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NCT Number: NCT06987565

Transcutaneous Vagus Nerve Stimulation in SLE

Systemic lupus erythematosus (SLE) is a chronic autoimmune inflammatory disease. Joint and muscle pain and fatigue are extremely common among patients and contribute to a reduced quality of life. Available therapies may be associated with significant side effects and many patients do not achieve an adequate response to these treatments. Therefore, there is an unmet need to develop new strategies to reduce pain and fatigue. Filling this need would significantly improve patients' quality of life. This trial will evaluate the effects of a novel approach, stimulating the vagus nerve, a nerve originating in the brain as a potential therapeutic intervention for treatment of musculoskeletal pain and fatigue. Vagus nerve stimulation has multiple beneficial effects and is one of the body's own ways to modulate the immune system. One can stimulate the vagus nerve via the skin at the neck or at specific locations in the ear, (transcutaneous vagus nerve stimulation: tcVNS). We recently completed a short, small scale randomized, placebo controlled trial of tcVNS in patients with SLE and observed dramatic benefits on musculoskeletal pain and fatigue. The treatment was safe without side effects. We are therefore proposing a longer trial to validate our initial findings and to look at durability. In this study, 18 patients with musculoskeletal pain will be followed for 2 months and will receive tcVNS or placebo (sham stimulation) for 5 minutes/day for 28 days. Patients will have a 1 out of 3 chance of receiving sham stimulation and neither the patient nor the evaluating investigator will know the actual treatment. The stimulations are self-administered, are non-painful and have not been associated with serious risks. After 28 days of stimulation, treatment will be discontinued and patients will be monitored for an additional 28 days to evaluate durability. Pain, fatigue and disease activity will be evaluated as well as possible side effects will be monitored throughout the trial. This study will also explore biologic mechanisms that may be responsible for the potential clinical effects. This will include possible effects of stimulation on gut permeability and the stool microbiome, areas that may play a significant role contributing to SLE disease and its manifestations. The development of an effective treatment without significant side effects would be extremely valuable and a significant advance for patients with SLE. If efficacious, tcVNS offers a non-toxic, non-immunosuppressive strategy to control two of the most common symptoms of this disease.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Feinstein Institutes for Medical Research

Manhasset, New York, 11030, United States

Location status: Recruiting

About this study

Musculoskeletal (MS) pain and fatigue are common symptoms of patients with Systemic Lupus Erythematosus (SLE) affecting up to 95% and contributing to a reduced quality of life. Safe and efficacious treatment remains an unmet need for these disease manifestations. Stimulation of the vagus nerve results in beneficial effects in patients. We recently completed a short , small scale, randomized, sham-controlled, double blind clinical trial of transcutaneous vagus nerve stimulation (taVNS) in patients with SLE. The clinical benefit on MS pain and fatigue was dramatic. We now propose a randomized sham controlled clinical trial assessing the efficacy and durability of a longer exposure to taVNS (28 days in comparison to the 4 day exposure in the previous trial) in 18 patients randomized 2: 1 with musculoskeletal pain. After 28 days of stimulation, the treatment will be discontinued and patients will be monitored for an additional 28 days to evaluate the treatment's durability. Pain, fatigue, disease activity (global and musculoskeletal) and safety will be evaluated and safety will be monitored throughout the trial. In this clinical trial we will also explore potential biologic mechanisms and pathways by which taVNS exerts ifs effects in SLE, including potential effects on gut permeability and the microbiome.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • SLE (defined by the ACR or SLICC criteria),
  • Musculoskeletal pain ≥ 4 on a non-anchored VAS 10 cm scale,
  • BILAG C or greater on the Musculoskeletal Domain of the BILAG 2004,
  • If on corticosteroids, the dose must be stable and ≤ 10 mg/day (prednisone or equivalent) for at least 14 days before baseline,
  • If on background immunosuppressive treatment the dose must be stable for at least 28 days before baseline,
  • If on NSAIDS, the dose must be stable for at least 7 days before baseline and the subject must be willing not to change the dose during the trial (except for toxicity),
  • Able and willing to give written informed consent and comply with the requirements of the study protocol.

