Status:
COMPLETED
Vagus Nerve Stimulation for Systemic Lupus Erythematous
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Aalborg University Hospital
Conditions:
Systemic Lupus Erythematosus
Autonomic Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This trial uses a double blinded, randomized 1:1 (active:sham) placebo controlled, parallel group design, investigating the effects of transcutaneous vagus nerve stimulation (tVNS) in patients with sy...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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:
- VAGUS score ≥1
- SUDOSCAN score \< 50µS for hands or \< 70µS for feet
- 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
- Exclusion criteria
- 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
Exclusion
Key Trial Info
Start Date :
August 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2023
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05315739
Start Date
August 24 2022
End Date
August 23 2023
Last Update
September 26 2025
Active Locations (1)
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1
Rigshospitalet
Copenhagen, Denmark, 2100