Effectiveness of tDCS for the Treatment of Functional Dyspepsia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02611414|
Recruitment Status : Recruiting
First Posted : November 20, 2015
Last Update Posted : May 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Dyspepsia||Device: anodal tDCS Device: Sham tDCS||Phase 2 Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effectiveness of Transcranial Direct Current Stimulation for the Treatment of Functional Dyspepsia: a Randomized Controlled Trial|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2020|
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.
- PADYQ score [ Time Frame: 4 weeks ]Decrease in PADYQ (Porto Alegre Dyspepsia Symptoms Questionnaire) score
- 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
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02611414
|Contact: Carine Leite, MD||55 51 firstname.lastname@example.org|
|Contact: Guilherme B Sander, MD, PhD||55 51 email@example.com|
|Hospital Ernesto Dornelles - Endoscopy Unit||Recruiting|
|Porto Alegre, RS, Brazil, 90160-093|
|Contact: Carine Leite, MD|
|Contact: Guilherme B Sander, MD, PhD|
|Principal Investigator: Guilherme B Sander, MD, PhD|
|Principal Investigator:||Guilherme B Sander, PhD||Endoscopy and Gastroenterology Unit Coordinator|