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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anodal tDCS | Experimental | 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. |
|
| Sham tDCS | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anodal tDCS | Device | tDCS anodal stimulation over M1 area applied for 20 minutes at five consecutive days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PADYQ score | Decrease in PADYQ (Porto Alegre Dyspepsia Symptoms Questionnaire) score | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HADS score | Decrease in HADS score | 4 weeks |
| SF36 score | Decrease in SF36 score | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse reactions | 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). | Daily from day of inclusion until day 5 |
Inclusion Criteria:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carine Leite, MD | Contact | 55 51 97420351 | carineleite@hotmail.com | |
| Guilherme B Sander, MD, PhD | Contact | 55 51 32178885 | guilherme.sander@sisqualis.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Guilherme B Sander, PhD | Endoscopy and Gastroenterology Unit Coordinator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Ernesto Dornelles - Endoscopy Unit | Recruiting | Porto Alegre | Rio Grande do Sul | 90160-093 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22037126 | Background | 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. | |
| 22243034 |
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| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Sham tDCS | Device | tDCS sham stimulation over M1 applied for 20 minutes (with current turned off at 30 seconds) at five consecutive days. |
|
| Use of drugs for dyspeptic symptoms | Questionnaire about the drugs and number of weekly pills used for symptomatic relief of functional dyspepsia symptoms | 1 and 4 weeks |
| Self-reported treatment response | Questionnaire for self-reporting and graduating: worsening/no improvement/improvement after treatment | 1 and 4 weeks |
| 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. |
| 22631436 | Background | 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. |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |