Major Depressive DisorderEmoStimNCT02793258
Impact of tDCS on Emotional Processing in Major Depression
A study testing transcranial direct current stimulation in people with Major Depressive Disorder, run by Hôpital le Vinatier at 1 site in France.
Trial summary
Background: transcranial direct current stimulation (tDCS) is an innovative treatment for major depression. However, its mechanisms of action are still unclear. Major depression is characterized by impaired processing of emotional information, which returns back to normal after successful antidepressant treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jul 2016to Dec 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy controls:
- Age between 18 and 65 years
- Given consent.
- Depressed subjects:
- Major depressive episode (no psychotic features) according to Diagnostic ans Statistical of Mental Disorders number 5 (DSM 5.0.)
- Age from 18-65
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- Antidepressant stable for the last 4 weeks
- MADRS ≥ 20.
- Given consent
Who cannot join
- Healthy controls:
- Psychiatric disorder
- Addiction except for tobacco addiction
- Ocular disease (except from refraction disorders), neurologic or cardiac disease.
- Neuroleptic or anticonvulsivant treatment
- Presence of a specific contraindication for tDCS (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker)
Show all 11Show fewer
- Depressed subjects:
- Other psychiatric disorder except for personality disorders
- Ocular disease (except from refraction disorders), neurologic or cardiac disease.
- Neuroleptic or anticonvulsivant treatment
- Presence of a specific contraindication for tDCS (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Transcranial Direct Current Stimulation on Emotional Processing in Major Depression
Background: transcranial direct current stimulation (tDCS) is an innovative treatment for major depression. However, its mechanisms of action are still unclear. Major depression is characterized by impaired processing of emotional information, which returns back to normal after successful antidepressant treatment. In this randomized double-blind study, the investigators aim to assess the effect of tDCS on emotional processing in major depression.
Read the detailed description
Methods: 40 subjects with major depression (20 active treatment and 20 placebo) will receive ten 30-minutes sessions of active two milliamps or sham tDCS (anode over left dorsolateral prefrontal cortex and cathode over right dorsolateral prefrontal cortex), twice a day for 5 consecutive days. Psychometric assessment of depression (MADRS,Beck Depression Inventory , CGI) and a neuropsychological assessment will be conducted before and after the treatment.
A facial emotion recognition task and an attentional emotional task with measurement of eye-tracking, heart rate, respiratory frequency and skin conductance will be conducted before and after the first session, and after the last session.
The investigators hypothesize that active tDCS will improve emotional processing in major depression, and that this will be observed after 1 and 10 sessions of tDCS.
Conclusions: Studying the impact of transcranial direct current stimulation on emotional processing in major depression could allow to better understand its antidepressant mechanisms
- Conditions
- Major Depressive Disorder
- Being tested
- transcranial direct current stimulation
- Keywords
- tDCS, neuromodulation, depression, cognition
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
Subjects will receive 10 30-minutes sessions of two milliamps transcranial direct current stimulation , twice a day for 5 consecutive day.
Facial emotion recognition task and attentional task with measurement of eye-tracking, heartrate, respiratory frequency and skin conductance will be conducted before and after the first session, and after the last session.
| Study group | Role | What they receive |
|---|---|---|
| Placebo tDCS | Placebo comparator | Subjects will receive 10 30-minutes sessions of sham tDCS, twice a day for 5 consecutive day.
Facial emotion recognition task and attentional task with measurement of eye-tracking, heartrate, respiratory frequency and skin conductance will be conducted before and after the first session, and after the last session. Receives: Device: transcranial direct current stimulation |
| Active tDCS | Experimental | receive 10 30-minutes sessions of two milliamps tDCS, twice a day for 5 consecutive day.
