Myalgic EncephalomyelitisNCT03502044
New MRT Imaging Biomarkers and Treatment With Kinetic Oscillatory Stimulation (KOS) in Nasal Cavity for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
A study testing Inactive Kinetic Oscillation Stimulation (KOS) and Active Kinetic Oscillation Stimulation (KOS) in people with Myalgic Encephalomyelitis and Chronic Fatigue Syndrome, run by Karolinska University Hospital at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myalgic Encephalomyelitis, Chronic Fatigue Syndrome
- What is being tested?
- Inactive Kinetic Oscillation Stimulation (KOS) and Active Kinetic Oscillation Stimulation (KOS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 17 Apr 2018to 15 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) established by Consultant in Neurology.
Who cannot join
- Any cardiovascular disease.
- Any other condition considered by the physician to render the patient unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Neurological Rehabilitation Clinic in Stora Sköndal
Stockholm
Per Julin, MD, PhD, 0046840029131, per.julin@ki.se
About this study
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.
Read the 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.
- Being tested
- Inactive Kinetic Oscillation Stimulation (KOS), Active Kinetic Oscillation Stimulation (KOS)
- Keywords
- Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, Kinetic Oscillatory Stimulation in nasal cavity
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactive Kinetic Oscillation Stimulation (KOS)Device
10 minutes inactive KOS treatment in each nasal cavity.
Active Kinetic Oscillation Stimulation (KOS)Device
10 minutes active KOS treatment in each nasal cavity.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1, active KOS treatment | Active comparator | 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. Receives: Device: Active Kinetic Oscillation Stimulation (KOS) |
| Arm 2, 8 inactive KOS treatments then 8 active KOS treatments | Placebo comparator | 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. Receives: Device: Inactive Kinetic Oscillation Stimulation (KOS); Device: Active Kinetic Oscillation Stimulation (KOS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline before KOS intervention, immediately after every second KOS treatment, 3 months after last KOS treatment.
Secondary outcomes (5)
Diagnostic MRI of the brain
Functional MRI of the brain at 3T
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline before KOS intervention, immediately after 8 treatments, immediately after 16 treatments, 3 months after the last treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start17 Apr 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion15 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myalgic EncephalomyelitisStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tie-Qiang Li, Karolinska University Hospital
- Investigators
- Per Julin, MD, PhD, Study director, Neurological Rehabilitation Clinic in Stora Sköndal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502044
- Sponsor's protocol ID
- KarolinskaUH2018
- Status last verified
- Apr 2018
- First submitted
- 23 Mar 2018
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New MRT Imaging Biomarkers and Treatment With Kinetic Oscillatory Stimulation (KOS) in Nasal Cavity for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
- ClinicalTrials.gov ID
- NCT03502044
- Acronym / sponsor ID
- KarolinskaUH2018
- Keywords
- Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, Kinetic Oscillatory Stimulation in nasal cavity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 15 Jun 2020 (estimated)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1, active KOS treatment | Active comparator | Device: Active Kinetic Oscillation Stimulation (KOS)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 2, 8 inactive KOS treatments then 8 active KOS treatments | Placebo comparator | Device: Inactive Kinetic Oscillation Stimulation (KOS), Device: Active Kinetic Oscillation Stimulation (KOS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) established by Consultant in Neurology.
Key exclusion criteria (2 listed)
- Any cardiovascular disease.
- Any other condition considered by the physician to render the patient unsuitable for participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inactive Kinetic Oscillation Stimulation (KOS)10 minutes inactive KOS treatment in each nasal cavity. | Device | Arm 2, 8 inactive KOS treatments then 8 active KOS treatments |
| Active Kinetic Oscillation Stimulation (KOS)10 minutes active KOS treatment in each nasal cavity. | Device | Arm 1, active KOS treatment, Arm 2, 8 inactive KOS treatments then 8 active KOS treatments |
Primary outcome
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.
5 secondary outcomes
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)
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)
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.
ME/CFS symptom rating scale
Time frame: At baseline before KOS intervention, immediately after every second KOS treatment, 3 months after last KOS treatment.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Julin, MD, PhD study director
Neurological Rehabilitation Clinic in Stora Sköndal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inactive Kinetic Oscillation Stimulation (KOS) and Active Kinetic Oscillation Stimulation (KOS) in people with Myalgic Encephalomyelitis and Chronic Fatigue Syndrome, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tie-Qiang Li, MSc, PhD (0046707374215, Tie-qiang.li@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fatigue severity scale (time frame: Baseline before KOS intervention, immediately after every second KOS treatment, 3 months after last KOS treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.