- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02917265
Transcutaneous Vagus Nerve Stimulation for the Treatment of Lupus (TRUST)
Transcutaneous Vagus Nerve Stimulation for the Treatment of Systemic Lupus Erythematosus
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Oklahoma Medical Research Foundation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with SLE age 18-70 meeting the American College of Rheumatology Classification Criteria. Patients need to meet a minimum of 4 out of 11 criteria simultaneously or serially on two separate occasions.
- Positive antinuclear antibody or anti-dsDNA within one year of screening
- Non-serological SLEDAI ≥4 or ≥1 BILAG B or A and presence of inflammatory arthritis (defined by at least 3 swollen and 3 tender joints) at screening
- Patients may receive on one or more of the following immune suppressive therapies: hydroxychloroquine, quinacrine, methotrexate, azathioprine, mycophenolate mofetil, tacrolimus, sirolimus, belimumab, abatacept. Immune suppressive medications should have been administered at stable doses for ≥30 days prior to baseline. Patients may also be on prednisone up to 10mg daily or equivalent steroid treatment at the baseline visit.
Exclusion Criteria:
- Acute lupus nephritis defined as class II,III, IV or V nephritis diagnosed within 6 months or prot/creat > 1.5 gm/gm due to active lupus or in process of receiving induction therapy for nephritis
- Active CNS lupus affecting mental status
- Any other organ threatening or life threatening manifestation of SLE as well as those, who, in the opinion of the investigator, have severe multi-organ or refractory lupus
- Rituximab treatment within 6 months prior to screening and/or without return of B cells to baseline levels
- Treatment with cyclophosphamide within a month prior to screening
- Treatment with any investigational drug within 3 months or 5 half-lives whichever is longer
- Recurrent vaso-vagal syncopal episodes
- Unilateral or bilateral vagotomy
- Presence of any evidence of vagus nerve pathology or injury
- Heart failure (NYHA class III or IV)
- Known atherosclerotic disease, including severe carotid artery disease, uncontrolled hypertension, uncontrolled diabetes, and history of myocardial infarction (MI), cardiomyopathy or stroke within the past year. Clinically stable patients with coronary artery disease, but no recent MI (within the past year) and no current symptoms of angina are not however excluded.
- Valvular and other structural heart disease that is evident by transthoracic echocardiogram and is associated with heart failure (NYHA class III or IV)
- Prolonged QT interval or abnormal baseline ECG - sick sinus syndrome, Mobitz type 2 second or third degree heart block, atrial fibrillation, atrial flutter, recent history of ventricular tachycardia or ventricular fibrillation or clinically significant premature ventricular contraction
- Individuals currently implanted with an electrical and/or neurostimulator device, such as cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant
- Known respiratory disease that has decreased any pulmonary function test more than 25% below expected values or has resulted in hospitalization within the past year
- All diagnosed syndromes affecting the central nervous system (CNS) or autonomic nervous system
- Major psychiatric disorders including evidence of major depressive disorder (DSM-5 diagnostic criteria) that is not currently controlled by medications
- Hemoglobin below 9.0 gm/dL (by the most recent CBC)
- Pregnancy or breast feeding
- Inability or unwillingness to understand and/or sign informed consent
- Any other medical condition, whether or not related to lupus, which, in the opinion of the investigator, would render the patient inappropriate or too unstable to complete the study protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TENS for vagus stimulation
A transcutaneous electrical nerve stimulation (TENS) unit is applied to an area of the external ear that is innervated by the auricular branch of the vagus nerve.
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TENS electrodes are applied on an area of the external ear innervated by the auricular branch of the vagus nerve.
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Sham Comparator: TENS for sham stimulation
A TENS unit is applied to an area of the external ear that is devoid of vagus innervation.
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TENS electrodes are applied on an area of the external ear devoid of vagus innervation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants on Active vs Sham tVNS With Improvement in SLE Disease Activity by the BILAG-based Combined Lupus Assessment (BICLA)
Time Frame: 12 weeks
|
Achieving a BICLA response requires to meet all of the following parameters:
The range of values for the above instruments are listed below, with higher scores indicating more active disease: BILAG: 0 to 96 SLEDAI: 0 to 105 PGA: 0-3 |
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants on Active vs Sham tVNS With Improvement in SLE Disease Activity by the Systemic Lupus Erythematosus Responder Index (SRI-4)
Time Frame: 12 weeks
|
SRI requires meeting all of the following parameters:
The range of values for the above instruments are listed below, with higher scores indicating more active disease: BILAG: 0 to 96 SLEDAI: 0 to 108 PGA: 0-3 |
12 weeks
|
Percentage of Participants on Active vs Sham tVNS With Improvement in Heart Rate Variability (HRV)
Time Frame: 12 weeks
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HRV is measured by time domain (RMSSD and pNN50) and frequency domain [high frequency (HF), low to high frequency (LF/HF) ratio] parameters.
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12 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants on Active vs Sham tVNS That Experience an SLE Flare by SELENA SLEDAI Flare Index
Time Frame: 12 weeks
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The SELENA SLEDAI flare index captures flares in the preceding 30 days by a combination of clinical descriptors and medications rules.
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12 weeks
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Percentage of Participants on Active vs Sham tVNS With Improvement in Quality of Life Measured by the Lupus QoL
Time Frame: 12 weeks
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The Lupus QoL is a patient reported outcome developed for measurement of quality of life of patients with SLE in clinical research
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12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aikaterini Thanou, MD, Oklahoma Medical Research Foundation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H15-141
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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