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Behavioural Intervention

Vagus Nerve Stimulation for Systemic Lupus Erythematosus

N/A
Waitlist Available
Led By Cynthia Aranow, M.D.
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 days
Awards & highlights

Study 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.

Eligible Conditions
  • Systemic Lupus Erythematosus
  • Musculoskeletal Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Musculoskeletal pain.
Secondary outcome measures
Fatigue
Musculoskeletal Pain
Therapeutic procedure
+3 more
Other outcome measures
CpG stimulated levels of TNF, IL-6, Il1B, IFNα and IL10 in whole blood.
Interleukin-1
HMGB1 Protein
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Vagus Nerve StimulationActive Control1 Intervention
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Group II: Sham Vagus Nerve StimulationPlacebo Group1 Intervention
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,915 Total Patients Enrolled
John and Marcia Goldman FoundationUNKNOWN
Cynthia Aranow, M.D.Principal InvestigatorNorthwell Health
1 Previous Clinical Trials
43 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Using the Cholinergic Anti-Inflammatory Pathway to Treat Systemic Lupus Musculoskeletal Pain
Cynthia Aranow, MD 2017. "Using the Cholinergic Anti-Inflammatory Pathway to Treat Systemic Lupus Musculoskeletal Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02822989.
All > Lupus
~2 spots leftby Apr 2025
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