Anxiety DepressionNCT04189354
Study of the Synergistic Effects of Biofeedback and Transcranial Electrical Stimulation in Anxio-depressive Disorders
A study testing Transcranial direct current stimulation (t-DCS) device in people with Anxiety Depression, run by Tatiana Besse-Hammer at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Depression
- What is being tested?
- Transcranial direct current stimulation (t-DCS) device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Nov 2019to 23 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Anxiety Depression
- Being tested
- Transcranial direct current stimulation (t-DCS) device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (t-DCS) deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Transcranial direct current stimulation (t-DCS) 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. Receives: Device: Transcranial direct current stimulation (t-DCS) device |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-trait anxiety inventory (STAI-Y) scores
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.
Measured: Baseline (day 1)
State-trait anxiety inventory (STAI-Y) scores
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.
Measured: Day 8
State-trait anxiety inventory (STAI-Y) scores
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.
Measured: Day 29
State-trait anxiety inventory (STAI-Y) scores
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.
Measured: One time point between day 60 and day 90
Secondary outcomes (12)
Root mean square of successive differences (RMSSD)
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.
Measured: Baseline (day 1)
Root mean square of successive differences (RMSSD)
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.
Measured: Day 8
Root mean square of successive differences (RMSSD)
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.
Measured: Day 29
Root mean square of successive differences (RMSSD)
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.
Measured: One time point between day 60 and day 90
High frequency in spectral analysis
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.
Measured: Baseline (day 1)
High frequency in spectral analysis
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.
Measured: Day 8
High frequency in spectral analysis
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.
Measured: Day 29
High frequency in spectral analysis
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.
Measured: One time point between day 60 and day 90
Montgomery Asberg Depression Rating Scale (MADRS)
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.
Measured: Baseline (day 1)
Montgomery Asberg Depression Rating Scale (MADRS)
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.
Measured: Day 8
Montgomery Asberg Depression Rating Scale (MADRS)
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.
Measured: Day 29
Montgomery Asberg Depression Rating Scale (MADRS)
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.
Measured: One time point between day 60 and day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start12 Nov 2019
- Primary completion23 Jun 2021
- Study completion23 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tatiana Besse-Hammer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tatiana Besse-Hammer, Brugmann University Hospital
- Investigators
- Pierre Cole, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189354
- Sponsor's protocol ID
- CHUB-PSY-COMBINTES 1
- Status last verified
- Jul 2022
- First submitted
- 3 Dec 2019
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Synergistic Effects of Biofeedback and Transcranial Electrical Stimulation in Anxio-depressive Disorders
- ClinicalTrials.gov ID
- NCT04189354
- Acronym / sponsor ID
- CHUB-PSY-COMBINTES 1
- Conditions
- Anxiety Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Tatiana Besse-HammerUniversity, hospital or other
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 23 Jun 2021 (actual)
- Study completion
- 23 Jun 2021 (actual)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active t-DCS | Experimental | Device: Transcranial direct current stimulation (t-DCS) deviceUse 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). |
| Sham t-DCS | Sham comparator | Device: Transcranial direct current stimulation (t-DCS) deviceThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulation (t-DCS) devicet-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. | Device | Active t-DCS, Sham t-DCS |
Primary outcome
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.
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.
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.
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.
12 secondary outcomes
Root mean square of successive differences (RMSSD)
Time frame: Baseline (day 1)
Root mean square of successive differences (RMSSD)
Time frame: Day 8
Root mean square of successive differences (RMSSD)
Time frame: Day 29
Root mean square of successive differences (RMSSD)
Time frame: One time point between day 60 and day 90
High frequency in spectral analysis
Time frame: Baseline (day 1)
High frequency in spectral analysis
Time frame: Day 8
High frequency in spectral analysis
Time frame: Day 29
High frequency in spectral analysis
Time frame: One time point between day 60 and day 90
Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: Baseline (day 1)
Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: Day 8
Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: Day 29
Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: One time point between day 60 and day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Cole principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation (t-DCS) device in people with Anxiety Depression, run by Tatiana Besse-Hammer at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-trait anxiety inventory (STAI-Y) scores (time frame: Baseline (day 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.