tDCS: 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.
tVNS: 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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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 outcome measure(s)
Stress Symptoms assessment — From enrollment to follow up at 1 month 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.
Perceived Stress assessment — From enrollment to follow up at 1 month 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.
Trial sites (1)
Facility
City
Region
Status
Egas Moniz Scholl Of Health and Science
Almada
Setúbal District
More Egas Moniz - Cooperativa de Ensino Superior, CRL trials in Portugal
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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