Vagus Nerve Stimulation for Fatigue in Systemic Lupus

NCT07256067 | Completed DMC

• 1 other identifier: 2062021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

System Lupus Erythematosus

Keywords

Vagus Nerve Stimulation; Fatigue; Lupus

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (2)

• Six-Minute Walk Test (6MWT) andBorg Rating of Perceived Exertion (RPE) (Borg Test)

  6 weeks

• Borg rating scale

  6 weeks

Study Arms (2)

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.

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.

Other: sham transcutaneous vagus nerve stimulation (tVNS) plus aerobic exercise

Interventions

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.

Experimental:Transcutanousvagus nerve stimulation plus aerobic exercise

sham transcutaneous vagus nerve stimulation (tVNS) plus aerobic exercise 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.

sham transcutaneous vagus nerve stimulation (tVNS) plus aerobic exercise

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of Physical Therapy

Giza, Egpt, 12613, Egypt

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Fatigue

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Research Ethical Committee, Faculty of Physical Therapy

  faculty of physical therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant in the Department of Surgery and Burns, Faculty of Physical Therapy, Cairo University

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: December 1, 2025
• Study Start: August 1, 2025
• Primary Completion: October 2, 2025
• Study Completion: November 2, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

EG (1)