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 type

• Study type:
  Clinical trial
• Scope of the study:
  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Explore novel targets in pain-related brain regions, such as the operculo-insular cortex

Clinical trials

• Clinical trial randomisation:
  Randomised clinical trial

Study drug and medical condition

• Medical condition to be studied:
  Fibromyalgia

  Pain management

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)
• Estimated number of subjects:
  92

Study design details

• Main study objective:
  1) to compare the analgesic effect of M1 active tDCS vs sham tDCS in a group of patients with FM, 2) to analyze long-term effects (6, 12 m) of tDCS on pain and associated symptoms, 3) to check the effect of DLPFC active tDCS vs sham tDCS on cognitive function, 4) to determine the optimum tDCS stimulation place (M1, OIC or DLPFC) for each of a group of four symptoms considered in FM patients.
• Outcomes:
  To assess treatment effectiveness we will consider 4 groups of symptoms, each with defined outcome measures.1. Pain, fatigue (mean threshold by algometry, FIQ items 5 and 6)2. Mood state (HADS score)3. Cognitive dysfunction (MFE score)4. Sleep disorders (PSQI score)A 20% of change between the pre and post treatment in any of the groups will be consider an index of a clinical improvement. Assessment of general quality of life, functional impact and electroencephalogram (EEG) parameters.
• Data analysis plan:
  Patients agreeing to participate will be scheduled for a 1st evaluation session. Once informed about the characteristics of the tDCS, results of previous studies with chronic pain patients, and safety aspects, a written informed consent will be required of them. We’ll use strict inclusion/ exclusion criteria.For inclusion: fulfillment of both the ACR criteria of 1990 and 2010 (Wolfe et al.), moderate to high severity of the disease (indicated by a FIQ score >/=70 or a VAS Pain >/= 7), presence of cognitive dysfunction (item 2 “cognitive troubles” of the Symptom SS >/=2).For exclusion: no immune system pathology or comorbidities that could explain the main symptomatology of FM, risk factors for the tDCS procedure, such as existence of a history of previous convulsions (epilepsy or family history), use of anticonvulsant treatment (e.g, pregabalin, caarbamazepine, gabapentin), substance abuse, psychiatric diseases, other than depression and anxiety, brain damage, dementia, Parkinson's