NCT02822989

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
1.3 years until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

6 months

First QC Date

May 26, 2016

Last Update Submit

September 8, 2020

Conditions

Lupus Erythematosus, SystemicMusculoskeletal Pain

Keywords

Lupus Erythematosus, SystemicMusculoskeletal PainInflammation

Outcome Measures

Primary Outcomes (1)

  • Musculoskeletal pain.

    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

Secondary Outcomes (9)

  • SLE Disease activity

    5 days

  • Fatigue

    5 days

  • Fatigue

    12 days

  • Tender and swollen joint counts

    5 days

  • Tender and swollen joint counts

    12 days

  • +4 more secondary outcomes

Other Outcomes (7)

  • TNF, HMGB1, IL-6, Il1B, IFNα and IL10 levels

    5 days

  • TNF, HMGB1, IL-6, Il1B, IFNα and IL10 levels

    12 days

  • Lipopolysaccharide stimulated levels of TNF, HMGB1, IL-6, Il1B, IFNα and IL10 in whole blood.

    5 days

  • +4 more other outcomes

Study Arms (2)

Vagus Nerve Stimulation

ACTIVE COMPARATOR

Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.

Device: Vagus nerve stimulation

Sham Vagus Nerve Stimulation

SHAM COMPARATOR

Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.

Device: Sham vagus nerve stimulation

Interventions

Vagus nerve stimulationDEVICE

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.

Vagus Nerve Stimulation
Sham vagus nerve stimulationDEVICE

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.

Sham Vagus Nerve Stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years,
  • SLE (defined by the ACR 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.

You may not qualify if:

  • Treatment with rituximab within one year of baseline (subjects with previous treatment with rituximab can enter study only with documentation of B cell repletion),
  • Treatment with cyclophosphamide within 2 months of baseline,
  • 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 (FSS).
  • Treatment with an anti-cholinergic medication, including over the counter medications,
  • Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.
  • Current tobacco or nicotine user,
  • 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,
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Feinstein Institute

Manhasset, New York, 11030, United States

Location

Related Publications (1)

  • 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.

    PMID: 33687069DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, SystemicMusculoskeletal PainInflammation

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesMuscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeutics

Study Officials

  • Cynthia Aranow, M.D.

    Northwell Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

May 26, 2016

First Posted

July 6, 2016

Study Start

November 1, 2017

Primary Completion

April 30, 2018

Study Completion

November 1, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)