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| Name | Class |
|---|---|
| John and Marcia Goldman Foundation | UNKNOWN |
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Systemic Lupus Erythematosus (SLE) is a chronic autoimmune, inflammatory disease and musculoskeletal pain is one of the most common symptoms. This study will investigate whether transcutaneous stimulation of the vagus nerve will decrease lupus musculoskeletal pain. This study will additionally investigate the biologic effects of vagus nerve stimulation on inflammation. It will be the first clinical study using one of the body's own pathways of modulating the immune system and inflammatory response, the cholinergic anti-inflammatory pathway, in SLE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vagus Nerve Stimulation | Active Comparator | Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days. |
|
| Sham Vagus Nerve Stimulation | Sham Comparator | Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vagus nerve stimulation | Device | Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Musculoskeletal Pain From Baseline. | 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 days |
| Percentage of Subjects With Treatment Emergent Adverse Events. | The percentage of participants with grade 2 or higher treatment emergent adverse events will be assessed using the NCI-CTAEversion4. | 12 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Musculoskeletal Pain From Baseline | 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. | 12 days |
| Fatigue |
| Measure | Description | Time Frame |
|---|---|---|
| CRP | Change from baseline of CRP levels in patient serum. | 5 days |
| CRP | Change from baseline of CRP levels in patient serum. | 12 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Aranow, M.D. | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Feinstein Institute | Manhasset | New York | 11030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33687069 | Derived | Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2. |
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No subjects were excluded from the study before assignment to a treatment group.
Subjects were recruited from local clinics, word of mouth or from the ClinicalTrials.gov site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vagus Nerve Stimulation | Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days. Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch. |
| FG001 | Sham Vagus Nerve Stimulation | Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days. Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants with SLE with self-reported pain greater than or equal to 4 on a 10cm anchored VAS scale, and lupus related musculoskeletal activity were randomized 2:1 to receive 4 consecutive days of 5 minutes of vagus nerve stimulation or sham stimulation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vagus Nerve Stimulation | Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days. Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Musculoskeletal Pain From Baseline. | 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. | Posted | Median | Inter-Quartile Range | units on a scale | 5 days |
|
12 days
All adverse events with a severity greater than grade 1 are reported. The definition of an adverse event and/or serious adverse event used to collect adverse event information does not differ from that of clinicaltrials.gov. Other than the adverse event reported in the tables, no other adverse events were collected or reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vagus Nerve Stimulation | Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days. Vagus nerve stimulation: Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment | Grade 2 upper respiratory tract infection occurred in the context of the influenza season. No treatment given. Felt by investigator to be unrelated to the intervention. Adverse event resolved. |
This study was a short, small pilot study evaluating the effect of vagus nerve stimulation on pain and fatigue in SLE. Despite the dramatic clinical effects observed in this sham controlled trial, we were not able to fully identify the molecular pathway(s) engaged by vagus nerve stimulation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Aranow M.D. | Feinstein Institute for Medical Research | 516 562-3845 | caranow@northwell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 17, 2016 | Dec 1, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 31, 2018 | Dec 1, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D059352 | Musculoskeletal Pain |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D055536 | Vagus Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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|
| Sham vagus nerve stimulation | Device | Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve. |
|
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.
