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Trial record 4 of 109 for:    cfs

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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ClinicalTrials.gov Identifier: NCT03502044
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Tie-Qiang Li, Karolinska University Hospital

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.

Condition or disease Intervention/treatment Phase
Myalgic Encephalomyelitis Chronic Fatigue Syndrome Device: Inactive Kinetic Oscillation Stimulation (KOS) Device: Active Kinetic Oscillation Stimulation (KOS) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Investigator)
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.

Primary Purpose: Treatment
Official Title: New MRT Imaging Biomarkers and Treatment With Kinetic Oscillatory Stimulation (KOS) in Nasal Cavity for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
Actual Study Start Date : April 17, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 15, 2020

Resource links provided by the National Library of Medicine


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: Inactive Kinetic Oscillation Stimulation (KOS)
10 minutes inactive KOS treatment in each nasal cavity.

Device: Active Kinetic Oscillation Stimulation (KOS)
10 minutes active KOS treatment in each nasal cavity.




Primary Outcome Measures :
  1. Change in Fatigue severity scale [ Time Frame: Baseline before KOS intervention, immediately after every second KOS treatment, 3 months after last KOS treatment. ]
    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 :
  1. Diagnostic MRI of the brain [ 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) ]
    Functional MRI of the brain at 3T

  2. Signature of systemic inflammation and severity [ 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) ]
    Analysis of high dimensional immune signature from peripheral venous blood samples using mass cytometry.

  3. SF-36 PHYSICAL FUNCTIONING SUBSCALE (PF-10) SF-36 Physical Functioning Subscale (PF-10) [ Time Frame: At baseline before KOS intervention, immediately after 8 treatments, immediately after 16 treatments, 3 months after the last treatment. ]
    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.

  4. ME/CFS symptom rating scale [ Time Frame: At baseline before KOS intervention, immediately after every second KOS treatment, 3 months after last KOS treatment. ]
    Series of questions regarding ME/CFS symptoms graded 0-5 to evaluate degree of disease burden, according to the diagnostic Canadian Criteria.

  5. Hospital anxiety depression scale (HADS) [ Time Frame: At baseline before KOS intervention, immediately after 8 treatments, immediately after 16 treatments, 3 months after the last treatment. ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03502044


Contacts
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Contact: Tie-Qiang Li, MSc, PhD 0046707374215 Tie-qiang.li@ki.se

Locations
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Sweden
Neurological Rehabilitation Clinic in Stora Sköndal Recruiting
Stockholm, Sweden
Contact: Per Julin, MD, PhD    0046840029131    per.julin@ki.se   
Sponsors and Collaborators
Karolinska University Hospital
Investigators
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Study Director: Per Julin, MD, PhD Neurological Rehabilitation Clinic in Stora Sköndal

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Responsible Party: Tie-Qiang Li, Adjunct Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT03502044     History of Changes
Other Study ID Numbers: KarolinskaUH2018
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tie-Qiang Li, Karolinska University Hospital:
Myalgic Encephalomyelitis
Chronic Fatigue Syndrome
Kinetic Oscillatory Stimulation in nasal cavity
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Myalgia
Encephalomyelitis
Syndrome
Fatigue
Disease
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Central Nervous System Infections
Musculoskeletal Pain
Pain
Neurologic Manifestations