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Completed

NCT Number: NCT04189354

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

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.

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Key information

Conditions

Anxiety Depression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Transcranial direct current stimulation (t-DCS) device

Device

t-DCS is a brain electrostimulation technique that consists of applying a current of low intensity (between 1 and 2 mA) on the scalp via two electrodes, in order to modify the cerebral activity of the stimulated zones. The investigators use the Soterix Medical t-DCS devices of the mini-CT 1x1 type.

Primary outcomes

  1. State-trait anxiety inventory (STAI-Y) scores

    Time frame: 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.

  2. State-trait anxiety inventory (STAI-Y) scores

    Time frame: 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.

  3. State-trait anxiety inventory (STAI-Y) scores

    Time frame: 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.

  4. State-trait anxiety inventory (STAI-Y) scores

    Time frame: 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.

Secondary outcomes

  1. Root mean square of successive differences (RMSSD)

    Time frame: Baseline (day 1)

    The Root Mean Square of the Successive Differences (RMSSD) is one of a few time-domain tools used to assess heart rate variability, the successive differences being neighboring RR intervals.

  2. Root mean square of successive differences (RMSSD)

    Time frame: Day 8

    The Root Mean Square of the Successive Differences (RMSSD) is one of a few time-domain tools used to assess heart rate variability, the successive differences being neighboring RR intervals.

  3. Root mean square of successive differences (RMSSD)

    Time frame: Day 29

    The Root Mean Square of the Successive Differences (RMSSD) is one of a few time-domain tools used to assess heart rate variability, the successive differences being neighboring RR intervals.

  4. Root mean square of successive differences (RMSSD)

    Time frame: One time point between day 60 and day 90

    The Root Mean Square of the Successive Differences (RMSSD) is one of a few time-domain tools used to assess heart rate variability, the successive differences being neighboring RR intervals.

  5. High frequency in spectral analysis

    Time frame: Baseline (day 1)

    Spectral analysis of the RR interval is an indirect, noninvasive measurement tool of heart rate variability. High-frequency RR signal (greater than 0.15 Hz) is associated with increased parasympathetic tone, and low-frequency RR signal (0.04-0.15 Hz) is associated with increased sympathetic tone.

  6. High frequency in spectral analysis

    Time frame: Day 8

    Spectral analysis of the RR interval is an indirect, noninvasive measurement tool of heart rate variability. High-frequency RR signal (greater than 0.15 Hz) is associated with increased parasympathetic tone, and low-frequency RR signal (0.04-0.15 Hz) is associated with increased sympathetic tone.

  7. High frequency in spectral analysis

    Time frame: Day 29

    Spectral analysis of the RR interval is an indirect, noninvasive measurement tool of heart rate variability. High-frequency RR signal (greater than 0.15 Hz) is associated with increased parasympathetic tone, and low-frequency RR signal (0.04-0.15 Hz) is associated with increased sympathetic tone.

  8. High frequency in spectral analysis

    Time frame: One time point between day 60 and day 90

    Spectral analysis of the RR interval is an indirect, noninvasive measurement tool of heart rate variability. High-frequency RR signal (greater than 0.15 Hz) is associated with increased parasympathetic tone, and low-frequency RR signal (0.04-0.15 Hz) is associated with increased sympathetic tone.

  9. Montgomery Asberg Depression Rating Scale (MADRS)

    Time frame: Baseline (day 1)

    The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. A total superior to 20/60 is generally considered abnormal. A level of 30 points is considered a definition of severe depression.

  10. Montgomery Asberg Depression Rating Scale (MADRS)

    Time frame: Day 8

    The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. A total superior to 20/60 is generally considered abnormal. A level of 30 points is considered a definition of severe depression.

  11. Montgomery Asberg Depression Rating Scale (MADRS)

    Time frame: Day 29

    The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. A total superior to 20/60 is generally considered abnormal. A level of 30 points is considered a definition of severe depression.

  12. Montgomery Asberg Depression Rating Scale (MADRS)

    Time frame: One time point between day 60 and day 90

    The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. A total superior to 20/60 is generally considered abnormal. A level of 30 points is considered a definition of severe depression.

Sponsors and collaborators

Lead sponsor

Tatiana Besse-Hammer

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 6, 2019
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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