System Lupus ErythematosusNCT07256067
Vagus Nerve Stimulation for Fatigue in Systemic Lupus
A study testing transcutaneous vagus nerve stimulation (tVNS) in people with System Lupus Erythematosus, run by Cairo University at 1 site in Egypt.
Trial summary
50female patients diagnosed with systemic lupus erythematosus according to the 2010 Revised American College of Rheumatology (ACR). Their age will range from 35 to 55 years. The participants will be selected from one major healthcare institutions: Al Kaser Al Ayni Teaching hospital, will be randomly equally… Read more about this study
- Who is it for?
- Ages 35 to 55 years, women only
- Conditions the study is for
- System Lupus Erythematosus
- What is being tested?
- transcutaneous vagus nerve stimulation (tVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 2 Nov 2025
- 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 35 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Vagus Nerve Acupoint Transcutaneous Electrical Nerve Stimulation on Fatigue in Patients With Systemic Lupus Erythematosus: A Randomized Controlled Trial
50female patients diagnosed with systemic lupus erythematosus according to the 2010 Revised American College of Rheumatology (ACR). Their age will range from 35 to 55 years. The participants will be selected from one major healthcare institutions: Al Kaser Al Ayni Teaching hospital, will be randomly equally distributed into two groups.
Group A :(Treatment Group):
Read more
This group includes 25 patients diagnosed with systemic lupus erythematosus according to the 2010 Revised American College of Rheumatology (ACR),and will receive transcutaneous vagus nerve stimulation (tVNS), combined with aerobic exercise alongside medical treatment. Patients will receive 3 sessions per week for 6 weeks, the time of session is 45 - 60 min according to patient ability.
Group B :( Control Group) This group includes 25 patients diagnosed with systemic lupus erythematosus according to the 2010 Revised American College of Rheumatology (ACR)and will receive sham transcutaneous vagus nerve stimulation (tVNS) using the same device and electrode placement. They will also perform the same 40-minute aerobic exercise program alongside medical treatment. Patients will receive 3 sessions per week for 6 weeks.
Read the detailed description
1)Subjects: 50female patients diagnosed with systemic lupus erythematosus according to the 2010 Revised American College of Rheumatology (ACR). Their age will range from 35 to 55 years. The participants will be selected from one major healthcare institutions: Al Kaser Al Ayni Teaching hospital, will be randomly equally distributed into two groups.
Group A :(Treatment Group):
This group includes 25 patients diagnosed with systemic lupus erythematosus according to the 2010 Revised American College of Rheumatology (ACR),and will receive transcutaneous vagus nerve stimulation (tVNS), combined with aerobic exercise alongside medical treatment. Patients will receive 3 sessions per week for 6 weeks, the time of session is 45 - 60 min according to patient ability.
Group B :( Control Group) This group includes 25 patients diagnosed with systemic lupus erythematosus according to the 2010 Revised American College of Rheumatology (ACR)and will receive sham transcutaneous vagus nerve stimulation (tVNS) using the same device and electrode placement. They will also perform the same 40-minute aerobic exercise program alongside medical treatment. Patients will receive 3 sessions per week for 6 weeks.
2)Equipment:
- Therapeutic Equipment: .Transcutaneous auricular vagus nerve stimulation (taVNS) was administered exclusively with fixed stimulation parameters set at a frequency of 30 Hz and a pulse width of 300 μs.
- Only spring-loaded clip electrodes were used for stimulation on the left ear.
- an aerobic exercises designed to improve mobility, strength, and fatigue tolerance lasted 40 minutes and included treadmill, walking andcycling with moderate intensity (60-70% max HR and frequency 3 sessions per week
- No additional therapies (e.g., resistance training, aquatic therapy, or medications) were included in the intervention.
Measurement equipment:
- Fatigue severity scale: is a widely used self-report questionnaire designed to assess the impact of fatigue on daily functioning. It consists of nine statements rated on a 7-point Likert scale, with higher scores indicating greater fatigue severity. The FSS has demonstrated strong psychometric properties in patients with systemic lupus erythematosus (SLE), including excellent internal consistency (Cronbach's α > 0.90) and good test-retest reliability (ICC = 0.84-0.89). The Arabic version of the FSS has been validated in multiple studies and has shown comparable reliability and construct validity to the original version. For example, Al-Sobayel et al. (2016) reported a Cronbach's α of 0.93 for the Arabic FSS in a population of Arabic-speaking patients with chronic diseases, including SLE. This makes the Arabic FSS a culturally appropriate and psychometrically sound instrument for assessing fatigue in Arabic-speaking populations.
Six-Minute Walk Test (6MWT) is a sub-maximal exercise test that measures the distance a person can walk as far as possible in six minutes along a flat, hard surface.
It is used to assess functional exercise capacity, endurance, and the integrated global response of many systems: pulmonary and cardiac function, circulation, peripheral circulation, neuromuscular function, The test can show performance fatigability when there is a decline in the individual's walking speed or distance over time (for instance, comparing the first minute of walking vs the last minute.
Borg Rating of Perceived Exertion (RPE) ("Borg Test") is a subjective scale developed by Gunnar Borg, used to gauge how hard someone feels they are working during physical activity. It captures feelings of exertion, breathlessness, muscle fatigue, heart rate
- Conditions
- System Lupus Erythematosus
- Being tested
- transcutaneous vagus nerve stimulation (tVNS), sham transcutaneous vagus nerve stimulation (tVNS) plus aerobic exercise
- Keywords
- Vagus Nerve Stimulation, Fatigue, Lupus
- Medical subject headings
- Lupus Erythematosus, Systemic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous vagus nerve stimulation (tVNS)Device
Transcutaneous auricular vagus nerve stimulation (taVNS) was administered exclusively with fixed stimulation parameters set at a frequency of 30 Hz and a pulse width of 300 μs.3times a week for 6 week.
- Only spring-loaded clip electrodes were used for stimulation on the left ear.
- an aerobic exercises designed to improve mobility, strength, and fatigue tolerance lasted 40 minutes and included treadmill, walking andcycling with moderate intensity (60-70% max HR and frequency 3 sessions per week
- No additional therapies (e.g., resistance training, aquatic therapy, or medications) were included in the intervention.
sham transcutaneous vagus nerve stimulation (tVNS) plus aerobic exerciseOther
sham transcutaneous vagus nerve stimulation (tVNS) using the same device and electrode placement. They will also perform the same 40-minute aerobic exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Experimental:Transcutanousvagus nerve stimulation plus aerobic exercise | Experimental | Transcutaneous vagus nerve stimulation (tVNS), combined with aerobic exercise. Stimulation will be applied to the left auricular concha for 20 minutes per session, three times per week for six weeks, using standardized settings (30 Hz frequency, 300 μs pulse width) at a tolerable, non-painful intensity. This will be followed by 40 minutes of aerobic exercises. Receives: Device: transcutaneous vagus nerve stimulation (tVNS) |
| sham transcutaneous vagus nerve stimulation (tVNS) plus aerobic exercise | Sham comparator | sham transcutaneous vagus nerve stimulation (tVNS) using the same device and electrode placement. They will also perform the same 40-minute aerobic exercise program. Receives: Other: sham transcutaneous vagus nerve stimulation (tVNS) plus aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue severity scale
The Fatigue Severity Scale (FSS) is a widely used self-report questionnaire designed to assess the impact of fatigue on daily functioning. It consists of nine statements rated on a 7-point Likert scale, with higher scores indicating greater fatigue severity. The FSS has demonstrated strong psychometric properties in patients with systemic lupus erythematosus (SLE), including excellent internal consistency (Cronbach's α > 0.90) and good test-retest reliability (ICC = 0.84-0.89). The Arabic version of the FSS has been validated in multiple studies and has shown comparable reliability and construct validity to the original version.
Measured: 6 weeks
Secondary outcomes (2)
Six-Minute Walk Test (6MWT) andBorg Rating of Perceived Exertion (RPE) (Borg Test)
The 6MWT is a sub-maximal exercise test that measures the distance a person can walk as far as possible in six minutes along a flat, hard surface.
It is used to assess functional exercise capacity, endurance, and the integrated global response of many systems: pulmonary and cardiac function, circulation, peripheral circulation, neuromuscular function, The test can show performance fatigability when there is a decline in the individual's walking speed or distance over time (for instance, comparing the first minute of walking vs the last minute. That was measured by map by walk phone application.
