EEG Prediction and Clinical Efficacy of tDCS in Fibromyalgia.
ConditionFibromyalgia (FM)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIonclinics & Deionic SL
About this trial
The purpose of this randomized controlled trial is to investigate the non-inferiority, and possible superiority, of a high-dose home-based tDCS protocol compared with a conventional home-based protocol, and to assess its cost-effectiveness, in patients with fibromyalgia.
As complementary goals, we aim to assess the predictive value of baseline EEG for clinical response to high-dose home-based tDCS treatment; and to describe the effectiveness of a high-dose home-based protocol applied to the motor cortex (M1) versus the dorsolateral prefrontal cortex (DLFPC) in patients with fibromyalgia.
Eligibility criteria
Qualifiers
Widespread Pain Index (WPI) ≥7 and Symptom Severity Scale (SSS) score ≥5 or a WPI score of 4-6 and SSS ≥9
Presence of widespread pain, defined as pain in at least 4 of 5 regions. Jaw, chest, and abdominal pain are not included in the definition of widespread pain.
Symptoms have been generally present for at least 3 months.
The diagnosis of fibromyalgia (FM) is valid regardless of other diagnoses. The diagnosis of FM does not exclude the presence of other clinically significant diseases.
Disqualifiers
Presenting with immune system disorders or comorbidities that explain the main symptoms of fibromyalgia: rheumatoid arthritis, lupus, autoimmune, neurological, and oncological disorders.
Presenting with any uncompensated clinical condition such as ischemic heart disease, kidney disease, or liver disease.
Presenting with dermatological conditions, such as allergic skin reactions at the electrode sites, psoriasis, etc.
Metallic implants or head injuries, any electronic device such as cochlear implants or cardiac pacemakers.
Trial design
Treatments tested in this trial
- High-dose home-tDCS M1
- Conventional home-tDCS
- High-dose home-tDCS DLPFC
Treatment groups
250 Participants
are divided into 3 treatment groupsSponsors and collaborators
Ionclinics & Deionic SL
Lead sponsor
Hospital Clínico Universitario de Valencia
Collaborator
Source ClinicalTrials.gov