Clinical trial NCT02611414: Effectiveness of tDCS for the Treatment of Functional Dyspepsia
Official title: Effectiveness of Transcranial Direct Current Stimulation for the Treatment of Functional Dyspepsia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Dyspepsia
Keywords: functional dyspepsia
tDCS
Lead sponsor: Hospital Ernesto Dornelles
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: PADYQ score
timeFrame: 4 weeks
Secondary outcomes:
measure: HADS score
timeFrame: 4 weeks
measure: SF36 score
timeFrame: 4 weeks
measure: Use of drugs for dyspeptic symptoms
timeFrame: 1 and 4 weeks
measure: Self-reported treatment response
timeFrame: 1 and 4 weeks
Other outcomes:
measure: Adverse reactions
timeFrame: Daily from day of inclusion until day 5
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital Ernesto Dornelles - Endoscopy Unit
state: RS
Study officials:
affiliation: Endoscopy and Gastroenterology Unit Coordinator
name: Guilherme B Sander, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.
citation: Ma TT, Yu SY, Li Y, Liang FR, Tian XP, Zheng H, Yan J, Sun GJ, Chang XR, Zhao L, Wu X, Zeng F. Randomised clinical trial: an assessment of acupuncture on specific meridian or specific acupoint vs. sham acupuncture for treating functional dyspepsia. Aliment Pharmacol Ther. 2012 Mar;35(5):552-61. doi: 10.1111/j.1365-2036.2011.04979.x. Epub 2012 Jan 16.
citation: Marlow NM, Bonilha HS, Short EB. Efficacy of transcranial direct current stimulation and repetitive transcranial magnetic stimulation for treating fibromyalgia syndrome: a systematic review. Pain Pract. 2013 Feb;13(2):131-45. doi: 10.1111/j.1533-2500.2012.00562.x. Epub 2012 May 28.