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| Name | Class |
|---|---|
| Universidade Federal de Alfenas | OTHER |
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This clinical trial aims to determine if Transcranial electrical stimulation by direct current (tDCS) and transauricular Vagus Nerve Stimulation (tVNS) treatments are effective in reducing stress symptoms, distress and improving sleep quality in adults. The main questions it aims to answer are:
Stress is a disorder that significantly impacts the lives of affected individuals. Pharmacological treatment has limitations, justifying the search for non-pharmacological interventions. tDCS is a technique that modulates neuronal excitability and has shown promising results in various disorders.
Psychological stress affects a wide range of brain functions and poses risks for many mental disorders. However, effective therapies to alleviate or reverse its deleterious effects are lacking. Given that the pathophysiology of stress involves brain regions such as the prefrontal cortex, central amygdaloid nucleus, amygdala, medial amygdaloid nucleus, and ventral hippocampus, thus making the condition complex, there is a need for studies evaluating the effects of this intervention. We aim to contribute to the understanding of the role of tDCS and tVNS in managing stress.
Before participating in this research, volunteers will receive all information related to the study's objectives and methodological procedures. After agreeing to participate, they will sign the Informed Consent Form.
Study Location Patients will be selected following an evaluation based on inclusion and exclusion criteria and referred to the Clinic School of the Federal University of Alfenas (MG/Brazil), at the Laboratory of Neuroscience, Neuromodulation, and Pain Study (LANNED), located in the city of Alfenas, Minas Gerais, and at the Neuromodulation and Pain Unit (UNP) by the Egas Moniz Center for Interdisciplinary Research (CiiEM) of the Egas Moniz School of Health and Science, in the municipality of Almada, Setúbal - Portugal.
The design of the double-blind randomized clinical trial will be conducted, ensuring that participants are randomly assigned to experimental and sham groups and that the researcher applying the technique and the participants will not be aware of the allocation. The protocol will consist of 5 consecutive sessions of 20 minutes each. Data related to the anamnesis, ISSL, PSS-10, and PSQI will be evaluated at five different time points (Figure 1): before the intervention (T0), immediately after the end of the intervention (T1), and four weeks (T2) after the intervention ends (follow-up), following the CONSORT/2010 recommendations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS True Modulation | Experimental | Participants will be delivered true treatment for 20 minutes each session |
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| tDCS Sham group | Sham Comparator | Sham group will be delivers a simulated treatment; the current will be applied for only 60 seconds, with the setup remaining in place for 20 minutes. |
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| tVNS True | Experimental | For true tVNS stimulation, the technique will be performed with the electrodes positioned on the upper concha of the left ear, using gel for better current distribution. |
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| tVNS Sham | Sham Comparator | For sham tVNS stimulation, the technique will be performed in the same way as true stimulation; however, the device will be programmed to deliver 0 Hz. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS | Device | For true tDCS, the technique will be performed with the anode over the right dorsolateral prefrontal cortex and the cathode over the left dorsolateral prefrontal cortex, positioned at F4 and F3, respectively, according to the International 10/20 Electrode Placement System. The current intensity will be set to 2 milliamperes (mA) for 20 minutes over five consecutive days. |
| Measure | Description | Time Frame |
|---|---|---|
| Stress Symptoms assessment | Stress will be assessed using self reported Lipp's Inventory of Stress Symptoms for Adults (LISS). The LISS consists of a questionnaire that assesses physical and psychological symptoms of stress across three time frames: alert (ranging from 0 to 15), resistance (ranging from 0 to 15), quasi-exhaustion or exhaustion (ranging from 0 to 23). Higher scores mean a worse outcome. | From enrollment to follow up at 1 month |
| Perceived Stress assessment | Perceived Stress will be assessed using the Perceived Stress Scale (PSS-10). The test ranges from 0 (min) to 40 (max). Higher scores mean a a worst outcome. | From enrollment to follow up at 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Distress Assessment | Distress will be assessed using the Kessler Psychological Distress Scale (K10). the scale range is from 10 (min) to 50 (max). Higher scores mean a worse outcome. | From enrollment to followup at 1 month |
| Sleep Quality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luciano Maia Alves Ferreira, PhD | Contact | +351913548646 | lucianomaia@egasmoniz.edu.pt |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Egas Moniz Scholl Of Health and Science | Almada | Setúbal District | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22037126 | Result | 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. | |
| 33799722 |
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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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| tVNS | Device | For true tVNS stimulation, the technique will be performed with the electrodes positioned on the upper concha of the left ear, using gel for better current distribution. |
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Stress will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The global PSQI score ranges from 0 to 21. Higher scores mean a worse outcome
| From enrollment to follow up at 1 month |
| Alyan E, Saad NM, Kamel N, Yusoff MZ, Zakariya MA, Rahman MA, Guillet C, Merienne F. Frontal Electroencephalogram Alpha Asymmetry during Mental Stress Related to Workplace Noise. Sensors (Basel). 2021 Mar 11;21(6):1968. doi: 10.3390/s21061968. |
| 25874165 | Result | Loftus AM, Yalcin O, Baughman FD, Vanman EJ, Hagger MS. The impact of transcranial direct current stimulation on inhibitory control in young adults. Brain Behav. 2015 May;5(5):e00332. doi: 10.1002/brb3.332. Epub 2015 Mar 19. |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |