Systemic Lupus ErythematosusVaNeSANCT05704153
Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A)
A study testing Parasym 1Hz and Parasym 30Hz in people with Systemic Lupus Erythematosus and Autoimmune Disorder, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The overall goal of this clinical trial is to evaluate the causality relationship between the non vagus nerve stimulation waveform parameters and the therapeutic effect. Thus, unlocking a pathway to optimize parameters that maximize the benefits of therapy and minimize unwanted side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus, Autoimmune Disorder, Vagus Nerve Autonomic Disorder
- What is being tested?
- Parasym 1Hz and Parasym 30Hz
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- 30 Sep 2022to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systemic lupus erythematosus (SLE) (defined by the American College of Rheumatology- or SLICC criteria)
- Musculoskeletal pain ≥ 4 on a non-anchored VAS 10 cm scale
- BILAG C on Musculoskeletal Domain of the BILAG 2004
- If on corticosteroids, the dose must be stable and ≤ 10mg/day (prednisone or equivalent) for at least 28 days before baseline,
- If on background immunosuppressive treatment the dose must be stable for at least 28 days before baseline
- Able and willing to give written informed consent and comply with the requirements of the study protocol.
Who cannot join
- Treatment with rituximab within one year of baseline as it is related to lymphocyte depletion that could alter the result of the biomarker study (subjects with previous treatment with rituximab can enter study only with documentation of B cell repletion).
- Treatment with cyclophosphamide within 2 months of baseline as it is related to lymphocyte depletion that could alter the result of the biomarker study.
- Expectation to increase steroids and/or immunosuppressive treatment.
- Anti-phospholipid syndrome.
- Fibromyalgia (fibromyalgia will be defined as a score > 13 on the Fibromyalgia Symptom Scale), chronic fatigue syndrome.
- Treatment with an anti-cholinergic or sympathicomimetic medication, including over the counter medications.
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- Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.
- Joint replacement within 60 days prior to study enrolment or planned within the course of the study.
- Any planned surgical procedure requiring general anaesthesia 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, hepatitis C or HIV at baseline due to high prevalence of neuropathy.
- Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention.
- Pregnancy or lactation.
- Haemoglobin below 9.0 gm/dL (by the most recent CBC) as anaemia is related to no- neurogenic orthostatic hypotension and increases cardiovascular symptoms in COMPASS 31 scale
- Comorbid disease that may require administration of corticosteroid use.
- Inability to comply with study and follow-up procedures.
- Known cardiac arrhythmia, severe cardiac disease or neurodegenerative disease.
- Known or confirmed at baseline screening peripheral or autonomic nervous system involvement, including LES-related, toxic polyneuropathies, metabolic neuropathies (including diabetes), etc.
- Previous experience with vagus nerve stimulation devices
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic
Barcelona, 08036
Judith Navarro, MD, 93 227 54 00
About this study
The overall goal of this clinical trial is to evaluate the causality relationship between the non vagus nerve stimulation waveform parameters and the therapeutic effect. Thus, unlocking a pathway to optimize parameters that maximize the benefits of therapy and minimize unwanted side effects. The experimental design includes the analysis of physiological signals, clinical biomarkers of disease, and clinical outcomes to determine the most effective measures for the monitoring, optimization, and personalization of non vagus nerve stimulation in systemic lupus erythematosus disease.
- Being tested
- Parasym 1Hz, Parasym 30Hz, Sham Intervention
- Keywords
- Parasympathetic Nervous System, Vagus Nerve Stimulation
- Medical subject headings
- Lupus Erythematosus, Systemic, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasym 1HzDevice
Transcutaneous auricular vagus nerve stimulation of 1Hz
Parasym 30HzDevice
Transcutaneous Auricular Vagus Nerve Stimulation of 30Hz
Sham InterventionDevice
Sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | Control group to be subjected to sham stimulation. Receives: Device: Sham Intervention |
| 30 hertz (Hz) Stimulation | Experimental | Group of patients treated via 30Hz transcutaneous electrical nerve stimulation Receives: Device: Parasym 30Hz |
| 1Hz Stimulation | Experimental | Group of patients treated via 1Hz transcutaneous electrical nerve stimulation Receives: Device: Parasym 1Hz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Systemic Lupus Erythematosus with clinical and analytic change after non-invasive vagus nerve stimulation (nVNS) at different waveform parameters
We will develop an nVNS platform with an integrated nVNS decision support system, including nVNS and physiological wearable sensors, that will optimize nVNS waveform parameters to maximize the therapeutic effect while minimizing unwanted side effects. Therapeutic effect and side effects will be measured by clinical, neurophysiological and analytic tests as described in "secondary outcome measures".
Measured: Visit 1(baseline, exploratory study, up to 30days prior to first nVNS)
Secondary outcomes (27)
Blood count
Complete blood count
Measured: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Erythrocyte sedimentation rate
Marker of inflammatory conditions, mm/h
Measured: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
C-reactive protein
Markers of inflammatory conditions, mg/dl
Measured: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Anti-dsDNA
Serological marker of activity in Systemic lupus erythematosus (SLE) ui/ml
Measured: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
C3, C4
Serological markers of activity in Systemic lupus erythematosus (SLE) g/l
Measured: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Tumoral necrosis factor (TNF), Interleukin (IL) -6, IL-10 and Il1B
Levels of pro-inflammatory cytokines, pg/ml
Measured: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
High mobility group box 1 protein (HMGB1)
Levels of pro-inflammatory cytokines, ui
Measured: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Alpha interferon (IFNα)
Ratios of IFNα protein, ui
Measured: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
EuroQol-5D (EQ-5D-5L),
EQ-5D-5L questionaries. Minimum 1, maximum 3, higher scores mean a worse outcome.
Measured: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels and 1 month after nVNS.
Lupus Patient-Reported Outcome (LupusPRO)
Lupus PRO questionaries. Minimum 0, maximum 5, higher scores mean a worse outcome.
Measured: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Lupus Quality of Life (LupusQoL)
Lupus QoL questionaries. Minimum 1, maximum 7, higher scores mean a worse outcome.
Measured: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
FACIT-F scale. Minimum 0, maximum 4, higher scores mean a worse outcome.
Measured: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Fatigue Severity Scale (FSS)
FSS. Minimum 1, maximum 7, higher scores mean a worse outcome.
Measured: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Composite Autonomic Symptom Score (Compass-31)
Self-scoring Compass 31 autonomic assessment. Minimum 0, maximum 100, higher scores mean a worse outcome.
Measured: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
28-joint count
28-joint count will be used to assess articular involvement.
Measured: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Physician's Global Assessment (PGA)
PGA as non-specific activity scale. Minimum 0, maximum 3, higher scores mean a worse outcome.
Measured: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Patients' Global Assessment (PtGA)
PtGA as non-specific activity scale. Minimum 0, maximum 100, higher scores mean a worse outcome.
Measured: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
CLASI will be used to evaluate skin involvement.Minimum 0, maximum 100, higher scores mean a worse outcome.
Measured: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Numeric scale ranges (NRS)
11-point NRS scale for pain. Minimum 0, maximum 10, higher scores mean a worse outcome.
Measured: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Visual Analog Scale (VAS)
VSA for pain. Minimum 0, maximum 10, higher scores mean a worse outcome.
Measured: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
High-frequency power, low-frequency power
Continuous electrocardiogram will be recorded at rest for 5 minutes for heart rate variability (HRV) analysis (high-frequency power HF, low-frequency power LF), m2
Measured: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
LF to HF power ratio
Continuous electrocardiogram will be recorded at rest for 5 minutes for heart rate variability (HRV) analysis ( LF to HF power ratio)
Measured: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Cardiovagal evaluation. (Composite autonomic scoring scale)
Continuous electrocardiogram heart rate changes during deep breathing and postural changes (beats per minute).Composite autonomic scoring scale minimun 0, maximum 3, higher scores mean a worse outcome.
Measured: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Vasalva ratio
Continuous electrocardiogram heart rate changes during Valsalva manoeuvre (ratio).
Measured: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Sympathetic evaluation (Composite autonomic scoring scale)
Beat-to-beat blood pressure changes to isometric exercise, Valsalva manoeuvre and postural changes, (mmHg). Composite autonomic scoring scale minimun 0, maximum 4, higher scores mean a worse outcome.
Measured: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Disease-specific activity scale. Minimum 0, maximum 105, higher scores mean a worse outcome.
Measured: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
BILAG-2004
Disease-specific activity scale. Minimum 0, maximum 32, higher scores mean a worse outcome.
Measured: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start30 Sep 2022
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- VaNeSA is a multicentre, national, randomized, double-blind, parallel-group, placebo-controlled, outpatient study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat de Girona, Hospital Mutua de Terrassa, Imperial College London, Johns Hopkins University
- Responsible party
- Principal investigator, Judith Navarro, MD PhD, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704153
- Sponsor's protocol ID
- PID2020-117171RA-I00-1A
- Acronym
- VaNeSA
- Status last verified
- Feb 2024
- First submitted
- 4 Oct 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Contreras I, Navarro-Otano J, Rodriguez-Pinto I, Guemes A, Alves E, Rios-Garces R, Espinosa G, Alejaldre A, Beneyto A, Ramkissoon CM, Vehi J, Cervera R. Optimizing Noninvasive Vagus Nerve Stimulation for Systemic Lupus Erythematosus: Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2023 Oct 13;12:e48387. doi: 10.2196/48387.
