Transcranial direct current stimulation (tDCS) combined with pain cognition training for fibromyalgia
Anodal dorsolateral prefrontal cortex (DLPFC) tDCS combined with pain cognition training for fibromyalgia: A pilot randomised control trial
Bernadette Fitzgibbon
40 participants
Jul 20, 2020
Interventional
Conditions
Summary
Fibromyalgia is a complex chronic disorder affecting 2-4% of the population. It is a debilitating condition that has substantial consequences for the individual, their family and the economy. Current treatments are predominantly pharmacological interventions with either no evidence or little support for efficacy and/or associated with significant side effects. There is therefore an urgent need to develop non-pharmaceutical treatments. One potential option is pain cognition training, which is thought to work via the reconceptualization of maladaptive pain cognitions. Although a promising area, research in this field has shown only moderate effects at best. In this study, we will examine whether combining transcranial direct current stimulation (tDCS), a form of non-invasive brain stimulation, to pain cognition training enhances treatment outcomes by acting on synergistic neural processes. If successful in finding that the combined treatment is better than pain cognition training alone, this study has the potential to offer better patient care than is currently available. Forty adult participants with a diagnosis fibromyalgia will be recruited for this randomized, double-blind, placebo-controlled study. Participants will be randomized into one of two treatment groups (active tDCS with pain cognition training, or sham tDCS with pain cognition training) for a 4 week daily (Monday-Friday) treatment course. At each treatment session participants will receive 20 minutes of active tDCS or sham (placebo) tDCS, followed by 30 minutes of cognition training, 3 times per treatment week (i.e. tues-thurs for each of the four weeks). Participants will complete symptom-related questionnaires and undergo a pain assessment at baseline, at the end of each treatment week (1-4), as well as at a follow-up appointment one-month following the completion of treatment. Data collected from these questionnaires and the pain assessments will be compared between the active tDCS group and placebo tDCS group using repeated measures analysis.
Eligibility
Inclusion Criteria4
- Patients will be included if they:
- A formal diagnosis of fibromyalgia
- Aged between 18 and 70 years old
- Have no increase or initiation of new medication therapy in the 8 weeks prior to screening and maintain existing medication regimen throughout this study’s treatment course.
Exclusion Criteria4
- Participants who:
- Have a medical history of any a neurological disorder (including epilepsy and head injury) or are currently pregnant or lactating.
- Have a current DSM-V diagnosis of any psychiatric condition; excluding depression, anxiety and PTSD, unless identified as primary disorder.
- Any contraindication to transcranial electrical stimulation; including presence of metal inside the head (excluding dental work) or body.
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Interventions
transcranial direct current stimulation (tDCS) plus pain cognition training Participants will undergo 20 treatment sessions across 4 weeks (Monday-Friday). At each treatment session, participants will undergo tDCS. Participants will be randomly allocated to receive active or sham tDCS. Active tDCS will be applied using two 35cm2 electrodes with a electrical current of 0.057mA/cm2 for 20 minutes. The anode electrode will be placed over the left DLPFC, and the cathode electrode over the right supraorbital region. Three times per week (i.e. tues-thurs for each of the four weeks), participants will engage in pain cognition training for 30 minutes immediately following tDCS . The training involves the use of a self-administered paper workbook that allows participants to identify the triggers and modifiers of their pain, and will be used in conjunction with a paper-based pain education resource. Both the workbook and the pain education resource are developed by the Neuro Orthopaedic Institute Group. tDCS and Pain Cognition training will be administered/overseen by a trained researcher or clinician at Monash Alfred Psychiatry Research Centre. Fidelty of tDCS blinding: both the subject and investigator administering stimulation will be blinded. An independent researcher will assign participants codes for active and sham treatments. The tDCS administrator simply enters the code into the machine which will conduct an active or sham session according to the code entered. We will also be conducting blinding questionnaires with participants to assess the fidelity of the blinding.
Locations(1)
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ACTRN12616001682437