stimulation (KOS)
Active Kinetic Oscillation Stimulation (KOS)
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myalgic Encephalomyelitis focused on measuring Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, Kinetic Oscillatory Stimulation in nasal cavity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Neurological Rehabilitation Clinic in Stora SköndalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm 1, active KOS treatment

Arm 2, 8 inactive KOS treatments then 8 active KOS treatments

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Diagnostic MRI of the brain
Functional MRI of the brain at 3T
Signature of systemic inflammation and severity
Analysis of high dimensional immune signature from peripheral venous blood samples using mass cytometry.
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.
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.
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.

Full Information

First Posted
March 23, 2018
Last Updated
April 18, 2018
Sponsor
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03502044
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
June 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myalgic Encephalomyelitis, Chronic Fatigue Syndrome
Keywords
Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, Kinetic Oscillatory Stimulation in nasal cavity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigator
Masking Description
Both the participants and investigator are blinded with regarding the administration of KOS or placebo treatments during the first 8 treatments. During the following 8 treatments only the patients, not the investigator, are blinded.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1, active KOS treatment
Arm Type
Active Comparator
Arm 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.
Arm Title
Arm 2, 8 inactive KOS treatments then 8 active KOS treatments
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Inactive Kinetic Oscillation Stimulation (KOS)
Intervention Description
10 minutes inactive KOS treatment in each nasal cavity.
Intervention Type
Device
Intervention Name(s)
Active Kinetic Oscillation Stimulation (KOS)
Intervention Description
10 minutes active KOS treatment in each nasal cavity.
Primary Outcome Measure Information:
Title
Change in Fatigue severity scale
Description
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.
Time Frame
Baseline before KOS intervention, immediately after every second KOS treatment, 3 months after last KOS treatment.
Secondary Outcome Measure Information:
Title
Diagnostic MRI of the brain
Description
Functional MRI of the brain at 3T
Time Frame
At baseline before KOS intervention and within 4 weeks after the last KOS intervention (16 KOS interventions are given during 8 consecutive weeks)
Title
Signature of systemic inflammation and severity
Description
Analysis of high dimensional immune signature from peripheral venous blood samples using mass cytometry.
Time Frame
At baseline before KOS intervention and within 4 weeks after the last KOS intervention (16 KOS interventions are given during 8 consecutive weeks)
Title
SF-36 PHYSICAL FUNCTIONING SUBSCALE (PF-10) SF-36 Physical Functioning Subscale (PF-10)
Description
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.
Time Frame
At baseline before KOS intervention, immediately after 8 treatments, immediately after 16 treatments, 3 months after the last treatment.
Title
ME/CFS symptom rating scale
Description
Series of questions regarding ME/CFS symptoms graded 0-5 to evaluate degree of disease burden, according to the diagnostic Canadian Criteria.
Time Frame
At baseline before KOS intervention, immediately after every second KOS treatment, 3 months after last KOS treatment.
Title
Hospital anxiety depression scale (HADS)
Description
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.
Time Frame
At baseline before KOS intervention, immediately after 8 treatments, immediately after 16 treatments, 3 months after the last treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tie-Qiang Li, MSc, PhD
Phone
0046707374215
Email
Tie-qiang.li@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Julin, MD, PhD
Organizational Affiliation
Neurological Rehabilitation Clinic in Stora Sköndal
Official's Role
Study Director
Facility Information:
Facility Name
Neurological Rehabilitation Clinic in Stora Sköndal
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Per Julin, MD, PhD
Phone
0046840029131
Email
per.julin@ki.se

12. IPD Sharing Statement

Learn more about this trial

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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