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临床试验/NCT04189354
NCT04189354已完成不适用

Study of the Synergistic Effects of Biofeedback and Transcranial Electrical Stimulation in Anxio-depressive Disorders

Tatiana Besse-Hammer1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2019年11月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
13
试验地点
1
主要终点
State-trait anxiety inventory (STAI-Y) scores

研究概览

简要总结

Anxio-depressive disorders are characterized by a difficulty in regulating the negative or aversive emotions adequately. These dysfunctions have been linked to a deficit in prefrontal cortex activity. The latter has an inhibitory influence on limbic regions -especially the amygdala- involved in the generation of emotions. By this means, the prefrontal cortex intervenes in the control of the sympathetic and parasympathetic branches of the autonomic nervous system whp are responsible for the physiological components of the emotion, including the variations of the cardiac rhythm (HRV: heart rate variability).

In emotionally demanding situations, the activity of the prefrontal cortex is generally associated with an increase in parasympathetic activity that is exerted by stimulation of the vagus nerve. In patients with anxio-depressive disorder, there is a decrease in the activity of the autonomic nervous system whose variability in heart rate is a recognized marker.

Many studies show a beneficial impact of transcranial direct current stimulation (t-DCS) on anxio-depressive symptoms, particularly when a particular area is targeted: the dorso-lateral prefrontal cortex. The impacts of this intervention are multiple and aim in particular to modulate the activity of the autonomic nervous system to promote regulation.

Biofeedback HRV is a technique that allows you to learn how to modulate your heart rate by means of respiratory control exercises. The patient receives an immediate feedback on the effectiveness of his learning (basic principle of bio-feedback). This intervention will allow to act on the parasympathetic activity and to promote a vagal tone adequate to the emotional regulation. Numerous studies have demonstrated the favorable impact of HRV biofeedback on the reduction of anxious and depressive symptoms.

Since the vagus nerve seems to be a primary pathway in physiologically emotional regulation, and considering that vagal tone can be stimulated by both the activity of the prefrontal cortex and through respiratory control, it appears interesting to study the association of t-DCS with HRV biofeedback techniques.

The first objective of this study is to show that HRV biofeedback training coupled with t-DCS is associated with a greater decrease in anxious symptomatology. The secondary objective of the study is to show that a coupling of these two techniques is associated with an increase of the variability of the cardiac rhythm as well as a more important decrease of the depressive symptomatology.

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
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • •Diagnose of anxio-depressive disorder
  • •Good understanding of French
  • •High anxiety level (STAI questionnaire score higher to 46) with reported difficulties to manage this anxiety.

排除标准

  • •Alcohol dependence (assessed by the AUDIT questionnaire)
  • •Pregnancy
  • •t-DCS contra indications : traumatic brain injury, epilepsy, known bipolar disease, electronic or metalic implant
  • •Known cardiac arrhythmia or intake of beta-blockers

研究组 & 干预措施

Active t-DCS

Experimental

Use of the t-DCS machine with the following stimulation parameters: current intensity of 2mA, electrode size of 25 cm2, duration of stimulation 20 minutes (excluding the fade-in and fade-out periods of 15 seconds).

干预措施: Transcranial direct current stimulation (t-DCS) device (Device)

Sham t-DCS

Sham Comparator

The condition of use in sham mode follows the same procedure as the active t-DCS except that the active stimulation lasts only 30 seconds at 3mA (60 seconds of active stimulation taking into account the periods of fade in and fade out).

The stimulator remains switched on during the procedure but does not deliver current. The devices are fully automatic and deliver an active or sham current according to a randomized stimulation code whose meaning is unknown by the operator, in order to respect the triple blind.

干预措施: Transcranial direct current stimulation (t-DCS) device (Device)

结局指标

主要结局

State-trait anxiety inventory (STAI-Y) scores

时间窗: One time point between day 60 and day 90

Questionnaire with 20 questions, each with 4 possible answers. Each answer corresponds to a score of 1 to 4, 1 indicating the lowest degree of anxiety and 4 the highest degree.

State-trait anxiety inventory (STAI-Y) scores

时间窗: Baseline (day 1)

Questionnaire with 20 questions, each with 4 possible answers. Each answer corresponds to a score of 1 to 4, 1 indicating the lowest degree of anxiety and 4 the highest degree.

State-trait anxiety inventory (STAI-Y) scores

时间窗: Day 8

Questionnaire with 20 questions, each with 4 possible answers. Each answer corresponds to a score of 1 to 4, 1 indicating the lowest degree of anxiety and 4 the highest degree.

State-trait anxiety inventory (STAI-Y) scores

时间窗: Day 29

Questionnaire with 20 questions, each with 4 possible answers. Each answer corresponds to a score of 1 to 4, 1 indicating the lowest degree of anxiety and 4 the highest degree.

次要结局

  • Root mean square of successive differences (RMSSD)(One time point between day 60 and day 90)
  • High frequency in spectral analysis(One time point between day 60 and day 90)
  • Montgomery Asberg Depression Rating Scale (MADRS)(One time point between day 60 and day 90)
  • Root mean square of successive differences (RMSSD)(Baseline (day 1))
  • Root mean square of successive differences (RMSSD)(Day 8)
  • Root mean square of successive differences (RMSSD)(Day 29)
  • High frequency in spectral analysis(Baseline (day 1))
  • High frequency in spectral analysis(Day 8)
  • High frequency in spectral analysis(Day 29)
  • Montgomery Asberg Depression Rating Scale (MADRS)(Baseline (day 1))
  • Montgomery Asberg Depression Rating Scale (MADRS)(Day 8)
  • Montgomery Asberg Depression Rating Scale (MADRS)(Day 29)

研究者

发起方
Tatiana Besse-Hammer
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tatiana Besse-Hammer

Head of clinical research unit

Brugmann University Hospital

研究点 (1)

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