Modulating brain activity to reduce pain in fibromyalgia
Cortical Excitability Modulation With Cerebellar Transcranial Direct Current Stimulation in Fibromyalgia: a Randomized Clinical Trial
This study is testing if a brain stimulation technique can help people with fibromyalgia feel less pain and improve their overall symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Hospital de Clinicas de Porto Alegre Academic / other |
| Locations | 2 sites (Porto Alegre, Rio Grande Do Sul and 1 other locations) |
| Trial ID | NCT05963321 on ClinicalTrials.gov |
What this trial studies
This research evaluates the effects of cerebellar transcranial direct current stimulation (tDCS) on pain and cortical excitability in patients diagnosed with fibromyalgia. The study involves a single session of tDCS aimed at modulating neuronal activity to alleviate chronic pain symptoms associated with this condition. Additionally, transcranial magnetic stimulation (TMS) is utilized to gain insights into the underlying pathophysiology of fibromyalgia. The goal is to explore new therapeutic options for patients who have limited responses to traditional pharmacological treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are right-handed women aged 18 to 65 with a confirmed diagnosis of fibromyalgia and a pain score of 4 or higher on the Numerical Pain Scale.
Not a fit: Patients with contraindications to TMS and tDCS, such as those with metallic implants or certain neurological conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel non-invasive treatment option for managing chronic pain in fibromyalgia patients.
How similar studies have performed: Previous studies using non-invasive brain stimulation techniques like tDCS and TMS have shown promising results in reducing pain, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Right-handed women aged 18 to 65 years; who can read and write * Confirmed diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology (2010-2016). * Pain score equal to or greater than 4 on the Numerical Pain Scale (Score 0-10) on most days in the last 3 months. Exclusion Criteria: * Reside outside Porto Alegre area. * Confirmed pregnancy * Contraindications to TMS and tDCS: metallic implant in the brain; medical devices implanted in the brain, heart pacemaker; cochlear implant; history of alcohol or drug abuse in the last 6 months; neurological pathologies; hx of head trauma or neurosurgery; decompensated systemic diseases and chronic inflammatory diseases (lupus, rheumatoid arthritis, Reiter's syndrome); uncompensated hypothyroidism; personal history of cancer, past or undergoing treatment. * Participants with diagnosis or recent contact with COVID will be excluded.
Where this trial is running
Porto Alegre, Rio Grande Do Sul and 1 other locations
- Hospital de Clinicas de Porto Alegre — Porto Alegre, Rio Grande Do Sul, Brazil (Recruiting)
- Hospital de clinicas de Porto Alegre — Porto Alegre, Rio Grande Do Sul, Brazil (Recruiting)
Study contacts
- Study coordinator: Wolnei Caumo, PhD
- Email: wcaumo@hcpa.edu.br
- Phone: 55 51 33596377
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.