Exclusion criteria

  • Initiation of immunosuppressive or antimalarial treatment within 3 months of baseline,
  • Treatment with cyclophosphamide within 2 months of baseline,
  • Initiation of anifrolumab within 3 months of baseline
  • Initiation of belimumab within 6 months of baseline,
  • Expectation to increase steroids and/or immunosuppressive treatment,
  • Anti-phospholipid syndrome,
  • Fibromyalgia,
  • Treatment with an anti-cholinergic medication, including over the counter medications,
  • Any implantable electronic devices including pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators,
  • Current tobacco or nicotine user (to limit potential confounding effects of exposure to nicotine),
  • Joint replacement within 60 days prior to study enrollment or planned within the course of the study,
  • Any planned surgical procedure requiring general anesthesia within the course of the study,
  • Intra-articular cortisone injections within 28 days of the start of study,
  • Chronic inflammatory disorders apart from SLE affecting the joints,
  • Investigational drug and/or treatment during the 28 days or seven half-lives of the investigational drug prior to the start of study drug dosing (Day 0), whichever is the greater length of time,
  • Active infection including hepatitis B or hepatitis C at baseline,
  • Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention,
  • Pregnancy or lactation (Pregnancy status will be determined via serum blood test & lactation will be determined via self-report),
  • Comorbid disease that has previously required administration of corticosteroid use,
  • Known allergy to mannitol or lactulose,
  • Chronic treatment with narcotic medication,
  • Prior receipt of transauricular vagus nerve stimulation in a clinical trial,
  • Inability to comply with study and follow-up procedures.

Treatment and study plan

Active vagus nerve stimulation

Device

Patients will receive transcutaneous stimulation of the vagus nerve for 5 minutes daily for 28 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes will be placed on the skin for stimulation. The electrical pulse generator is turned on and the amplitude of stimulation increased to the greatest amount tolerated. Patients will be followed through day 57 to assess durability of the intervention.

Sham vagus nerve stimulation

Device

Patients will receive transcutaneous stimulation of the vagus nerve for 5 minutes daily for 28 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes will be placed on the skin for stimulation. The electrical pulse generator is turned on and the amplitude of stimulation increased to the greatest amount tolerated, however, the vagus nerve will not be stimulated. Patients will be followed through day 57 to assess durability of the intervention.

Primary outcomes

  1. Change in Musculoskeletal Pain From Baseline.

    Time frame: 28 days

    Patients rate their musculoskeletal pain by making a mark on a 10cm anchored Visual Analog Scale where 0=no musculoskeletal pain and 10 =worst possible musculoskeletal pain.

Secondary outcomes

  1. Percentage of Subjects With Treatment Emergent Adverse Events.

    Time frame: 57 days

    The percentage of participants with grade 2 or higher or specific grade 1 treatment emergent adverse events will be assessed using the NCI-CTAEversion4.

    The percentage of participants with grade 2 or higher treatment emergent adverse events will be assessed using the NCI-CTAEversion4.

    The percentage of participants with grade 2 or higher treatment emergent adverse events will be assessed using the NCI-CTAEversion4.

  2. Change in Musculoskeletal Pain From Baseline

    Time frame: 5 days

    Patients rate their musculoskeletal pain by making a mark on a 10cm anchored Visual Analog Scale where 0=no musculoskeletal pain and 10 =worst possible musculoskeletal pain.

  3. Change in Musculoskeletal Pain From Baseline

    Time frame: 57 days

    Patients rate their musculoskeletal pain by making a mark on a 10cm anchored Visual Analog Scale where 0=no musculoskeletal pain and 10 =worst possible musculoskeletal pain.

  4. Change in Musculoskeletal Pain From Day 29 to Day 57

    Time frame: day 29 to day 57

    Patients rate their musculoskeletal pain by making a mark on a 10cm anchored Visual Analog Scale where 0=no musculoskeletal pain and 10 =worst possible musculoskeletal pain.

  5. Fatigue

    Time frame: 5 days

    Change from baseline fatigue will be measured using the FACIT F (Functional Assessment of Chronic Illness Therapy) questionnaire. The score ranges from 0 to 52, a higher score indicates less fatigue.

  6. Fatigue

    Time frame: 28 days

    Change from baseline fatigue will be measured using the FACIT F (Functional Assessment of Chronic Illness Therapy) questionnaire. The score ranges from 0 to 52, a higher score indicates less fatigue.

  7. Fatigue

    Time frame: 57 days

    Change from baseline fatigue will be measured using the FACIT F (Functional Assessment of Chronic Illness Therapy) questionnaire. The score ranges from 0 to 52, a higher score indicates less fatigue.

  8. Fatigue

    Time frame: day 29 to day 57

    Change from Day 29 fatigue to Day 57 will be measured using the FACIT F (Functional Assessment of Chronic Illness Therapy) questionnaire. The score ranges from 0 to 52, a higher score indicates less fatigue.

  9. Tender Joint Reduction

    Time frame: 5 days

    The percentage of tender joints reduced from baseline assessed by an investigator upon examining 68 potential tender joints.

  10. Tender Joint Reduction

    Time frame: 28 days

    The percentage of tender joints reduced from baseline assessed by an investigator upon examining 68 potential tender joints.

  11. Tender Joint Reduction

    Time frame: 57 days

    The percentage of tender joints reduced from baseline assessed by an investigator upon examining 68 potential tender joints.

  12. Tender Joint Reduction

    Time frame: Day 29 to Day 57

    The percentage of tender joints reduced from day 29 to day 57 will be assessed by an investigator upon examining 68 potential tender joints.

  13. Swollen joint reduction

    Time frame: 5 days

    The percentage of swollen joints reduced from baseline assessed by an investigator upon examining 66 potential swollen joints. Data shown for seven taVNS and five SS subjects with swollen joints at baseline.

  14. Swollen joint reduction

    Time frame: 28 days

    The percentage of swollen joints reduced from baseline assessed by an investigator upon examining 66 potential swollen joints. Data shown for seven taVNS and five SS subjects with swollen joints at baseline.

  15. Swollen joint reduction

    Time frame: 57 days

    The percentage of swollen joints reduced from baseline assessed by an investigator upon examining 66 potential swollen joints. Data shown for seven taVNS and five SS subjects with swollen joints at baseline.

  16. Swollen joint reduction

    Time frame: Day 29 to Day 57

    The percentage of swollen joints reduced from Day 29 to Day 57 assessed by an investigator upon examining 66 potential swollen joints. Data shown for seven taVNS and five SS subjects with swollen joints at baseline.

  17. Physician Global Assessment of Disease Activity (PGA)

    Time frame: Day 5

    Change in PGA from baseline, an anchored visual analog scale.ranging from 0 to 3 with higher scores signifying higher disease activity.

  18. Physician Global Assessment of Disease Activity (PGA)

    Time frame: Day 28

    Change in PGA from baseline, an anchored visual analog scale.ranging from 0 to 3 with higher scores signifying higher disease activity.

  19. Physician Global Assessment of Disease Activity (PGA)

    Time frame: Day 57

    Change in PGA from baseline, an anchored visual analog scale.ranging from 0 to 3 with higher scores signifying higher disease activity.

  20. Physician Global Assessment of Disease Activity (PGA)

    Time frame: Days 29 to 57

    Change in PGA from day 29 to day 57; PGA is an anchored visual analog scale.ranging from 0 to 3 with higher scores signifying higher disease activity.

  21. Patient Global Assessment of Disease (PtGA)

    Time frame: Day 5

    Change in PtGA from baseline, an anchored visual analog scale.ranging from 0 to 10 with higher scores signifying higher disease activity.

  22. Patient Global Assessment of Disease (PtGA)

    Time frame: Day 28

    Change in PtGA from baseline, an anchored visual analog scale.ranging from 0 to 10 with higher scores signifying higher disease activity.

  23. Patient Global Assessment of Disease (PtGA)

    Time frame: Day 57

    Change in PtGA from baseline, an anchored visual analog scale.ranging from 0 to 10 with higher scores signifying higher disease activity.

  24. Patient Global Assessment of Disease (PtGA)

    Time frame: Days 29 to 57

    Change in PtGA from day 29 to 57; PtGA is an anchored visual analog scale.ranging from 0 to 10 with higher scores signifying higher disease activity.

  25. Pain intensity

    Time frame: 5 days

    Pain intensity assessed by the PROMIS Pain Intensity Form 1a which asks subjects to mark a scale rating the average pain intensity over the past 7 days. The rating scale consists of whole numbers from 1 to 10. The PROMIS Pain Intensity Scale is a series of 3 questions that assess pain intensity at its worst, at its average, and at current moment. A higher score indicates higher levels of pain intensity.

  26. Pain intensity

    Time frame: 28 days

    Pain intensity assessed by the PROMIS Pain Intensity Form 1a which asks subjects to mark a scale rating the average pain intensity over the past 7 days. The rating scale consists of whole numbers from 1 to 10. The PROMIS Pain Intensity Scale is a series of 3 questions that assess pain intensity at its worst, at its average, and at current moment. A higher score indicates higher levels of pain intensity.

  27. Pain intensity

    Time frame: 57 days

    Pain intensity assessed by the PROMIS Pain Intensity Form 1a which asks subjects to mark a scale rating the average pain intensity over the past 7 days. The rating scale consists of whole numbers from 1 to 10. The PROMIS Pain Intensity Scale is a series of 3 questions that assess pain intensity at its worst, at its average, and at current moment. A higher score indicates higher levels of pain intensity.

  28. Pain intensity

    Time frame: Days 29 to 57

    Pain intensity assessed by the PROMIS Pain Intensity Form 1a which asks subjects to mark a scale rating the average pain intensity over the past 7 days. The rating scale consists of whole numbers from 1 to 10. The PROMIS Pain Intensity Scale is a series of 3 questions that assess pain intensity at its worst, at its average, and at current moment. A higher score indicates higher levels of pain intensity.

  29. Pain interference

    Time frame: 5 days

    Pain interference will be assessed by requesting subjects to answer the PROMIS Pain Interference Short Form 8a. The PROMIS Pain Interference Short Form 8a is a series of 8 questions which asks how much has pain interfered with different aspects of activities of daily living over the previous 7 days

  30. Pain interference

    Time frame: 28 days

    Pain interference will be assessed by requesting subjects to answer the PROMIS Pain Interference Short Form 8a. The PROMIS Pain Interference Short Form 8a is a series of 8 questions which asks how much has pain interfered with different aspects of activities of daily living over the previous 7 days

  31. Pain interference

    Time frame: 57 days

    Pain interference will be assessed by requesting subjects to answer the PROMIS Pain Interference Short Form 8a. The PROMIS Pain Interference Short Form 8a is a series of 8 questions which asks how much has pain interfered with different aspects of activities of daily living over the previous 7 days

  32. Pain interference

    Time frame: Days 29 to 57

    Pain interference will be assessed by requesting subjects to answer the PROMIS Pain Interference Short Form 8a. The PROMIS Pain Interference Short Form 8a is a series of 8 questions which asks how much has pain interfered with different aspects of activities of daily living over the previous 7 days

  33. Health Related Quality of Life (HRQoL))

    Time frame: 28 days

    HRQoL will be evaluated using the LupusQoL, a validated SLE specific index which assesses 8 domains including physical health, emotional health, body image, pain, planning, fatigue, intimate relationships, and burden to others. Higher scores correspond to worse quality-of-life.