Measured: 6 weeks
Borg rating scale
RPE is a subjective scale developed by Gunnar Borg, used to gauge how hard someone feels they are working during physical activity. It captures feelings of exertion, breathlessness, muscle fatigue, heart rate
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start1 Aug 2025
- Primary completion2 Oct 2025
- Study completion2 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for System Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Saed Mahmoud Ebrahim, Cairo University
- Investigators
- Research Ethical Committee, Faculty of Physical Therapy, Principal investigator, faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256067
- Sponsor's protocol ID
- 2062021
- Status last verified
- Nov 2025
- First submitted
- 29 Sep 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vagus Nerve Acupoint Transcutaneous Electrical Nerve Stimulation on Fatigue in Patients With Systemic Lupus Erythematosus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07256067
- Acronym / sponsor ID
- 2062021
- Conditions
- System Lupus Erythematosus
- Keywords
- Vagus Nerve Stimulation, Fatigue, Lupus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 2 Nov 2025 (actual)
- First posted
- 1 Dec 2025 (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.
50female patients diagnosed with systemic lupus erythematosus according to the 2010 Revised American College of Rheumatology (ACR). Their age will range from 35 to 55 years. The participants will be selected from one major healthcare institutions: Al Kaser Al Ayni Teaching hospital, will be randomly equally distributed into two groups.
Group A :(Treatment Group):
This group includes 25 patients diagnosed with systemic lupus erythematosus according to the 2010 Revised American College of Rheumatology (ACR),and will receive transcutaneous vagus nerve stimulation (tVNS), combined with aerobic exercise alongside medical treatment. Patients will receive 3 sessions per week for 6 weeks, the time of session is 45 - 60 min according to patient ability.
Group B :( Control Group) This group includes 25 patients diagnosed with systemic lupus erythematosus according to the 2010 Revised American College of Rheumatology (ACR)and will receive sham transcutaneous vagus nerve stimulation (tVNS) using the same device and electrode placement. They will also perform the same 40-minute aerobic exercise program alongside medical treatment. Patients will receive 3 sessions per week for 6 weeks.
Detailed description
1)Subjects: 50female patients diagnosed with systemic lupus erythematosus according to the 2010 Revised American College of Rheumatology (ACR). Their age will range from 35 to 55 years. The participants will be selected from one major healthcare institutions: Al Kaser Al Ayni Teaching hospital, will be randomly equally distributed into two groups.
Group A :(Treatment Group):
This group includes 25 patients diagnosed with systemic lupus erythematosus according to the 2010 Revised American College of Rheumatology (ACR),and will receive transcutaneous vagus nerve stimulation (tVNS), combined with aerobic exercise alongside medical treatment. Patients will receive 3 sessions per week for 6 weeks, the time of session is 45 - 60 min according to patient ability.
Group B :( Control Group) This group includes 25 patients diagnosed with systemic lupus erythematosus according to the 2010 Revised American College of Rheumatology (ACR)and will receive sham transcutaneous vagus nerve stimulation (tVNS) using the same device and electrode placement. They will also perform the same 40-minute aerobic exercise program alongside medical treatment. Patients will receive 3 sessions per week for 6 weeks.
2)Equipment:
- Therapeutic Equipment: .Transcutaneous auricular vagus nerve stimulation (taVNS) was administered exclusively with fixed stimulation parameters set at a frequency of 30 Hz and a pulse width of 300 μs.
- Only spring-loaded clip electrodes were used for stimulation on the left ear.
- an aerobic exercises designed to improve mobility, strength, and fatigue tolerance lasted 40 minutes and included treadmill, walking andcycling with moderate intensity (60-70% max HR and frequency 3 sessions per week
- No additional therapies (e.g., resistance training, aquatic therapy, or medications) were included in the intervention.
