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Transcutaneous Vagus Nerve Stimulation for the Treatment of Lupus (TRUST)

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ClinicalTrials.gov Identifier: NCT02917265
Recruitment Status : Terminated (poor recruitment)
First Posted : September 28, 2016
Last Update Posted : December 28, 2018
Sponsor:
Collaborators:
Oklahoma Medical Research Foundation
University of Oklahoma
Information provided by (Responsible Party):
Aikaterini Thanou, Oklahoma Medical Research Foundation

Tracking Information
First Submitted Date  ICMJE March 28, 2016
First Posted Date  ICMJE September 28, 2016
Last Update Posted Date December 28, 2018
Study Start Date  ICMJE September 2015
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 26, 2018)
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 ]
BICLA requires meeting all of the following parameters:
  1. All BILAG A scores improving to B/C/D and all BILAG level B scores improving to C/D
  2. No single new BILAG A & not >1 new BILAG B scores, no worsening of baseline SLEDAI total score AND no worsening in PGA (<10% worsening from baseline)
  3. No initiation of non-protocol treatments or premature study discontinuation
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT02917265 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 26, 2018)
  • Percentage of participants on active vs sham tVNS with improvement in SLE disease activity by the Systemic lupus erythematosus Responder Index (SRI) [ Time Frame: 12 weeks ]
    SRI requires meeting all of the following parameters:
    1. ≥4-point reduction from baseline in SLEDAI score
    2. No single new BILAG A & not >1 new BILAG B scores AND no worsening in PGA (<10% worsening from baseline)
    3. No initiation of non-protocol treatments or premature study discontinuation
  • Percentage of participants on active vs sham tVNS with improvement in heart rate variability [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: December 26, 2018)
  • Percentage of participants on active vs sham tVNS that experience an SLE flare by SELENA SLEDAI flare index [ Time Frame: 12 weeks ]
  • Percentage of participants on active vs sham tVNS with improvement in quality of life measured by the Lupus QoL [ Time Frame: 12 weeks ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcutaneous Vagus Nerve Stimulation for the Treatment of Lupus
Official Title  ICMJE Transcutaneous Vagus Nerve Stimulation for the Treatment of Systemic Lupus Erythematosus
Brief Summary This is a 3-month double blinded randomized controlled study of transcutaneous electrical vagus nerve stimulation (tVNS) compared to a sham stimulation for the treatment of patients with active systemic lupus erythematosus.
Detailed Description Patients with SLE and active, non-organ-threatening disease are eligible to participate in this prospective randomized double blind trial of active or sham transcutaneous electrical vagus nerve stimulation (tVNS). Active tNVS is performed by the use of a transcutaneous electrical nerve stimulation (TENS) device with electrodes attached to an area of the external ear innervated by the auricular branch of the vagus nerve. The same protocol is followed in the sham tVNS arm, but the pads are placed on an area of the external ear that is devoid of vagus innervation.TENS is applied for 60 to 120 minutes daily as tolerated and participants keep a detailed log of their daily TENS sessions. Patients return to clinic at weeks 4, 8 and 12 for study related assessments.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE
  • Device: TENS for vagus stimulation
    TENS electrodes are applied on an area of the external ear innervated by the auricular branch of the vagus nerve.
  • Device: TENS for sham stimulation
    TENS electrodes are applied on an area of the external ear devoid of vagus innervation.
Study Arms  ICMJE
  • 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.
    Intervention: Device: TENS for vagus stimulation
  • Sham Comparator: TENS for sham stimulation
    A TENS unit is applied to an area of the external ear that is devoid of vagus innervation.
    Intervention: Device: TENS for sham stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 26, 2018)
8
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2018
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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.
  2. Positive antinuclear antibody or anti-dsDNA within one year of screening
  3. 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
  4. 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:

  1. 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
  2. Active CNS lupus affecting mental status
  3. 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
  4. Rituximab treatment within 6 months prior to screening and/or without return of B cells to baseline levels
  5. Treatment with cyclophosphamide within a month prior to screening
  6. Treatment with any investigational drug within 3 months or 5 half-lives whichever is longer
  7. Recurrent vaso-vagal syncopal episodes
  8. Unilateral or bilateral vagotomy
  9. Presence of any evidence of vagus nerve pathology or injury
  10. Heart failure (NYHA class III or IV)
  11. 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.
  12. Valvular and other structural heart disease that is evident by transthoracic echocardiogram and is associated with heart failure (NYHA class III or IV)
  13. 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
  14. 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
  15. 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
  16. All diagnosed syndromes affecting the central nervous system (CNS) or autonomic nervous system
  17. Major psychiatric disorders including evidence of major depressive disorder (DSM-5 diagnostic criteria) that is not currently controlled by medications
  18. Hemoglobin below 9.0 gm/dL (by the most recent CBC)
  19. Pregnancy or breast feeding
  20. Inability or unwillingness to understand and/or sign informed consent
  21. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02917265
Other Study ID Numbers  ICMJE H15-141
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aikaterini Thanou, Oklahoma Medical Research Foundation
Study Sponsor  ICMJE Aikaterini Thanou
Collaborators  ICMJE
  • Oklahoma Medical Research Foundation
  • University of Oklahoma
Investigators  ICMJE
Principal Investigator: Aikaterini Thanou, MD Oklahoma Medical Research Foundation
PRS Account Aikaterini Thanou
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP