Effectiveness of tDCS for the Treatment of Functional Dyspepsia

Effectiveness of Transcranial Direct Current Stimulation for the Treatment of Functional Dyspepsia: a Randomized Controlled Trial

Functional dyspepsia is a very common disorder of great challenge to clinical management. A therapeutic targets is up-regulation of visceral pain threshold. The transcranial direct current stimulation (tDCS) is a novel therapy that pursues these properties, besides its safety and easy adherence. There is a great need of new treatments for functional dyspepsia. There is no current study evaluating tDCS for this disease.

Functional dyspepsia is a high prevalent disease with substantial costs to health system. There are many available treatments, but disappointing results are reported in clinical trials. TDCS is a noninvasive, secure and painless technique of brain stimulation. It is delivered by a battery-operated device that transfers low intensity electrical current to all surface of the brain. Then there is a modulation of cortical excitability and influence on central neurological functions. It has been reported its efficacy for the treatment of many diseases such as depression and chronic pain. Impairment of central mechanisms of interpretation and threshold of pain are related to functional dyspepsia. Therefore, tDCS may benefit dyspeptic patients. This study is a double blind randomized controled trial to test tDCS effectiveness on functional dyspepsia. Seventy functional dyspeptic patients will be enrolled, being randomized to either tDCS or sham tDCS.

TDCS will be delivered with two saline-soaked sponge electrodes. The main electrode to anodal stimulation will be placed over the motor cortex, M1. The second electrode is neutral and will be placed on the skin overlying the supraorbital region The current will be delivered at the intensity of 2mA for 20 minutes. The procedure will be repeated at five consecutive days.

Two electrodes are positioned at M1 and supra-orbital área. To deliver sham, the current will be delivered for 30 sec only to elicit tingling skin sensation but no cortical excitability changes. The procedure will be repeated at five consecutive days.

tDCS sham stimulation over M1 applied for 20 minutes (with current turned off at 30 seconds) at five consecutive days.

Questionnaire about the drugs and number of weekly pills used for symptomatic relief of functional dyspepsia symptoms

Questionnaire for self-reporting and graduating: worsening/no improvement/improvement after treatment

A questionnaire to point out if presence of one or more of the 8 previously reported adverse effects of tDCS (such as headache and burning sensation).

Inclusion Criteria: functional dyspeptic patients according to Rome IV criteria clinical investigation reporting absence of organic causes of functional dyspepsia Exclusion Criteria history of brain trauma, haemorrhage or ischemia implantable devices such as pacemaker alcohol or drug abuse epilepsy severe chronic disease non-acceptance to sign up the term of consent.

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