Ear stimulation device tested for lupus fatigue
NCT ID NCT07256067
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether a device that gently stimulates a nerve in the ear (vagus nerve) can reduce fatigue in women with lupus. Fifty women aged 35 to 55 took part. Half received the real stimulation plus aerobic exercise, while the other half received a sham device plus the same exercise. The goal was to see if the nerve stimulation could improve tiredness and walking ability.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- transcutaneous vagus nerve stimulation (tVNS) device
- What this could lead to
- If it works, this could offer a non-drug way to ease fatigue in people with lupus, improving daily life.
- What could go wrong
- This is a small, early-stage trial with only 50 participants. The results may not apply to everyone, and the effect might be small or due to the exercise alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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50 people
The number who actually took part.
- Started
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Aug 2025
- Finished
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Nov 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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35 to 55 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adults aged 35 to 55 years * Diagnosis of Systemic Lupus Erythematosus (SLE) based on the 2010 Revised American College of Rheumatology (ACR) or SLICC classification criteria. * Self-reported pain score of ≥4 on a 10 cm Visual Analogue Scale (VAS). * Receiving stable doses of Disease Modifying Anti-Rheumatic Drugs (DMARDs), biological therapy, and/or prednisone ≤10 mg/day, with no changes in dose within 28 days prior to baseline. * They have been referred by a rheumatologist. Exclusion Criteria: * Diagnosis of fibromyalgia or any other overlapping chronic pain syndrome. * Use of pacemakers, implantable cardioverter defibrillators (ICDs), or other electronic implants. * Current pregnancy or breastfeeding. * History of epilepsy or seizure disorders.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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faculty of Physical Therapy
Giza, Egpt, 12613, Egypt
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