| 5 days |
| Fatigue | 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. | 12 days |
| Tender Joint Reduction | The percentage of tender joints reduced from baseline assessed by an investigator upon examining 68 potential tender joints. | 5 days |
| Tender Joint Reduction | The percentage of tender joints reduced from baseline assessed by an investigator upon examining 68 potential tender joints. | 12 days |
| Swollen Joint Count Reduction | 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. | 5 days |
| Swollen Joint Count Reduction | 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. | 12 days |
| Physician Global Assessment of Disease Activity (PGA) | Change in PGA from baseline, an anchored visual analog scale.ranging from 0 to 3 with higher scores signifying higher disease activity. | 5 days |
| Physician Global Assessment of Disease Activity (PGA) | Change in PGA from baseline, an anchored visual analog scale.ranging from 0 to 3 with higher scores signifying higher disease activity. | 12 days |
| Patient Global Assessment of Disease (PtGA) | Change in Patient Global Assessment of disease (PtGA) from baseline. This measure is a 10 cm visual analog scale (0-10); higher scores indicate a higher patient assessment of their disease activity. | 5 days |
| Patient Global Assessment of Disease (PtGA) | Change in Patient Global Assessment of disease (PtGA) from baseline. This measure is a 10 cm visual analog scale (0-10); higher scores indicate a higher patient assessment of their disease activity. | 12 days |
| IFNα | Change from baseline of IFNα levels an inflammatory cytokine in patient serum. | 5 days |
| IFNα | Change from baseline of IFNα levels an inflammatory cytokine in patient serum. | 12 days |
| Il-6 | Change from baseline of Il-6 levels in patient sera | 5 days |
| Il-6 | Change from baseline of Il-6 levels in patient sera. | 12 days |
| IL-1β | Change from baseline of levels of IL-1β, an inflammatory cytokine in patient serum. | 5 days |
| IL-1β | Change from baseline of levels of IL-1β, an inflammatory cytokine in patient serum. | 12 days |
| TNF | Change from baseline of TNF levels, an inflammatory cytokine in patient serum. | 5 days |
| TNF | Change from baseline of TNF levels, an inflammatory cytokine in patient serum. | 12 days |
| IL-10 | Change from baseline of IL-10 levels in patient serum. | 5 days |
| IL-10 | Change from baseline of IL-10 levels in patient serum. | 12 days |
| IL1-RA | Change from baseline of Il-1 RA levels in patient sera. | 5 days |
| IL-1 RA | Change from baseline of Il-1 RA levels in patient sera. | 12 days |
| Il-18 | Change from baseline of Il-18 levels in patient sera. | 5 days |
| Il-18 | Change from baseline of Il-18 levels in patient sera. | 12 days |
| IL-8 | Change from baseline of serum levels of IL-8 | 5 days |
| IL-8 | Change from baseline of serum levels of IL-8 | 12 days |
| Substance P | Change from baseline of plasma levels of substance P. | 5 days |
| Substance P | Change from baseline of plasma levels of substance P. | 12 days |
| Neuropeptide Y | Change from baseline of plasma levels of Neuropeptide Y. | 12 days |
| Neuropeptide Y | Change from baseline of plasma levels of Neuropeptide Y. | 5 days |
| Calcitonin Gene-Related Peptide (CGRP) | Change from baseline of plasma levels of CGRP. | 5 days |
| Calcitonin Gene-Related Peptide (CGRP) | Change from baseline of plasma levels of CGRP. | 12 days |
| Kynurenine | Change from baseline of serum levels of kynurenine | 5 days |
| Kynurenine | Change from baseline of serum levels of kynurenine | 12 days |
| Quinolinic Acid | Change from baseline of serum levels of quinolinic acid | 5 days |
| Quinolinic Acid | Change from baseline of serum levels of quinolinic acid | 12 days |
| Kynurenine/Tryptophan | Change from baseline of serum Kynurenine/Tryptophan | 5 days |
| Kynurenine/Tryptophan | Change from baseline of serum Kynurenine/Tryptophan | 12 days |
| BG001 | Sham Vagus Nerve Stimulation | Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days. Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Pain | Patient reported on a 10cm VAS | Mean | Standard Deviation | cm |
|
| Fatigue | FACIT-F, a validated Patient Reported Outcome to measure fatigue | Mean | Standard Deviation | units on a scale |
|
| Tender joints | Number of tender joints per subject | Mean | Standard Deviation | Tender joints per subject |
|
| Swollen joints | Number of swollen joints per subject | Mean | Standard Deviation | Swollen joints per subject |
|
| OG001 | Sham Vagus Nerve Stimulation | Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days. Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve. |
|
|
| Primary | Percentage of Subjects With Treatment Emergent Adverse Events. | The percentage of participants with grade 2 or higher treatment emergent adverse events will be assessed using the NCI-CTAEversion4. | Posted | Count of Participants | Participants | 12 days |
|
|
|
| Secondary | Change in Musculoskeletal Pain From Baseline | 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. | Posted | Median | Inter-Quartile Range | units on a scale | 12 days |
|
|
|
| Secondary | Fatigue | 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. | Posted | Median | Inter-Quartile Range | units on a scale | 5 days |
|
|
|
| Secondary | Fatigue | 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. | Posted | Median | Inter-Quartile Range | units on a scale | 12 days |
|
|
|
| Secondary | Tender Joint Reduction | The percentage of tender joints reduced from baseline assessed by an investigator upon examining 68 potential tender joints. | Posted | Median | Inter-Quartile Range | percentage of tender joints | 5 days |
|
|
|
| Secondary | Tender Joint Reduction | The percentage of tender joints reduced from baseline assessed by an investigator upon examining 68 potential tender joints. | Posted | Median | Inter-Quartile Range | percentage of tender joints | 12 days |
|
|
|
| Secondary | Swollen Joint Count Reduction | 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. | Posted | Median | Inter-Quartile Range | percentage of swollen joints reduced | 5 days |
|
|
|
| Secondary | Swollen Joint Count Reduction | 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. | Posted | Median | Inter-Quartile Range | percentage of swollen joints reduced | 12 days |
|
|
|
| Secondary | Physician Global Assessment of Disease Activity (PGA) | Change in PGA from baseline, an anchored visual analog scale.ranging from 0 to 3 with higher scores signifying higher disease activity. | Posted | Median | Inter-Quartile Range | units on a scale (0-3) | 5 days |
|
|
|
| Secondary | Physician Global Assessment of Disease Activity (PGA) | Change in PGA from baseline, an anchored visual analog scale.ranging from 0 to 3 with higher scores signifying higher disease activity. | Posted | Median | Inter-Quartile Range | units on a scale (0-3) | 12 days |
|
|
|
| Secondary | Patient Global Assessment of Disease (PtGA) | Change in Patient Global Assessment of disease (PtGA) from baseline. This measure is a 10 cm visual analog scale (0-10); higher scores indicate a higher patient assessment of their disease activity. | Posted | Median | Inter-Quartile Range | units on a scale (mm) | 5 days |
|
|
|
| Secondary | Patient Global Assessment of Disease (PtGA) | Change in Patient Global Assessment of disease (PtGA) from baseline. This measure is a 10 cm visual analog scale (0-10); higher scores indicate a higher patient assessment of their disease activity. | -(-to -) -(-to ) | Posted | Median | Inter-Quartile Range | units on a scale (mm) | 12 days |
|
|
|
| Other Pre-specified | CRP | Change from baseline of CRP levels in patient serum. | 0.00(0.00,) (-,-0.00) | Posted | Median | Inter-Quartile Range | mg/dL | 5 days |
|
|
|
| Other Pre-specified | CRP | Change from baseline of CRP levels in patient serum. | 0.00(- ,0.00) (-, | Posted | Median | Inter-Quartile Range | mg/dL | 12 days |
|
|
|
| Other Pre-specified | IFNα | Change from baseline of IFNα levels an inflammatory cytokine in patient serum. | Posted | Median | Inter-Quartile Range | pg/ml | 5 days |
|
|
|
| Other Pre-specified | IFNα | Change from baseline of IFNα levels an inflammatory cytokine in patient serum. | Posted | Median | Inter-Quartile Range | pg/ml | 12 days |
|
|
|
| Other Pre-specified | Il-6 | Change from baseline of Il-6 levels in patient sera | Posted | Median | Inter-Quartile Range | pg/ml | 5 days |
|
|
|
| Other Pre-specified | Il-6 | Change from baseline of Il-6 levels in patient sera. | Posted | Median | Inter-Quartile Range | pg/ml | 12 days |