PubMed 37831494
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A)
- ClinicalTrials.gov ID
- NCT05704153
- Acronym / sponsor ID
- VaNeSA / PID2020-117171RA-I00-1A
- Keywords
- Parasympathetic Nervous System, Vagus Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Universitat de Girona, Hospital Mutua de Terrassa, Imperial College London, Johns Hopkins University
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this clinical trial is to evaluate the causality relationship between the non vagus nerve stimulation waveform parameters and the therapeutic effect. Thus, unlocking a pathway to optimize parameters that maximize the benefits of therapy and minimize unwanted side effects. The experimental design includes the analysis of physiological signals, clinical biomarkers of disease, and clinical outcomes to determine the most effective measures for the monitoring, optimization, and personalization of non vagus nerve stimulation in systemic lupus erythematosus disease.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- VaNeSA is a multicentre, national, randomized, double-blind, parallel-group, placebo-controlled, outpatient study.
| Arm | Type | Receives |
|---|---|---|
| Sham | Sham comparator | Device: Sham InterventionControl group to be subjected to sham stimulation. |
| 30 hertz (Hz) Stimulation | Experimental | Device: Parasym 30HzGroup of patients treated via 30Hz transcutaneous electrical nerve stimulation |
| 1Hz Stimulation | Experimental | Device: Parasym 1HzGroup of patients treated via 1Hz transcutaneous electrical nerve stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Systemic lupus erythematosus (SLE) (defined by the American College of Rheumatology- or SLICC criteria)
- Musculoskeletal pain ≥ 4 on a non-anchored VAS 10 cm scale
- BILAG C on Musculoskeletal Domain of the BILAG 2004
- If on corticosteroids, the dose must be stable and ≤ 10mg/day (prednisone or equivalent) for at least 28 days before baseline,
- If on background immunosuppressive treatment the dose must be stable for at least 28 days before baseline
Key exclusion criteria (21 listed)
- Treatment with rituximab within one year of baseline as it is related to lymphocyte depletion that could alter the result of the biomarker study (subjects with previous treatment with rituximab can enter study only with documentation of B cell repletion).
- Treatment with cyclophosphamide within 2 months of baseline as it is related to lymphocyte depletion that could alter the result of the biomarker study.
- Expectation to increase steroids and/or immunosuppressive treatment.
- Anti-phospholipid syndrome.
- Fibromyalgia (fibromyalgia will be defined as a score > 13 on the Fibromyalgia Symptom Scale), chronic fatigue syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parasym 1HzTranscutaneous auricular vagus nerve stimulation of 1Hz | Device | 1Hz Stimulation |
| Parasym 30HzTranscutaneous Auricular Vagus Nerve Stimulation of 30Hz | Device | 30 hertz (Hz) Stimulation |
| Sham InterventionSham stimulation | Device | Sham |
Primary outcome
Number of patients with Systemic Lupus Erythematosus with clinical and analytic change after non-invasive vagus nerve stimulation (nVNS) at different waveform parameters
Time frame: Visit 1(baseline, exploratory study, up to 30days prior to first nVNS)
We will develop an nVNS platform with an integrated nVNS decision support system, including nVNS and physiological wearable sensors, that will optimize nVNS waveform parameters to maximize the therapeutic effect while minimizing unwanted side effects. Therapeutic effect and side effects will be measured by clinical, neurophysiological and analytic tests as described in "secondary outcome measures".
27 secondary outcomes
Blood count
Time frame: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Erythrocyte sedimentation rate
Time frame: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
C-reactive protein
Time frame: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Anti-dsDNA
Time frame: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
C3, C4
Time frame: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Tumoral necrosis factor (TNF), Interleukin (IL) -6, IL-10 and Il1B
Time frame: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
High mobility group box 1 protein (HMGB1)
Time frame: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Alpha interferon (IFNα)
Time frame: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
EuroQol-5D (EQ-5D-5L),
Time frame: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels and 1 month after nVNS.
Lupus Patient-Reported Outcome (LupusPRO)
Time frame: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Lupus Quality of Life (LupusQoL)
Time frame: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Time frame: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Fatigue Severity Scale (FSS)
Time frame: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Composite Autonomic Symptom Score (Compass-31)
Time frame: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
28-joint count
Time frame: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Physician's Global Assessment (PGA)
Time frame: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Patients' Global Assessment (PtGA)
Time frame: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
Time frame: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Numeric scale ranges (NRS)
Time frame: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Visual Analog Scale (VAS)
Time frame: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
High-frequency power, low-frequency power
Time frame: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
LF to HF power ratio
Time frame: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Cardiovagal evaluation. (Composite autonomic scoring scale)
Time frame: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Vasalva ratio
Time frame: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Sympathetic evaluation (Composite autonomic scoring scale)
Time frame: Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Time frame: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
BILAG-2004
Time frame: Baseline, days 1-2-3-4-5 of nVNS, after five days of nVNS, after 2 weeks of nVNS, after3 weeks of nVSN. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 37831494Contreras I, Navarro-Otano J, Rodriguez-Pinto I, Guemes A, Alves E, Rios-Garces R, Espinosa G, Alejaldre A, Beneyto A, Ramkissoon CM, Vehi J, Cervera R. Optimizing Noninvasive Vagus Nerve Stimulation for Systemic Lupus Erythematosus: Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2023 Oct 13;12:e48387. doi: 10.2196/48387.
- Framework of the general project lead by Iván Contreras : VaNeSALink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parasym 1Hz and Parasym 30Hz in people with Systemic Lupus Erythematosus and Autoimmune Disorder, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Judith Navarro, MD (0034, JNAVARR1@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with Systemic Lupus Erythematosus with clinical and analytic change after non-invasive vagus nerve stimulation (nVNS) at different waveform parameters (time frame: Visit 1(baseline, exploratory study, up to 30days prior to first nVNS)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05704153, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.