Effectiveness of tDCS for the Treatment of Functional Dyspepsia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Dyspepsia

Intervention / Treatment
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* Device: anodal tDCS
* Device: Sham tDCS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anodal tDCS<br>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. | Device: anodal tDCS<br>* tDCS anodal stimulation over M1 area applied for 20 minutes at five consecutive days.<br>|
| Sham Comparator: Sham tDCS<br>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. | Device: Sham tDCS<br>* tDCS sham stimulation over M1 applied for 20 minutes (with current turned off at 30 seconds) at five consecutive days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PADYQ score | Decrease in PADYQ (Porto Alegre Dyspepsia Symptoms Questionnaire) score | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HADS score | Decrease in HADS score | 4 weeks | 
| SF36 score | Decrease in SF36 score | 4 weeks | 
| Use of drugs for dyspeptic symptoms | Questionnaire about the drugs and number of weekly pills used for symptomatic relief of functional dyspepsia symptoms | 1 and 4 weeks | 
| Self-reported treatment response | Questionnaire for self-reporting and graduating: worsening/no improvement/improvement after treatment | 1 and 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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functional dyspepsia, tDCS