Measurement equipment:
- Fatigue severity scale: is a widely used self-report questionnaire designed to assess the impact of fatigue on daily functioning. It consists of nine statements rated on a 7-point Likert scale, with higher scores indicating greater fatigue severity. The FSS has demonstrated strong psychometric properties in patients with systemic lupus erythematosus (SLE), including excellent internal consistency (Cronbach's α > 0.90) and good test-retest reliability (ICC = 0.84-0.89). The Arabic version of the FSS has been validated in multiple studies and has shown comparable reliability and construct validity to the original version. For example, Al-Sobayel et al. (2016) reported a Cronbach's α of 0.93 for the Arabic FSS in a population of Arabic-speaking patients with chronic diseases, including SLE. This makes the Arabic FSS a culturally appropriate and psychometrically sound instrument for assessing fatigue in Arabic-speaking populations.
Six-Minute Walk Test (6MWT) is a sub-maximal exercise test that measures the distance a person can walk as far as possible in six minutes along a flat, hard surface.
It is used to assess functional exercise capacity, endurance, and the integrated global response of many systems: pulmonary and cardiac function, circulation, peripheral circulation, neuromuscular function, The test can show performance fatigability when there is a decline in the individual's walking speed or distance over time (for instance, comparing the first minute of walking vs the last minute.
Borg Rating of Perceived Exertion (RPE) ("Borg Test") is a subjective scale developed by Gunnar Borg, used to gauge how hard someone feels they are working during physical activity. It captures feelings of exertion, breathlessness, muscle fatigue, heart rate
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental:Transcutanousvagus nerve stimulation plus aerobic exercise | Experimental | Device: transcutaneous vagus nerve stimulation (tVNS)Transcutaneous vagus nerve stimulation (tVNS), combined with aerobic exercise. Stimulation will be applied to the left auricular concha for 20 minutes per session, three times per week for six weeks, using standardized settings (30 Hz frequency, 300 μs pulse width) at a tolerable, non-painful intensity. This will be followed by 40 minutes of aerobic exercises. |
| sham transcutaneous vagus nerve stimulation (tVNS) plus aerobic exercise | Sham comparator | Other: sham transcutaneous vagus nerve stimulation (tVNS) plus aerobic exercisesham transcutaneous vagus nerve stimulation (tVNS) using the same device and electrode placement. They will also perform the same 40-minute aerobic exercise program. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| transcutaneous vagus nerve stimulation (tVNS)Transcutaneous auricular vagus nerve stimulation (taVNS) was administered exclusively with fixed stimulation parameters set at a frequency of 30 Hz and a pulse width of 300 μs.3times a week for 6 week. * Only spring-loaded clip electrodes were used for stimulation on the left ear. * an aerobic exercises designed to improve mobility, strength, and fatigue tolerance lasted 40 minutes and included treadmill, walking andcycling with moderate intensity (60-70% max HR and frequency 3 sessions per week * No additional therapies (e.g., resistance training, aquatic therapy, or medications) were included in the intervention. | Device | Experimental:Transcutanousvagus nerve stimulation plus aerobic exercise |
| sham transcutaneous vagus nerve stimulation (tVNS) plus aerobic exercisesham transcutaneous vagus nerve stimulation (tVNS) using the same device and electrode placement. They will also perform the same 40-minute aerobic exercise program. | Other | sham transcutaneous vagus nerve stimulation (tVNS) plus aerobic exercise |
Primary outcome
Fatigue severity scale
Time frame: 6 weeks
The Fatigue Severity Scale (FSS) is a widely used self-report questionnaire designed to assess the impact of fatigue on daily functioning. It consists of nine statements rated on a 7-point Likert scale, with higher scores indicating greater fatigue severity. The FSS has demonstrated strong psychometric properties in patients with systemic lupus erythematosus (SLE), including excellent internal consistency (Cronbach's α > 0.90) and good test-retest reliability (ICC = 0.84-0.89). The Arabic version of the FSS has been validated in multiple studies and has shown comparable reliability and construct validity to the original version.
2 secondary outcomes
Six-Minute Walk Test (6MWT) andBorg Rating of Perceived Exertion (RPE) (Borg Test)
Time frame: 6 weeks
Borg rating scale
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
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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.
Research Ethical Committee, Faculty of Physical Therapy principal investigator
faculty of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous vagus nerve stimulation (tVNS) in people with System Lupus Erythematosus, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 1 Dec 2025. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue severity scale (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2025.