Effectiveness of tDCS for the Treatment of Functional Dyspepsia

Hospital Ernesto Dornelles

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Dyspepsia

Treatments: Device: anodal tDCS; Device: Sham tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT02611414

50793815900005304

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

anodal tDCS

Experimental group

Description:

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.

Treatment:

Device: anodal tDCS

Sham tDCS

Sham Comparator group

Description:

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.

Treatment:

Device: Sham tDCS