Stimulation will be performed using an tDCS stimulator with two 7×5 cm (35 cm2) sponge electrodes soaked in a saline solution (0.9% NaCl) Anode will be placed over the left dorsolateral prefrontal cortex (F3 according to the international EEG system) and cathode over the right dorsolateral prefrontal cortex (F4 according to the international EEG system) The twice daily sessions will be separated by at least 2 hours. Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of correct responses at a facial expression recognition task
A computerized facial expression recognition task was designed for the study. 240 pictures of emotional faces (8 identities, expressing anger, sadness, happiness, surprise, disgust, or fear, morphed with intensity of 20, 40, 50, 60 and 80%) are randomly displayed on a screen for 500ms. Subjects are asked to identify the emotion by answering on a keyboard.
Rate of correct responses is the main outcome. During this task, eye movements are recorded by an eye-tracking device. Skin conductance, respiratory and heart rate frequency are also recorded
Measured: within 5 days after stimulation
Secondary outcomes (9)
Evolution of the depressive symptoms measured by MADRS
Montgomery-Asberg Depression Rating Scale is a 10-item scale to evaluate the intensity of the depressive symptoms.
Measured: an average of two weeks
Performance on an attentional dot-probe task
Computerized "dot-probe " attentional task designed for the study. Pairs of emotional faces (neutral/sad ou neutral/happy) are randomly presented on a screen for 1000ms. Then, a probe is presented during 1100ms.subjects are asked to indicate a which side the probe approved During this task, eye movements are recorded by an eye-tracking device. Total time spent on Region of Interest (sad, happy or neutral face) is measured.
Skin conductance, respiratory and heart rate frequency are also recorded.
Measured: within 5 days after stimulation
tests of executive functions
Neuropsychological assessment : attentional functioning (TAP), executive functioning (BADS, working memory, go/no-go, stroop), memory (california verbal learning test) Improvement of executive functioning by tDCS will be assessed.
Measured: an average of two weeks
Beck depression inventory scale
Measured: within 5 days after stimulation
Clinical global impression scale
Measured: an average of two weeks
Eye movements during facial emotion recognition task and attentional task
Recorded by Eye tracker.Measurement of total time spent on specific Region of interest (eyes, nose, mouth, emotional face)
Measured: within 5 days after stimulation
Skin conductance measured in speed per microseconds
Recorded with physiologic data system (BIOPAC)
Measured: within 5 days after stimulation
Heart rate measured in number of heart pulses per milliseconds
Recorded with physiologic data system (BIOPAC)
Measured: within 5 days after stimulation
Respiratory frequency measured in number of respiratory cycles per minute
Recorded with physiologic data system(BIOPAC)
Measured: within 5 days after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study start22 Jul 2016
- Primary completion17 May 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HAESEBAERT FREDERIC, PH, Principal investigator, Centre Hospitalier le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793258
- Sponsor's protocol ID
- 2016-A00415-46
- Acronym
- EmoStim
- Status last verified
- Jan 2022
- First submitted
- 18 May 2016
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Transcranial Direct Current Stimulation on Emotional Processing in Major Depression
- ClinicalTrials.gov ID
- NCT02793258
- Acronym / sponsor ID
- EmoStim / 2016-A00415-46
- Conditions
- Major Depressive Disorder
- Keywords
- tDCS, neuromodulation, depression, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 22 Jul 2016 (actual)
- Primary completion
- 17 May 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 8 Jun 2016 (estimated)
- 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.
Background: transcranial direct current stimulation (tDCS) is an innovative treatment for major depression. However, its mechanisms of action are still unclear. Major depression is characterized by impaired processing of emotional information, which returns back to normal after successful antidepressant treatment. In this randomized double-blind study, the investigators aim to assess the effect of tDCS on emotional processing in major depression.
Detailed description
Methods: 40 subjects with major depression (20 active treatment and 20 placebo) will receive ten 30-minutes sessions of active two milliamps or sham tDCS (anode over left dorsolateral prefrontal cortex and cathode over right dorsolateral prefrontal cortex), twice a day for 5 consecutive days. Psychometric assessment of depression (MADRS,Beck Depression Inventory , CGI) and a neuropsychological assessment will be conducted before and after the treatment.
A facial emotion recognition task and an attentional emotional task with measurement of eye-tracking, heart rate, respiratory frequency and skin conductance will be conducted before and after the first session, and after the last session.
The investigators hypothesize that active tDCS will improve emotional processing in major depression, and that this will be observed after 1 and 10 sessions of tDCS.
Conclusions: Studying the impact of transcranial direct current stimulation on emotional processing in major depression could allow to better understand its antidepressant mechanisms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo tDCS | Placebo comparator | Device: transcranial direct current stimulationSubjects will receive 10 30-minutes sessions of sham tDCS, twice a day for 5 consecutive day. Facial emotion recognition task and attentional task with measurement of eye-tracking, heartrate, respiratory frequency and skin conductance will be conducted before and after the first session, and after the last session. |
| Active tDCS | Experimental | Device: transcranial direct current stimulationreceive 10 30-minutes sessions of two milliamps tDCS, twice a day for 5 consecutive day. Stimulation will be performed using an tDCS stimulator with two 7×5 cm (35 cm2) sponge electrodes soaked in a saline solution (0.9% NaCl) Anode will be placed over the left dorsolateral prefrontal cortex (F3 according to the international EEG system) and cathode over the right dorsolateral prefrontal cortex (F4 according to the international EEG system) The twice daily sessions will be separated by at least 2 hours. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 18 and 65 years
- Given consent.
- Major depressive episode (no psychotic features) according to Diagnostic ans Statistical of Mental Disorders number 5 (DSM 5.0.)
- Age from 18-65
- Antidepressant stable for the last 4 weeks
Key exclusion criteria (11 listed)
- Psychiatric disorder
- Addiction except for tobacco addiction
- Ocular disease (except from refraction disorders), neurologic or cardiac disease.
- Neuroleptic or anticonvulsivant treatment
- Presence of a specific contraindication for tDCS (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker)
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 stimulationSubjects will receive 10 30-minutes sessions of two milliamps transcranial direct current stimulation , twice a day for 5 consecutive day. Facial emotion recognition task and attentional task with measurement of eye-tracking, heartrate, respiratory frequency and skin conductance will be conducted before and after the first session, and after the last session. | Device | Active tDCS, Placebo tDCS |
Primary outcome
Number of correct responses at a facial expression recognition task
Time frame: within 5 days after stimulation
A computerized facial expression recognition task was designed for the study. 240 pictures of emotional faces (8 identities, expressing anger, sadness, happiness, surprise, disgust, or fear, morphed with intensity of 20, 40, 50, 60 and 80%) are randomly displayed on a screen for 500ms. Subjects are asked to identify the emotion by answering on a keyboard. Rate of correct responses is the main outcome. During this task, eye movements are recorded by an eye-tracking device. Skin conductance, respiratory and heart rate frequency are also recorded
9 secondary outcomes
Evolution of the depressive symptoms measured by MADRS
Time frame: an average of two weeks
Performance on an attentional dot-probe task
Time frame: within 5 days after stimulation
tests of executive functions
Time frame: an average of two weeks
Beck depression inventory scale
Time frame: within 5 days after stimulation
Clinical global impression scale
Time frame: an average of two weeks
Eye movements during facial emotion recognition task and attentional task
Time frame: within 5 days after stimulation
Skin conductance measured in speed per microseconds
Time frame: within 5 days after stimulation
Heart rate measured in number of heart pulses per milliseconds
Time frame: within 5 days after stimulation
Respiratory frequency measured in number of respiratory cycles per minute
Time frame: within 5 days after stimulation
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 27 Jan 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.
HAESEBAERT FREDERIC, PH principal investigator
Centre Hospitalier le Vinatier
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 in people with Major Depressive Disorder, run by Hôpital le Vinatier at 1 site in France.
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 9 inclusion and 11 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 27 Jan 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 France. 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?
Number of correct responses at a facial expression recognition task (time frame: within 5 days after stimulation). 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 27 Jan 2022.