Biological and Psychological Markers After Trancranial Electrical Stimulation in Adults With Generalized Anxiety Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in Generalized Anxiety Symptoms as Assessed by the GAD-7 Scale
研究概览
简要总结
This clinical trial inestigates the effects of transcranial direct current stimulation (tDCS) on anxiety symptoms in adult women with clinically relevant anxiety levels. The intervention involves the application of low-intensity electrical current over the left dorsolateral prefrontal cortex (DLPFC) across twenty consecutive sessions. Participants are randomly assigned to either an active or sham stimulation group in a double-blind design. The study aims to evaluate changes in anxiety symptoms, emotional regulation, and physiological and molecular markers, including EEG activity, heart rate variability (HRV), and salivary levels of cortisol and interleukin-6 (IL-6) plasma. The findings are expected to support the development of complementary, low-cost, and non-pharmacological strategies for anxiety management.
详细描述
Anxiety is one of the biggest causes of disability in the world, and many patients do not respond to conventional treatments. Due to this situation, studies were carried out to understand better understand the mechanisms of psychiatric disorders, and one of the alternatives found was the non-invasive brain stimulation with transcranial direct current (tDCS). The project in question aims to evaluate the effectiveness of tDCS-based intervention in adults with anxiety, comparing with a control group. The results will be measured through questionnaires and tests cognitive effects, as well as analyzes of physiological data and inflammatory markers. The study will be done through an experimental and a control group, with 49 men and women in each group. All data will be collected at the Neuromodulation laboratory at Hospital de Clínicas de Porto Alegre, under the coordination of Professor Wolnei Caumo. Participants will be recruited through previously registered patients on Neuromodulation laboratory at Hospital de Clínicas de Porto Alegre database, and the inclusion criteria and exclusion will be defined according to values of anxiety scales and other characteristics of health. The entire process will be conducted safely. Participants in the experimental and control will have their data collected on the first and last day of the intervention. Each participant will receive a placebo or control intervention of 20 sessions, between the first and the last, and will be blinded between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The researcher will receive equipment already programmed by a research assistant, therefore, the researcher who will deliver the tDCS to perform the stimulation will not know the programmed stimulation. Patients will be instructed to discuss aspects of treatment with the respective investigator. Two independent assessors who will not participate in consultations where guidance on the use of tDCS will be provided will be trained to assess follow-up outcomes. Patients will not know the type of intervention received, as the sham condition produces a stimulus, but without the expected effects. Blinding will be evaluated at the end of treatment using a standardized instrument.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adults under the age of 18;
- •GAD-7 ≥ 10
- •Possibility of being present on previously agreed days.
排除标准
- •Being in psychopharmacological treatment for depression;
- •HAM-D≥23 scale;
- •have a self-reported severe disorder (psychosis, schizophrenia, substance abuse, major depression);
- •having had seizures and epilepsy;
- •having presented substance use disorder (except Tobacco) in the last 6 months or Suicidal Ideation in the last 6 months;
- •being pregnant or breastfeeding;
- •have suffered any type of brain injury or surgery, heart disease or cranial defect.
研究组 & 干预措施
responds to the placebo effect Intervention: Transcranial Direct Current Stimulation - tDCS
Patients will receive tDCS stimulation treatment dorsolateral prefrontal cortex. According to the 10-20 EEG system, the anode will be placed on the left F3 and the cathode on the contralateral F4.
Placebo stimulation uses a current of 2 milliamps for the first 30 seconds and again for the last 30 seconds. The tDCS application time will be 20 minutes Device: s-tDCS - Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it
Device: a-tDCS
- Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it
干预措施: 'Transcranial Direct Current Stimulation - tDCS (Device)
No placebo effect responds Intervention: Transcranial Direct Current Stimulation - tDCS
Patients will receive tDCS stimulation treatment dorsolateral prefrontal cortex According to the 10-20 EEG system, the anode will be placed on the left F3 and the cathode on the contralateral F4.
Active stimulation uses a current of 2 milliamps for 20 minutes. Device: s-tDCS - Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it
Device: a-tDCS
- Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it
干预措施: 'Transcranial Direct Current Stimulation - tDCS (Device)
结局指标
主要结局
Change in Generalized Anxiety Symptoms as Assessed by the GAD-7 Scale
时间窗: 1 month
Change in anxiety symptoms will be assessed by the total change in the GAD-7 score, a 7-item self-administered scale that measures the severity of anxiety symptoms. Scores range from 0 to 21, with higher scores indicating greater anxiety severity.
次要结局
- Change in Heart Rate Variability (HRV) as Assessed by the Standard Deviation of NN Intervals (SDNN)(1 month)
- Change in the Anxiety Sensitivity Index-Revised (ASI-R) Total Score(1 month)
- Change in Pain Intensity as Measured by the Central Sensitization Inventory (CSI) score(1 month)
- Change in Subjective Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI) score(1 month)
- Change in Absolute Alpha Band Power (8-12 Hz) at Electrode Site [F3/F4/C3/C4/P3/P4] as Assessed by Electroencephalogram (EEG).(1 month)
- Change in Interhemispheric Absolute Alpha Band Power Asymmetry (8-12 Hz) Between [F3 and F4 / C3 and C4 / P3 and P4] as Assessed by Electroencephalogram (EEG)(1 month)