Effectiveness of transcraneal direct current stimulation (tDCS) for the treatment of fibromyalgia: Comparison of cortical targets effects on main fibromyalgia symptoms (tDCS for the treatment of fibromyalgia)

Study identification

• EU PAS number:
  EUPAS24294
• Study ID:
  24295
• Official title and acronym:
  Effectiveness of transcraneal direct current stimulation (tDCS) for the treatment of fibromyalgia: Comparison of cortical targets effects on main fibromyalgia symptoms (tDCS for the treatment of fibromyalgia)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Fibromyalgia is a common cause of diffuse, chronic musculoskeletal pain in adults, with an estimated prevalence between 2 and 5% in the general population. Even though its aetiology and pathophysiology are not fully understood, current evidence suggests that, similarly to other chronic pain syndromes, this is a disorder of pain regulation characterized by altered pain and sensory processing in the central nervous system, likely due to maladaptive plasticity in pain-related neural circuits. Thus, the use of neuro-stimulation approaches is of particular relevance in fibromyalgia, a chronic pain disorder where pain can be characterized by a lack of inhibitory control over somatosensory processing and that is often refractory to multiple therapeutic strategies.Transcranial direct current stimulation (tDCS) is a promising technique that allows to non-invasively modulate brain activity by applying a low intensity current (1 to 2 mA) via scalp electrodes. Stimulation effects and after-effects depend on the current polarity under each electrode. Indeed, motor cortex stimulation studies have shown that with standard parameters, anodal stimulation enhances cortical excitability, while cathodal stimulation decreases cortical excitability.Some studies have explored the analgesic effects of tDCS in chronic pain, including fibromyalgia, both stimulating M1 and/or the dorso-lateral prefrontal cortex (DLPFC, F3). However, a recent meta-analysis has stressed the poor methodological quality of most previous studies, leading to non-significant results of and the need for larger, rigorously designed studies. This study aims to obtain more information on the therapeutic use of tDCS for pain relief, and to respond to two important challenges of this area of research: (a) the need of more sham-controlled studies with a sufficient number of patients and long follow-up, (b) the need to explore novel targets in pain-related brain regions, such as the operculo-insular cortex.
• Study status:
  Planned

Research institutions and networks

Institutions

Health Research Institute of Santiago de Compostela (IDIS)

Hospital Complex of Pontevedra Pontevedra (Spain)

Study timelines

Date when funding contract was signed

Planned:02/06/2018

Study start date

Planned:02/06/2018

Data analysis start date

Planned:02/06/2018

Date of interim report, if expected

Planned:02/06/2018

Date of final study report

Planned:03/09/2018

Sources of funding

Other

More details on funding

Spanish National Plan

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable