Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Rigshospitalet, Denmark
With
Aalborg University Hospital
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Reading and understanding Danish.
SLE diagnosis based on SLE disease classification criteria for at least 1 year.
Stable disease and medication the past 28 days as defined by:
* No change in disease modifying antirheumatic drugs or biological therapy,
* Receiving maximally 10 mg prednisone daily.
Having signs of fatigue, as assessed by scoring ≤ 40 in the FACIT-Fatigue questionnaire.
Having signs of autonomic dysfunction, as assessed by scoring one or more of:
1. VAGUS score ≥1
2. SUDOSCAN score \< 50µS for hands or \< 70µS for feet
3. COMPASS-31 score \> 12
Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.
Sign the dated informed consent documents
You may not be if
Significant cardiovascular disease, including congenital cardiac disease, congestive heart failure, known severe coronary artery disease, or recent myocardial infarction (within 5 years), as assessed by a physician at the screening.
Blood pressure \< 100/60 or \> 160/105
Clinically significant bradycardia or tachycardia
History of abnormal baseline ECG, prolonged QT interval or arrhythmia
Previous surgery on the vagus nerve or abnormal cervical anatomy
Implanted or portable electro-mechanical medical devices, e.g. pacemaker, defibrillator, cochlear implant and infusion pump
Metallic device such as a stent, bone plate or bone screw implanted at or near the neck
Receiving active laser treatment for proliferative retinopathy
Active cancer or cancer in remission
History of brain tumor, aneurysm, bleed, head trauma, clinically significant syncope or seizures
Any clinical abnormalities that, in the opinion of the investigator, may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
Participation in other clinical trials less than three months prior to inclusion, unless such a participation is judged to have no influence on the recordings
Female pregnancy (positive urine-HCG), ongoing lactation or intended pregnancy during the study period.
* A pregnancy test is conducted at first and last visit to ensure that fertile female patients are not pregnant during the study period.
* Further, the investigator ensures that fertile female patients use a safe contraception method during the study and for at least 15 hours after termination of the study period. Safe contraception: The combined oral contraceptive pill; intra uterine device; gestagen injection; subdermal implantation; hormone vaginal ring; and transdermal plaster.
Male patients who intend to father a child during the course of the study
