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Vagus Nerve Stimulation for Fatigue in Systemic Lupus

NCT07256067 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-01

No results posted yet for this study

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

Interventions

DEVICE

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.

OTHER

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Research Ethical Committee, Faculty of Physical Therapy · faculty of physical therapy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2025-10-02
Completion
2025-11-02

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07256067 on ClinicalTrials.gov