Clinical Trial: Effectiveness of tDCS for the Treatment of Functional Dyspepsia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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 Summary:

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.


Sponsor: Hospital Ernesto Dornelles

Current Primary Outcome: PADYQ score [ Time Frame: 4 weeks ]

Decrease in PADYQ (Porto Alegre Dyspepsia Symptoms Questionnaire) score


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome:

  • HADS score [ Time Frame: 4 weeks ]
    Decrease in HADS score
  • SF36 score [ Time Frame: 4 weeks ]
    Decrease in SF36 score
  • Use of drugs for dyspeptic symptoms [ Time Frame: 1 and 4 weeks ]
    Questionnaire about the drugs and number of weekly pills used for symptomatic relief of functional dyspepsia symptoms


Information By: Hospital Ernesto Dornelles

Dates:
Date Received: November 17, 2015
Date Started: January 2016
Date Completion: January 2020
Last Updated: May 17, 2016
Last Verified: March 2016