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临床试验/NCT06874595
NCT06874595招募中不适用

Psychobiological Responses Following Exercise and Brain Stimulation

Virginia Commonwealth University1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2025年3月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
29
试验地点
1
主要终点
Examine the anxiolytic effects of high density transcranial direct current stimulation (HD-tDCS) "primed" with physical activity (PA)

研究概览

简要总结

Anxiety disorders are the most common mental health diagnosis in the US; 19.1% of U.S. adults (23.4% for females and 14.3% for males). In addition, the Global Burden of Disease study (2010) found that anxiety disorders were the sixth leading cause of disability (years of life lived with disability). These debilitating disorders are characterized by excessive worry and fear about everyday situations, and physical symptoms including restlessness, being easily fatigued, difficulty concentrating, irritability, muscle tension, or sleep disturbance. Furthermore, anxiety is linked to other mental disorders including depression and substance abuse; is associated with cardiovascular disease risk factors and a higher rate of cardiovascular disease; and is related to premature mortality. These data have led to the investigation of a breadth of plausible treatments for anxiety, including medications and psychotherapy. However, likely due to the breadth of complex mechanisms involved in the pathophysiology of anxiety disorders and the unfavorable side effects of various medications, a considerable number of individuals do not have a satisfactory response to these treatments. This has led investigators to examine plausible novel interventions to alleviate anxiety and its symptoms.

详细描述

Transcranial direct current stimulation (tDCS), a non-invasive central neuromodulatory technique that is inexpensive and safe, has been utilized to stimulate specific regions of the brain and has demonstrated promising results for alleviating anxiety and depression. (1) evidence supports the administration of anodal stimulation over the left dorsolateral prefrontal cortex (DLPFC) to excite neuronal activity and cathodal stimulation over the right DLPFC to inhibit activity (a bicephalic tDCS montage with 2 mA of stimulation at the left DLPFC) as the most effective tDCS treatment to alleviate anxiety in humans and (2) that "tDCS may be more effective when used in combination with drugs and cognitive behavioral therapies". However, results from studies that have examined the neurophysiological and behavioral effects of tDCS are not consistent. This is likely because the highest cortical current density may not have occurred directly under the target electrode, thus altering the effects of tDCS. High-density tDCS (HD-tDCS) is similar to conventional tDCS utilizing anode and cathode placement on the scalp to produce unidirectional current flow, however, to enhance precision and accuracy, HD-tDCS utilizes smaller electrodes and most often in a "4X1 ring" montage (center anode electrode surrounded by four return cathode electrodes). This HD-tDCS montage delivers a precise current to the intended target site and has been found to be well tolerated and safe for healthy humans. Furthermore, the utilization of HD-tDCS can facilitate the elucidation of mechanisms of action that can provide greater clarity regarding discrepant results in the literature and for considering future advancements in enhancing effective HD-tDCS implementation strategies. HD-tDCS stimulation increases the membrane potential by several millivolts without triggering an action potential.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •Healthy adults
  • •aged 18 to 50
  • •consent and complete a Physical Activity Readiness Questionnaire (PAR-Q)
  • •be free from any neurological or psychiatric disorder
  • •not be taking any medication that could affect the central nervous system
  • •not have any contraindication for HD-tDCS (i.e. not having metal implanted in the head, pacemaker, medical bumps, seizures, lesions on the scalp or head ) or for bioelectrical impedance (i.e., electronic medical implant, such as a pacemaker or implantable cardioverter defibrillator, and limb amputation)
  • •not be regular users of tobacco products (cigarettes, cigars, chewing tobacco)
  • •not consume an average of more than ten alcoholic beverages per week

排除标准

  • •Individuals who do not meet the PAR-Q screening criteria for participation in moderate physical activity will be excluded from participating in this study
  • •women who are pregnant will be exclude from this study

研究组 & 干预措施

High density transcranial direct current stimulation (HD-tDCS)

Experimental

HD-tDCS (High-definition transcranial direct current stimulation) is a novel non-invasive brain stimulation (NIBS) technique based on the principle that when weak intensity electric currents are targeted on specific areas of the scalp, they cause underlying cortical stimulation.

干预措施: Cycling exercise at 65% of HRR for 20 minutes followed by HD-tDCS (exercise + HD-tDCS) (Other)

High density transcranial direct current stimulation (HD-tDCS)

Experimental

HD-tDCS (High-definition transcranial direct current stimulation) is a novel non-invasive brain stimulation (NIBS) technique based on the principle that when weak intensity electric currents are targeted on specific areas of the scalp, they cause underlying cortical stimulation.

干预措施: Cycling exercise at 65% of HRR exercise followed by sham HD-tDCS (exercise + sham tDCS) (Other)

High density transcranial direct current stimulation (HD-tDCS)

Experimental

HD-tDCS (High-definition transcranial direct current stimulation) is a novel non-invasive brain stimulation (NIBS) technique based on the principle that when weak intensity electric currents are targeted on specific areas of the scalp, they cause underlying cortical stimulation.

干预措施: No exercise followed by HD-tDCS (no exercise + HD-tDCS). (Other)

High density transcranial direct current stimulation (HD-tDCS)

Experimental

HD-tDCS (High-definition transcranial direct current stimulation) is a novel non-invasive brain stimulation (NIBS) technique based on the principle that when weak intensity electric currents are targeted on specific areas of the scalp, they cause underlying cortical stimulation.

干预措施: State Anxiety Inventory (Other)

High density transcranial direct current stimulation (HD-tDCS)

Experimental

HD-tDCS (High-definition transcranial direct current stimulation) is a novel non-invasive brain stimulation (NIBS) technique based on the principle that when weak intensity electric currents are targeted on specific areas of the scalp, they cause underlying cortical stimulation.

干预措施: Visual Analog Scale for Anxiety (Other)

结局指标

主要结局

Examine the anxiolytic effects of high density transcranial direct current stimulation (HD-tDCS) "primed" with physical activity (PA)

时间窗: Completion of 4 visits to research laboratory up to 15 days

Physical activity prior to HD-tDCS will enhance the anxiolytic effects beyond the benefits of physical activity alone and HD-tDCS alone. Thus, demonstrating a priming effect of PA on the anxiety alleviating electrical pathways that HD-tDCS activates at subthreshold level. Visual Analog Scale for Anxiety (VAS-Anxiety; rating from 0 = "not at all anxious" to 100 = "the most anxious I have ever felt") and three other scales assessing tingling, stiffness and numbness will be administered with a similar VAS

次要结局

  • Cerebral hemodynamics assessment(Completion of 4 visits to research laboratory up to 15 days)
  • HRV parameters will be acquired and calculated(Completion of 4 visits to research laboratory up to 15 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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