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

NCT03502044 | Unknown

• 1 other identifier: KarolinskaUH2018
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Myalgic Encephalomyelitis; Chronic Fatigue Syndrome

Keywords

Myalgic Encephalomyelitis; Chronic Fatigue Syndrome; Kinetic Oscillatory Stimulation in nasal cavity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Diagnostic MRI of the brain

  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

  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)

  At baseline before KOS intervention, immediately after 8 treatments, immediately after 16 treatments, 3 months after the last treatment.

• ME/CFS symptom rating scale

  At baseline before KOS intervention, immediately after every second KOS treatment, 3 months after last KOS treatment.

• Hospital anxiety depression scale (HADS)

  At baseline before KOS intervention, immediately after 8 treatments, immediately after 16 treatments, 3 months after the last treatment.

Study Arms (2)

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.

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.

Device: Inactive Kinetic Oscillation Stimulation (KOS); Device: Active Kinetic Oscillation Stimulation (KOS)

Interventions

Inactive Kinetic Oscillation Stimulation (KOS) DEVICE

10 minutes inactive KOS treatment in each nasal cavity.

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

Active Kinetic Oscillation Stimulation (KOS) DEVICE

10 minutes active KOS treatment in each nasal cavity.

Arm 1, active KOS treatment; Arm 2, 8 inactive KOS treatments then 8 active KOS treatments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) established by Consultant in Neurology.

You may not qualify if:

• Any cardiovascular disease.
• Any other condition considered by the physician to render the patient unsuitable for participation in the study.

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Neurological Rehabilitation Clinic in Stora Sköndal

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Per Julin, MD, PhD

  Neurological Rehabilitation Clinic in Stora Sköndal

  STUDY DIRECTOR

Central Study Contacts

Tie-Qiang Li, MSc, PhD

CONTACT

0046707374215; Tie-qiang.li@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Model Details: Double blinded placebo controlled trial design during the first 8 treatments. Single blinded (patient is blinded) controlled trial design during the last 8 treatments.

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: April 18, 2018
• Study Start: April 17, 2018
• Primary Completion: December 31, 2019
• Study Completion: June 15, 2020
• Last Updated: April 19, 2018

Record last verified: 2018-04

Locations

SE (1)