New MRT Imaging Biomarkers and Treatment With Kinetic Oscillatory Stimulation (KOS) in Nasal Cavity for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
NCT ID: NCT03502044
Last Updated: 2018-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2018-04-17
2020-06-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
During the following 8 treatments only the patients, not the investigator, are blinded.
Study Groups
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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.
Active Kinetic Oscillation Stimulation (KOS)
10 minutes active KOS treatment in each nasal cavity.
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.
Inactive Kinetic Oscillation Stimulation (KOS)
10 minutes inactive KOS treatment in each nasal cavity.
Active Kinetic Oscillation Stimulation (KOS)
10 minutes active KOS treatment in each nasal cavity.
Interventions
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Inactive Kinetic Oscillation Stimulation (KOS)
10 minutes inactive KOS treatment in each nasal cavity.
Active Kinetic Oscillation Stimulation (KOS)
10 minutes active KOS treatment in each nasal cavity.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Any other condition considered by the physician to render the patient unsuitable for participation in the study.
18 Years
ALL
No
Sponsors
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Karolinska University Hospital
OTHER
Responsible Party
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Tie-Qiang Li
Adjunct Professor
Principal Investigators
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Per Julin, MD, PhD
Role: STUDY_DIRECTOR
Neurological Rehabilitation Clinic in Stora Sköndal
Locations
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Neurological Rehabilitation Clinic in Stora Sköndal
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KarolinskaUH2018
Identifier Type: -
Identifier Source: org_study_id
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