Neuromodulation treatment for fibromyalgia and sleep disorders
Therapeutic Effect of Repetitive Transcranial Magnetic Stimulation on Sleep Disorders in Fibromyalgia Patients : A Double Blinded, Randomized Clinical Trial
This study is testing whether a special brain treatment can help people with fibromyalgia who also have trouble sleeping feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 20 Years to 50 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, ElGharbia) |
| Trial ID | NCT06373445 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of repetitive transcranial magnetic stimulation (rTMS) on fibromyalgia patients experiencing sleep disorders. A total of 40 eligible participants were randomized to receive either active or sham rTMS sessions over a four-week period, with evaluations conducted at baseline and follow-ups at one and three months post-treatment. The study aims to assess changes in fibromyalgia symptoms and sleep quality using standardized questionnaires and polysomnography. Conducted at Tanta and Assiut University hospitals, the trial adheres to rigorous inclusion and exclusion criteria to ensure participant safety and data integrity.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 50 with a diagnosis of fibromyalgia and sleep disorders who have not responded adequately to standard medical treatments.
Not a fit: Patients with inflammatory or autoimmune diseases, major sleep disorders, or contraindications to rTMS will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve sleep quality and reduce fibromyalgia symptoms in affected patients.
How similar studies have performed: While the approach of using rTMS for fibromyalgia is emerging, similar studies have shown promising results in improving symptoms, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 20 to 50 years. * Regular appropriate trial of medical treatment for at least 3 months. * Educated participants at least 12 years. Exclusion Criteria: * Inflammatory rheumatic disease, auto immune disease or other painful disorders. * Any uncontrolled clinical disease (such as thyroid, cardiovascular, pulmonary, hematological or renal disease) that affect the cognition. * pregnancy, lactation. * Contra indications for transcranial magnetic stimulation-a history of seizures, brain trauma, brain surgery or intracranial hypertension, a pace maker or other metallic implants. * Past history of major sleep disorders(narcolepsy, parasomnia or sleep apnea). * Illicit drug or alcohol abuse. * Inability to cooperate with the questionnaire survey.
Where this trial is running
Tanta, ElGharbia
- Faculty of medicine — Tanta, ElGharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Marwa Y Badr, MD neurology
- Email: drmoroneuro@yahoo.com
- Phone: 01003639125
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.