Clinical trial NCT06813209: Effects of Transcranial Electrical Stimulation in Chronic Stress
Official title: Effects of Transcranial Electrical Stimulation by Continuous Current on the Right and Left Dorsolateral Prefrontal Cortex Associated or Not with Non-invasive Vagus Nerve Stimulation in Adult Individuals with Chronic Stress
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress
Sleep
Keywords: Transcranial electrical stimulation by direct current
tDCS
non-invasive vagus nerve stimulation
stress
tVNS
Lead sponsor: Egas Moniz - Cooperativa de Ensino Superior, CRL
Sponsor class: OTHER
Collaborators: name: Universidade Federal de Alfenas
First posted: 2025-02-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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:

* Determine if tDCS effectively reduces the intensity of stress symptoms in adults.
* Determine if tDCS is effective in reducing levels of distress in adults.
* Determine if tDCS is effective in improving sleep quality.
* Determine if tVNS is effective in reducing the intensity of stress symptoms in adults.
* Determine if tVNS is effective in reducing levels of distress in adults.
* Determine if tVNS is effective in improving sleep quality.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* individuals previously diagnosed with stress.
* Obtain a score above 4 on the Lipp Adult Stress Symptom Inventory (ISSL);
* Must be able to read and understand the purpose of the research and respond to the assessment instruments.
* Must acknowledge and agree with the informed consent form.

Exclusion Criteria:

* smokers;
* be pregnant;
* initiation and/or change in psychotropic drug dosage in the last three months;
* use of anxiolytics or antidepressants;
* substance dependence;
* history of dizziness or seizures;
* signs of severity and/or indications for hospitalization or psychotherapy;
* diagnosis of depression; diagnosis of anxiety; bipolar mood disorder with depressive, manic, or hypomanic symptoms in the past year;
* schizophrenia or other psychotic disorders;
* autism;
* diagnosis of epilepsy or use of anticonvulsants;
* contraindications for tDCS (metal implants, tumor, previous brain surgery, significant cranioencephalic anatomical alterations);
* contraindications for non-invasive vagus nerve stimulation (cochlear implant, ear plastic surgery, ear malformation);
* adverse effects detected in the group treated with tDCS and tVNS, including itching, tingling, headache, burning sensation, and discomfort.

Primary outcomes:
measure: Stress Symptoms assessment
timeFrame: From enrollment to follow up at 1 month
measure: Perceived Stress assessment
timeFrame: From enrollment to follow up at 1 month
Secondary outcomes:
measure: Distress Assessment
timeFrame: From enrollment to followup at 1 month
measure: Sleep Quality
timeFrame: From enrollment to follow up at 1 month
Other outcomes:
Locations:
city: Almada
country: Portugal
facility: Egas Moniz Scholl Of Health and Science
state: Setubal
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.