跳至主要内容
临床试验/NCT06813209
NCT06813209尚未招募不适用

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

Egas Moniz - Cooperativa de Ensino Superior, CRL1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Stress Symptoms assessment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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;
  • •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.

研究组 & 干预措施

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.

干预措施: tVNS (Device)

tDCS True Modulation

Experimental

Participants will be delivered true treatment for 20 minutes each session

干预措施: tDCS (Device)

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.

干预措施: tDCS (Device)

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.

干预措施: tVNS (Device)

结局指标

主要结局

Stress Symptoms assessment

时间窗: 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

时间窗: 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.

次要结局

  • Distress Assessment(From enrollment to followup at 1 month)
  • Sleep Quality(From enrollment to follow up at 1 month)

研究者

发起方
Egas Moniz - Cooperativa de Ensino Superior, CRL
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验