Dyspepsia
Conditions
Keywords
functional dyspepsia, tDCS
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.
Interventions
DEVICEanodal tDCS
tDCS anodal stimulation over M1 area applied for 20 minutes at five consecutive days.
DEVICESham tDCS
tDCS sham stimulation over M1 applied for 20 minutes (with current turned off at 30 seconds) at five consecutive days.
Sponsors
Hospital Ernesto Dornelles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PADYQ score | 4 weeks | Decrease in PADYQ (Porto Alegre Dyspepsia Symptoms Questionnaire) score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse reactions | 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). |
Countries
Brazil
Contacts
Primary ContactCarine Leite, MD
Backup ContactGuilherme B Sander, MD, PhD
Outcome results
None listed