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NCT03843203
Long Term Home Based tDCS in Fibromyalgia
NA trial testing Transcranial Direct Current Stimulation - tDCS in Fibromyalgia in 84 participants. Status unknown.
1 January 2020
Quick facts
| Lead sponsor | Hospital de Clinicas de Porto Alegre |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 84 |
| Start date | 1 June 2018 |
| Primary completion | 1 January 2020 |
| Estimated completion | 1 January 2021 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Transcranial Direct Current Stimulation - tDCS
Conditions studied
- Fibromyalgia — all drugs for Fibromyalgia →
- Transcranial Direct Current Stimulation — all drugs for Transcranial Direct Current Stimulation →
Sponsor
Hospital de Clinicas de Porto Alegre
Who can join
Adults 30 to 65, female only, with Fibromyalgia or Transcranial Direct Current Stimulation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Fibromyalgia(FM) is a widespread musculoskeletal pain syndrome characterized by fatigue, sleep disorders, cognitive impairment, depressive symptoms and neuro-vegetative symptoms. It is a multivariable and complex neurobiological process. FM worldwide prevalence according to American College of Rheumatology (ACR) 2010 diagnostic criteria is estimated under 5,4%. In USA the burden caused by FM is estimated at 29 billions every year, due to assistance, health care costs and retirement to loss of productivity. It is known that conventional pharmacological approaches present poor therapeutic response in more than 50% of these patients. It is conceivable that this limited results, at least in part, due to the lack of a complete elucidation of its pathophysiology. Our hypothesis is that tDCS has a superior effect on clinical outcomes, functional capacity, cortical excitability, and psycho-affective functions compared to simulated treatment. In order to respond to the objectives of this study, a randomized, parallel-blinded clinical trial will be conducted. FM patients will be randomized to receive tDCS with anodic pole on the primary motor cortex and the cathode pole on the contralateral prefrontal cortex.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03843203
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03843203 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital de Clinicas de Porto Alegre
- Last refreshed: 18 February 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03843203.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing