Effectiveness of tDCS for the Treatment of Functional Dyspepsia

May 17, 2016 updated by: Carine Leite, Hospital Ernesto Dornelles

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90160-093
        • Recruiting
        • Hospital Ernesto Dornelles - Endoscopy Unit
        • Contact:
          • Carine Leite, MD
        • Contact:
          • Guilherme B Sander, MD, PhD
        • Principal Investigator:
          • Guilherme B Sander, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HADS score
Time Frame: 4 weeks
Decrease in HADS score
4 weeks
SF36 score
Time Frame: 4 weeks
Decrease in SF36 score
4 weeks
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
1 and 4 weeks
Self-reported treatment response
Time Frame: 1 and 4 weeks
Questionnaire for self-reporting and graduating: worsening/no improvement/improvement after treatment
1 and 4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse reactions
Time Frame: Daily from day of inclusion until day 5
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).
Daily from day of inclusion until day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Ernesto Dornelles

Investigators

  • Principal Investigator: Guilherme B Sander, PhD, Endoscopy and Gastroenterology Unit Coordinator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

November 17, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Estimate)

May 19, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 50793815900005304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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