Vagus nerve stimulation for treating fibromyalgia
Comparative Study Between the Outcome of Noninvasive Vagus Nerve Stimulation and Medical Treatment in Fibromyalgia Patients
This study tests if a new treatment using vagus nerve stimulation can help women with fibromyalgia feel better compared to standard medical care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Kasr El Aini Hospital Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06237595 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of transcutaneous cervical vagus nerve stimulation (t-VNS) on female patients diagnosed with fibromyalgia. Ninety participants will be divided into three groups: one receiving only t-VNS, another receiving t-VNS along with standard medical treatment, and a control group receiving only medical treatment. The t-VNS sessions will be conducted three times a week for a total of 12 sessions, aiming to assess improvements in symptoms compared to conventional therapies.
Who should consider this trial
Good fit: Ideal candidates are female patients over 18 years old with a clinical diagnosis of fibromyalgia according to the 2016 ACR criteria.
Not a fit: Patients with significant comorbid medical or psychiatric conditions, or those who are pregnant or postmenopausal, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for fibromyalgia patients, potentially reducing symptoms and improving quality of life.
How similar studies have performed: While vagus nerve stimulation has shown promise in other conditions, this specific application in fibromyalgia is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients above 18 years, with a clinical diagnosis of fibromyalgia according to 2016 ACR fibromyalgia diagnostic criteria, will be included in this study. Exclusion Criteria: * - Pregnant, and postmenopausal women. * Patients with any medical disorder including: cardiovascular, pulmonary, renal, hepatic, endocrine, blood, gastrointestinal, diabetes, neuropathic disorders, psychiatric disorders (for example; post traumatic stress disorder (PTSD), mania, psychosis, suicidality, bipolar/schizophrenia/autism spectrum disorders) and/or neurodegenerative disorders (e.g., Parkinson's, Alzheimer's, Huntington's disease). * Cancer diagnosis within the preceding 5 years. * Planned surgery. * Use of other medical devices electrically active for example a cardiac pacemaker, or TENS for chronic pain. * Electrocardiogram (ECG) abnormalities. * History of Electroconvulsive therapy (ECT). * Symptomatic orthostatic hypotension, or history of recurrent vagal syncope. * History of vagotomy. * Uncontrolled hypertension or hypotension. * Documented sleep apnea. * Other rheumatic diseases like (Rheumatoid Arthritis, Systemic lupus erythematosus, Seronegative spondyloarthropathies).
Where this trial is running
Cairo
- Kasr Elainy Hospital — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Hadeel A Elegily, DR — kasr Elainy Hospital
- Study coordinator: Hadeel A Elegily, dr
- Email: hadilalielegily@gmail.com
- Phone: 00201066496611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.