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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)

NCT03502044 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2018-04-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Per Julin, MD, PhD · Neurological Rehabilitation Clinic in Stora Sköndal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-17
Primary Completion
2019-12-31
Completion
2020-06-15

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03502044 on ClinicalTrials.gov