Effectiveness of tDCS for the Treatment of Functional Dyspepsia

Phase 2

• Conditions: Dyspepsia
• Interventions: Device: anodal tDCS; Device: Sham tDCS

• Registration Number: NCT02611414
• Lead Sponsor: Hospital Ernesto Dornelles

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 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 Timeline

• Study First Submitted: 2015-11-17
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-20
• Study Start: 2016-01
• Status Verified: 2016-03
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-19
• Primary Completion: 2019-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anodal tDCS	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.
Sham tDCS	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.

Primary Outcome Measures

Name	Time	Method
PADYQ score	4 weeks	Decrease in PADYQ (Porto Alegre Dyspepsia Symptoms Questionnaire) score

Secondary Outcome Measures

Name	Time	Method
HADS score	4 weeks	Decrease in HADS score
SF36 score	4 weeks	Decrease in SF36 score
Use of drugs for dyspeptic symptoms	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	1 and 4 weeks	Questionnaire for self-reporting and graduating: worsening/no improvement/improvement after treatment

Trial Locations

Locations (1)

Hospital Ernesto Dornelles - Endoscopy Unit; 🇧🇷 Porto Alegre, RS, Brazil