|
|
|
| Other Pre-specified | IL-1β | Change from baseline of levels of IL-1β, an inflammatory cytokine in patient serum. | Posted | Median | Inter-Quartile Range | pg/ml | 5 days |
|
|
|
| Other Pre-specified | IL-1β | Change from baseline of levels of IL-1β, an inflammatory cytokine in patient serum. | Posted | Median | Inter-Quartile Range | pg/ml | 12 days |
|
|
|
| Other Pre-specified | TNF | Change from baseline of TNF levels, an inflammatory cytokine in patient serum. | Posted | Median | Inter-Quartile Range | pg/ml | 5 days |
|
|
|
| Other Pre-specified | TNF | Change from baseline of TNF levels, an inflammatory cytokine in patient serum. | Posted | Median | Inter-Quartile Range | pg/ml | 12 days |
|
|
|
| Other Pre-specified | IL-10 | Change from baseline of IL-10 levels in patient serum. | Posted | Median | Inter-Quartile Range | pg/ml | 5 days |
|
|
|
| Other Pre-specified | IL-10 | Change from baseline of IL-10 levels in patient serum. | Posted | Median | Inter-Quartile Range | pg/ml | 12 days |
|
|
|
| Other Pre-specified | IL1-RA | Change from baseline of Il-1 RA levels in patient sera. | Posted | Median | Inter-Quartile Range | pg/ml | 5 days |
|
|
|
| Other Pre-specified | IL-1 RA | Change from baseline of Il-1 RA levels in patient sera. | Posted | Median | Inter-Quartile Range | pg/ml | 12 days |
|
|
|
| Other Pre-specified | Il-18 | Change from baseline of Il-18 levels in patient sera. | Posted | Median | Inter-Quartile Range | pg/ml | 5 days |
|
|
|
| Other Pre-specified | Il-18 | Change from baseline of Il-18 levels in patient sera. | Posted | Median | Inter-Quartile Range | pg/ml | 12 days |
|
|
|
| Other Pre-specified | IL-8 | Change from baseline of serum levels of IL-8 | Posted | Median | Inter-Quartile Range | pg/ml | 5 days |
|
|
|
| Other Pre-specified | IL-8 | Change from baseline of serum levels of IL-8 | -(-to ) -(-to ) | Posted | Median | Inter-Quartile Range | pg/ml | 12 days |
|
|
|
| Other Pre-specified | Substance P | Change from baseline of plasma levels of substance P. | Posted | Median | Inter-Quartile Range | pg/ml | 5 days |
|
|
|
| Other Pre-specified | Substance P | Change from baseline of plasma levels of substance P. | Posted | Median | Inter-Quartile Range | pg/ml | 12 days |
|
|
|
| Other Pre-specified | Neuropeptide Y | Change from baseline of plasma levels of Neuropeptide Y. | Posted | Median | Inter-Quartile Range | pg/ml | 12 days |
|
|
|
| Other Pre-specified | Neuropeptide Y | Change from baseline of plasma levels of Neuropeptide Y. | Posted | Median | Inter-Quartile Range | pg/ml | 5 days |
|
|
|
| Other Pre-specified | Calcitonin Gene-Related Peptide (CGRP) | Change from baseline of plasma levels of CGRP. | Posted | Median | Inter-Quartile Range | pg/ml | 5 days |
|
|
|
| Other Pre-specified | Calcitonin Gene-Related Peptide (CGRP) | Change from baseline of plasma levels of CGRP. | Posted | Median | Inter-Quartile Range | pg/ml | 12 days |
|
|
|
| Other Pre-specified | Kynurenine | Change from baseline of serum levels of kynurenine | Posted | Median | Inter-Quartile Range | µM | 5 days |
|
|
|
| Other Pre-specified | Kynurenine | Change from baseline of serum levels of kynurenine | Posted | Median | Inter-Quartile Range | µM | 12 days |
|
|
|
| Other Pre-specified | Quinolinic Acid | Change from baseline of serum levels of quinolinic acid | Posted | Median | Inter-Quartile Range | nM | 5 days |
|
|
|
| Other Pre-specified | Quinolinic Acid | Change from baseline of serum levels of quinolinic acid | Posted | Median | Inter-Quartile Range | nM | 12 days |
|
|
|
| Other Pre-specified | Kynurenine/Tryptophan | Change from baseline of serum Kynurenine/Tryptophan | Posted | Median | Inter-Quartile Range | µM/µM | 5 days |
|
|
|
| Other Pre-specified | Kynurenine/Tryptophan | Change from baseline of serum Kynurenine/Tryptophan | -(-to ) (-to ) | Posted | Median | Inter-Quartile Range | µM/µM | 12 days |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 1 |
| 13 |
| EG001 | Sham Vagus Nerve Stimulation | Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days. Sham vagus nerve stimulation: Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve. | 0 | 6 | 0 | 6 | 0 | 6 |
|
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| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |