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Trial record 3 of 41 for:    Recruiting, Not yet recruiting, Available Studies | "Dyspepsia"

Effectiveness of tDCS for the Treatment of Functional Dyspepsia

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ClinicalTrials.gov Identifier: NCT02611414
Recruitment Status : Recruiting
First Posted : November 20, 2015
Last Update Posted : May 19, 2016
Information provided by (Responsible Party):
Carine Leite, 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.

Condition or disease Intervention/treatment Phase
Dyspepsia Device: anodal tDCS Device: Sham tDCS Phase 2 Phase 3

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  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. PADYQ score [ Time Frame: 4 weeks ]
    Decrease in PADYQ (Porto Alegre Dyspepsia Symptoms Questionnaire) score

Secondary Outcome Measures :
  1. HADS score [ Time Frame: 4 weeks ]
    Decrease in HADS score

  2. SF36 score [ Time Frame: 4 weeks ]
    Decrease in SF36 score

  3. 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

  4. Self-reported treatment response [ Time Frame: 1 and 4 weeks ]
    Questionnaire for self-reporting and graduating: worsening/no improvement/improvement after treatment

Other Outcome Measures:
  1. 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).

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 97420351 carineleite@hotmail.com
Contact: Guilherme B Sander, MD, PhD 55 51 32178885 guilherme.sander@sisqualis.com.br

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         
Sponsors and Collaborators
Hospital Ernesto Dornelles
Principal Investigator: Guilherme B Sander, PhD Endoscopy and Gastroenterology Unit Coordinator

Responsible Party: Carine Leite, Carine Leite, MD, Hospital Ernesto Dornelles
ClinicalTrials.gov Identifier: NCT02611414     History of Changes
Other Study ID Numbers: 50793815900005304
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: March 2016

Keywords provided by Carine Leite, Hospital Ernesto Dornelles:
functional dyspepsia

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms