Effectiveness of tDCS for the Treatment of Functional Dyspepsia
Effectiveness of Transcranial Direct Current Stimulation for the Treatment of Functional Dyspepsia: a Randomized Controlled Trial
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2016
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2015
CompletedFirst Posted
Study publicly available on registry
November 20, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedMay 19, 2016
March 1, 2016
3 years
November 17, 2015
May 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PADYQ score
Decrease in PADYQ (Porto Alegre Dyspepsia Symptoms Questionnaire) score
4 weeks
Secondary Outcomes (4)
HADS score
4 weeks
SF36 score
4 weeks
Use of drugs for dyspeptic symptoms
1 and 4 weeks
Self-reported treatment response
1 and 4 weeks
Other Outcomes (1)
Adverse reactions
Daily from day of inclusion until day 5
Study Arms (2)
anodal tDCS
EXPERIMENTALTDCS 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 COMPARATORTwo 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.
Interventions
tDCS anodal stimulation over M1 area applied for 20 minutes at five consecutive days.
tDCS sham stimulation over M1 applied for 20 minutes (with current turned off at 30 seconds) at five consecutive days.
Eligibility Criteria
You may qualify if:
- functional dyspeptic patients according to Rome IV criteria
- clinical investigation reporting absence of organic causes of functional dyspepsia
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Ernesto Dornelles - Endoscopy Unit
Porto Alegre, Rio Grande do Sul, 90160-093, Brazil
Related Publications (3)
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.
PMID: 22037126BACKGROUNDMa 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.
PMID: 22243034BACKGROUNDMarlow 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.
PMID: 22631436BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guilherme B Sander, PhD
Endoscopy and Gastroenterology Unit Coordinator
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Carine Leite, MD
Study Record Dates
First Submitted
November 17, 2015
First Posted
November 20, 2015
Study Start
January 1, 2016
Primary Completion
January 1, 2019
Study Completion
January 1, 2020
Last Updated
May 19, 2016
Record last verified: 2016-03