  34. Health Related Quality of Life (HRQoL))

    Time frame: Day 57

    HRQoL will be evaluated using the LupusQoL, a validated SLE specific index which assesses 8 domains including physical health, emotional health, body image, pain, planning, fatigue, intimate relationships, and burden to others. Higher scores correspond to worse quality-of-life.

  35. Health Related Quality of Life (HRQoL))

    Time frame: Days 29 to 57

    HRQoL will be evaluated using the LupusQoL, a validated SLE specific index which assesses 8 domains including physical health, emotional health, body image, pain, planning, fatigue, intimate relationships, and burden to others. Higher scores correspond to worse quality-of-life.

  36. Anxiety

    Time frame: Day 29

    Promis Anxiety Short Form will assess anxiety. It is an 8 item questionaire assessing components related to anxiety including fear, anxious misery, hyperarousal, and somatic symptoms. Higher scores indicate greater levels of anxiety.

  37. Anxiety

    Time frame: Day 57

    Promis Anxiety Short Form will assess anxiety. It is an 8 item questionaire assessing components related to anxiety including fear, anxious misery, hyperarousal, and somatic symptoms. Higher scores indicate greater levels of anxiety.

  38. Anxiety

    Time frame: Days 29 to 57

    Promis Anxiety Short Form will assess anxiety. It is an 8 item questionaire assessing components related to anxiety including fear, anxious misery, hyperarousal, and somatic symptoms. Higher scores indicate greater levels of anxiety.

  39. Depression

    Time frame: Day 28

    Beck Depression Inventory (BDI) will assess depression. The BDI is a 21 item questionnaire measuring the severity of depression. Higher scores indicate greater levels of depression.

  40. Depression

    Time frame: Day 57

    Beck Depression Inventory (BDI) will assess depression. The BDI is a 21 item questionnaire measuring the severity of depression. Higher scores indicate greater levels of depression.

  41. Depression

    Time frame: Days 29 to 57

    Beck Depression Inventory (BDI) will assess depression. The BDI is a 21 item questionnaire measuring the severity of depression. Higher scores indicate greater levels of depression.

  42. Polysymptomatic distress

    Time frame: Day 29

    Polysymptomatic distress will be assessed by the Fibromyalgia Symptom Score (FSS), a patient reported outcome measuring the extent of polysymptomatic distress on a scale ranging from 0-31. Higher scores correspond to greater polysymptomatic distress.

  43. Polysymptomatic distress

    Time frame: Day 57

    Polysymptomatic distress will be assessed by the Fibromyalgia Symptom Score (FSS), a patient reported outcome measuring the extent of polysymptomatic distress on a scale ranging from 0-31. Higher scores correspond to greater polysymptomatic distress.

  44. Polysymptomatic distress

    Time frame: Days 29 to 57

    Polysymptomatic distress will be assessed by the Fibromyalgia Symptom Score (FSS), a patient reported outcome measuring the extent of polysymptomatic distress on a scale ranging from 0-31. Higher scores correspond to greater polysymptomatic distress.

  45. Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K)

    Time frame: Day 28

    SLEDAI-2K is a 24 item index which are scored by an investigator as either present or absent. Items include clinical and laboratory features of SLE. Higher scores correspond to greater disease activity.

  46. Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K)

    Time frame: Day 57

    SLEDAI-2K is a 24 item index which are scored by an investigator as either present or absent. Items include clinical and laboratory features of SLE. Higher scores correspond to greater disease activity.

  47. Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K)

    Time frame: Days 29 to 57

    SLEDAI-2K is a 24 item index which are scored by an investigator as either present or absent. Items include clinical and laboratory features of SLE. Higher scores correspond to greater disease activity.

  48. BILAG (British Isles Lupus Assessment Group) 2004

    Time frame: Day 28

    BILAG 2004 index assesses SLE disease activity in nine organ symptoms. Each domain is categorized into 1 of 5 levels (A, B, C, D, E). Lower letters (e.g. A) indicate more active disease.

  49. BILAG (British Isles Lupus Assessment Group) 2004

    Time frame: Day 57

    BILAG 2004 index assesses SLE disease activity in nine organ symptoms. Each domain is categorized into 1 of 5 levels (A, B, C, D, E). Lower letters (e.g. A) indicate more active disease.

  50. BILAG (British Isles Lupus Assessment Group) 2004

    Time frame: Days 29 to 57

    BILAG 2004 index assesses SLE disease activity in nine organ symptoms. Each domain is categorized into 1 of 5 levels (A, B, C, D, E). Lower letters (e.g. A) indicate more active disease.

  51. CLASI (Cutaneous LE Disease Area and Severity Index)

    Time frame: Day 28

    CLASI assesses SLE skin disease activity and damage. Higher scores indicate greater levels of cutaneous disease.

  52. CLASI (Cutaneous LE Disease Area and Severity Index)

    Time frame: Day 57

    CLASI assesses SLE skin disease activity and damage. Higher scores indicate greater levels of cutaneous disease.

  53. CLASI (Cutaneous LE Disease Area and Severity Index)

    Time frame: Days 29 to 57

    CLASI assesses SLE skin disease activity and damage. Higher scores indicate greater levels of cutaneous disease.

  54. Musculoskeletal disease activity--patient

    Time frame: Day 5

    Musculoskeletal disease activity will be assessed by patients by an anchored visual analog scale.ranging from 0 to 10 with higher scores signifying higher musculoskeletal disease activity.

  55. Musculoskeletal disease activity--patient

    Time frame: Day 29

    Musculoskeletal disease activity will be assessed by patients by an anchored visual analog scale.ranging from 0 to 10 with higher scores signifying higher musculoskeletal disease activity.

  56. Musculoskeletal disease activity--patient

    Time frame: Day 57

    Musculoskeletal disease activity will be assessed by patients by an anchored visual analog scale.ranging from 0 to 10 with higher scores signifying higher musculoskeletal disease activity.

  57. Musculoskeletal disease activity--patient

    Time frame: Days 29 to 57

    Musculoskeletal disease activity will be assessed by patients by an anchored visual analog scale.ranging from 0 to 10 with higher scores signifying higher musculoskeletal disease activity.

  58. Musculoskeletal disease activity--physician

    Time frame: Day 5

    Musculoskeletal disease activity will be assessed by the physician investigator by an anchored visual analog scale.ranging from 0 to 10 with higher scores signifying higher musculoskeletal disease activity.

  59. Musculoskeletal disease activity--physician

    Time frame: Day 28

    Musculoskeletal disease activity will be assessed by the physician investigator by an anchored visual analog scale.ranging from 0 to 10 with higher scores signifying higher musculoskeletal disease activity.

  60. Musculoskeletal disease activity--physician

    Time frame: Day 57

    Musculoskeletal disease activity will be assessed by the physician investigator by an anchored visual analog scale.ranging from 0 to 10 with higher scores signifying higher musculoskeletal disease activity.

  61. Musculoskeletal disease activity--physician

    Time frame: Days 28 to 57

    Musculoskeletal disease activity will be assessed by the physician investigator by an anchored visual analog scale.ranging from 0 to 10 with higher scores signifying higher musculoskeletal disease activity.

  62. Morning Stiffness

    Time frame: Day 5

    Morning stiffness will be assessed by patients by an anchored visual analog scale.ranging from 0 to 10 with higher scores signifying greater morning stiffness.

  63. Morning Stiffness

    Time frame: Day 28

    Morning stiffness will be assessed by patients by an anchored visual analog scale.ranging from 0 to 10 with higher scores signifying greater morning stiffness.

  64. Morning Stiffness

    Time frame: Day 57

    Morning stiffness will be assessed by patients by an anchored visual analog scale.ranging from 0 to 10 with higher scores signifying greater morning stiffness.

  65. Morning Stiffness

    Time frame: Days 29 to 57

    Morning stiffness will be assessed by patients by an anchored visual analog scale.ranging from 0 to 10 with higher scores signifying greater morning stiffness.

  66. Patient assessment of response

    Time frame: Day 5

    Patient assessment of response will be determined by a 5 component Likert scale by the patient.

  67. Patient assessment of response

    Time frame: Day 28

    Patient assessment of response will be determined by a 5 component Likert scale by the patient.

  68. Patient assessment of response

    Time frame: Day 57

    Patient assessment of response will be determined by a 5 component Likert scale by the patient.

  69. Physician assessment of response

    Time frame: Day 5

    Patient assessment of response will be determined by a 5 component Likert scale by the physician investigator.

  70. Physician assessment of response

    Time frame: Day 28

    Patient assessment of response will be determined by a 5 component Likert scale by the physician investigator.

  71. Physician assessment of response

    Time frame: Day 57

    Patient assessment of response will be determined by a 5 component Likert scale by the physician investigator.

  72. Lupus Low Disease Activity State (LLDAS)

    Time frame: Day 28

    LLDAS is a state achieved when there are minimal signs or symptoms of lupus disease activity while the patient is on low dose corticosteroids and stable therapy.

  73. Lupus Low Disease Activity State (LLDAS)

    Time frame: Day 57

    LLDAS is a state achieved when there are minimal signs or symptoms of lupus disease activity while the patient is on low dose corticosteroids and stable therapy.

  74. SRI-4

    Time frame: Day 28

    SRI-4 is a composite categorical response measure of improvement in SLE disease activity from a comparator timepoint/baseline. Achievement of the SRI-4 indicates a clinically meaningful response.

  75. SRI-4

    Time frame: Day 57

    SRI-4 is a composite categorical response measure of improvement in SLE disease activity from a comparator timepoint/baseline. Achievement of the SRI-4 indicates a clinically meaningful response.

Other outcomes

  1. Functional gut permeability

    Time frame: Day 28

    Functional gut permeability is assessed by measuring urinary C mannitol/lactulose ratios after oral injestion of the sugars, in timed urine collections over 24 hours.

  2. Stool microbiome

    Time frame: Day 28

    Stool microbiome is assessed by determining changes in metagenomics, metatranscriptomics and metabolomics from baseline in stool specimens.

  3. Gut permeability: serum I-FABP, zonulin and LPS, and by stool calprotectin and zonulin

    Time frame: Day 28

    Gut permeability: serum I-FABP is determined by measuring levels of serum I-FABP

  4. Gut permeability: zonulin

    Time frame: Day 28

    Gut permeability: zonulin is determined by measuring levels of serum zonulin

  5. Gut permeability: Lipopolysaccharide (LPS)

    Time frame: Day 28

    Gut permeability: Lipopolysaccharide (LPS) is determined by measuring levels of serum LPS.

  6. Gut permeability: Stool calprotectin

    Time frame: Day 28

    Gut permeability: Stool calprotectin is determined by measuring levels of calprotectin in the stool.

  7. Gut permeability: Stool zonulin

    Time frame: Day 28

    Gut permeability: Stool zonulin is determined by measuring levels of zonulin in the stool.

  8. Oxidative stress

    Time frame: Day 28

    Oxidative stress is determined by measuring levels of circulating glutathione and oxidized glutathione

  9. Oxidative stress

    Time frame: Day 57

    Oxidative stress is determined by measuring levels of circulating glutathione and oxidized glutathione

  10. Neurotrophins

    Time frame: Day 28

    Neurotrophins are determined by measuring circulating levels of neurotrophins (nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF).

  11. Neurotrophins

    Time frame: Day 57

    Neurotrophins are determined by measuring circulating levels of neurotrophins (nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF).

  12. Neurotrophins

    Time frame: Days 29 to 57

    Neurotrophins are determined by measuring circulating levels of neurotrophins (nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF).

  13. Kynurenine pathway metabolites

    Time frame: Day 28

    Kynurenine pathway metabolites are determined by measuring circulating levels of tryptophan, kynurenine, kynurenic acid and quinolinic acid

  14. Kynurenine pathway metabolites

    Time frame: Day 57

    Kynurenine pathway metabolites are determined by measuring circulating levels of tryptophan, kynurenine, kynurenic acid and quinolinic acid

  15. Kynurenine pathway metabolites

    Time frame: Days 28 to 57

    Kynurenine pathway metabolites are determined by measuring circulating levels of tryptophan, kynurenine, kynurenic acid and quinolinic acid

  16. Neuropeptides

    Time frame: Day 28

    Neuropeptides are determined by measuring circulating levels of substance P, calcitonin gene-related peptide (CGRP) and neuropeptide Y (NPY), neuropeptide B (NPB) and neuropeptide W (NPW).

  17. Neuropeptides

    Time frame: Day 57

    Neuropeptides are determined by measuring circulating levels of substance P, calcitonin gene-related peptide (CGRP) and neuropeptide Y (NPY), neuropeptide B (NPB) and neuropeptide W (NPW).

  18. Neuropeptides

    Time frame: Days 29 to 57

    Neuropeptides are determined by measuring circulating levels of substance P, calcitonin gene-related peptide (CGRP) and neuropeptide Y (NPY), neuropeptide B (NPB) and neuropeptide W (NPW).

  19. Erythrocyte Sedimentation Rate (ESR)

    Time frame: Day 5

    ESR is a laboratory parameter reflecting inflammation. It measures the rate that erythrocytes sediment (fall) over a specific period of time.

  20. Erythrocyte Sedimentation Rate (ESR)

    Time frame: Day 28

    ESR is a laboratory parameter reflecting inflammation. It measures the rate that erythrocytes sediment (fall) over a specific period of time.

  21. Erythrocyte Sedimentation Rate (ESR)

    Time frame: Day 57

    ESR is a laboratory parameter reflecting inflammation. It measures the rate that erythrocytes sediment (fall) over a specific period of time.

  22. Erythrocyte Sedimentation Rate (ESR)

    Time frame: Days 28 to 57

    ESR is a laboratory parameter reflecting inflammation. It measures the rate that erythrocytes sediment (fall) over a specific period of time.

  23. Complement component 3 (C3)

    Time frame: Day 28

    Serum levels of C3 are measured in a clinical laboratory

  24. Complement component 3 (C3)

    Time frame: Day 57

    Serum levels of C3 are measured in a clinical laboratory

  25. Complement component 3 (C3)

    Time frame: Days 28 to 57

    Serum levels of C3 are measured in a clinical laboratory

  26. Complement component 4 (C4)

    Time frame: Day 28

    Serum levels of C4 are measured in a clinical laboratory

  27. Complement component 4 (C4)

    Time frame: Day 57

    Serum levels of C4 are measured in a clinical laboratory

  28. Complement component 4 (C4)

    Time frame: Days 28 to 57

    Serum levels of C4 are measured in a clinical laboratory

  29. Anti-DNA antibodies

    Time frame: Day 28

    Serum levels of anti-DNA antibodies are measured by a laboratory

  30. Anti-DNA antibodies

    Time frame: Day 57

    Serum levels of anti-DNA antibodies are measured by a laboratory

  31. Anti-DNA antibodies

    Time frame: Days 28 to 57

    Serum levels of anti-DNA antibodies are measured by a laboratory

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Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Lupus Research Alliance

Registry information

Official study title

Transcutaneous Vagus Nerve Stimulation in SLE (TvSSLE)

Acronym: TvSSLE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 23, 2025
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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