Vagus Nerve Stimulation for Fatigue in Systemic Lupus

NCT ID: NCT07256067

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2025-11-02

Brief 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 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

Conditions

System Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental:Transcutanousvagus nerve stimulation plus aerobic exercise

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.

Group Type: EXPERIMENTAL

transcutaneous vagus nerve stimulation (tVNS)

Intervention Type: 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 exercise

sham transcutaneous vagus nerve stimulation (tVNS) using the same device and electrode placement. They will also perform the same 40-minute aerobic exercise program.

Group Type: SHAM_COMPARATOR

sham transcutaneous vagus nerve stimulation (tVNS) plus aerobic exercise

Intervention Type: OTHER

sham transcutaneous vagus nerve stimulation (tVNS) using the same device and electrode placement. They will also perform the same 40-minute aerobic exercise program.

Interventions

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.

Intervention Type: DEVICE

sham transcutaneous vagus nerve stimulation (tVNS) plus aerobic exercise

sham transcutaneous vagus nerve stimulation (tVNS) using the same device and electrode placement. They will also perform the same 40-minute aerobic exercise program.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Asmaa Saed Mahmoud Ebrahim

Teaching assistant in the Department of Surgery and Burns, Faculty of Physical Therapy, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Research Ethical Committee, Faculty of Physical Therapy

Role: PRINCIPAL_INVESTIGATOR

faculty of physical therapy

Locations

faculty of Physical Therapy

Giza, Egpt, Egypt

Countries

Egypt

Other Identifiers

2062021

Identifier Type: -

Identifier Source: org_study_id