Depression UnipolarNCT03518749
Effects of tDCS-enhanced Cognitive Control Training on Depression
A study testing 1mA tDCS and 2mA tDCS in people with Depression Unipolar, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Deficient cognitive control (CC) is one of the central characteristics of major depression (MD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) has been linked with this deficit. Antidepressants and cognitive-behavioral therapies modify CC most-likely as a common mechanism of treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression Unipolar
- What is being tested?
- 1mA tDCS and 2mA tDCS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteGermany
- Study dates
- 19 Mar 2018to 31 Dec 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- current Major Depressive Episode
- right handedness
Who cannot join
- history of seizures
- Intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
- pregnancy
- use of mood stabilizers
- diagnosed bipolar disorder
- current substance abuse (nicotine excluded)
Show all 11Show fewer
- current substance addiction (nicotine excluded)
- diagnosed psychotic diseases
- diagnosed anorexia nervosa
- diagnosed personality disorders: cluster A, antisocial personality disorder,
- borderline personality disorder
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, 72076
Christian Plewnia, Prof., MD, 0049 7071 29 86121, christian.plewnia@uni-tuebingen.de
Anja Sommer, M.Sc., 0049 7071 29 86127, anja.sommer@med.uni-tuebingen.de
About this study
Deficient cognitive control (CC) is one of the central characteristics of major depression (MD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) has been linked with this deficit. Antidepressants and cognitive-behavioral therapies modify CC most-likely as a common mechanism of treatment. Transcranial direct current stimulation (tDCS) is a safe, simple and effective non-invasive method to modulate the cortical excitability. It has been shown, that the activity of the dlPFC can be modulated by transcranial direct current stimulation (tDCS) with polarity-dependent learning-phase specific effects on performance that, when combined with training, can outlast the stimulation.
The goal of this randomized, sham-controlled, rater blind clinical trial is to investigate the effect of a tDCS-enhanced CC Training (CCT) on depressive symptom severity and compare the stimulation intensities 1mA, 2mA and sham tDCS. Overall, the study will include 57 participants (n = 19 per group). Each participant will complete 12 training sessions with online sham/ anodal tDCS.
Read more
As a training task we will use an adaptive version of the paced auditory serial addition task (PASAT). In the PASAT, digits are presented auditive and participants have to add the current digit to the digit they heard before. In the adaptive version the interstimulus-intervals decrease (increase) when four consecutive trials are correct (incorrect). The PASAT is known to elicit frustration. Participants have to exert cognitive control over these emotions to complete the task successfully.
Before, during and after the training symptom severity will be assessed. Baseline and post-training performance in the PASAT and in a transfer task (delayed working memory task, DWM) will be measured.
To further explore variables that influence the effect of tDCS on depressive symptom severity we will measure brain activity (EEG, NIRS), heart rate, global functioning (GAF), emotion regulation strategies, self-esteem, mood ratings and subjective performance ratings before and after the training and collect genetic factors.
Sustainability of the training effects will be measured at a follow-up visit (3 months later).
- Conditions
- Depression Unipolar
- Being tested
- 1mA tDCS, 2mA tDCS, Cognitive control training
- Keywords
- Depression, transcranial direct current stimulation (tDCS)
- 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.
1mA tDCSOther
transcranial direct current stimulation with the intensity of 1mA
2mA tDCSOther
transcranial direct current stimulation with the intensity of 2mA
Cognitive control trainingBehavioural
cognitive control training with the PASAT
| Study group | Role | What they receive |
|---|---|---|
| 1mA anodal tDCS + cognitive control training | Active comparator | 1 mA anodal tDCS will be administered to the left dlPFC (F3) for 23 mins during the performance of a cognitive control training. Receives: Other: 1mA tDCS; Behavioral: Cognitive control training |
| 2mA tDCS + cognitive control training | Active comparator | 2 mA anodal tDCS will be administered to the left dlPFC (F3) for 23 mins during the performance of a cognitive control training. Receives: Other: 2mA tDCS; Behavioral: Cognitive control training |
| sham tDCS + cognitive control training | Placebo comparator | Sham tDCS (30 secs of tDCS) will be administered to the left dlPFC (F3) with 2mA at the beginning of a cognitive control training. Receives: Behavioral: Cognitive control training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of MADRS scores
Change in Depressive Symptom severity will be measured with the Montgomery-Åsberg Depression Rating Scale (MADRS) from Baseline session to the last stimulation session, scale range from 0 to 60 points, higher scores indicate a more severe depression
Measured: Assessment one week before training start (week -1, day -5 on average) and in the last training session (week 4, day 26)
Secondary outcomes (13)
BDI scores
Beck Depression Inventory
Measured: Assessment one week before training start (week -1, day -5 on average), in the post training session (week 5, day 31 on average) and at follow-up (week 17, day 110 on average)
Number of correct trials in the PASAT
Performance in the PASAT. Number of correct trials.
Measured: Assessment one week before training start (week -1, day -5 on average), in the post training session (week 5, day 31 on average) and at follow-up (week 17, day 110 on average)
RT in the DWM
Reaction time in the transfer task, a delayed working memory task (DWM)
Measured: Assessment one week before training start (week -1, day -5 on average), in the post training session (week 5, day 31 on average) and at follow-up (week 17, day 110 on average)
Number of correct trials in the DWM
Number of correct trials in the transfer task, a delayed working memory task (DWM)
Measured: Assessment one week before training start (week -1, day -5 on average), in the post training session (week 5, day 31 on average) and at follow-up (week 17, day 110 on average)
GAF score
Global Assessment of Functioning
Measured: Assessment one week before training start (week -1, day -5 on average) and in the post training session (week 5, day 31 on average)
Delta Mood ratings
Mood changes (PANAS delta) through the PASAT performance: the positive and negative affective schedule (PANAS) will be conducted immediately before and after the PASAT performance. The change in mood ratings (PANAS delta = PANAS pre PASAT - PANAS post PASAT) will be the outcome measure.
Measured: Assessment one week before training start (week -1, day -5 on average), in the post training session (week 5, day 31 on average) and at follow-up (week 17, day 110 on average)
Subjective performance ratings
Participants will be asked to rate their performance and overall cognitive abilities on a likert scale.
Measured: Assessment one week before training start (week -1, day -5 on average), in the post training session (week 5, day 31 on average) and at follow-up (week 17, day 110 on average)
Electroencephalography (EEG) measures
EEG will be conducted to measure resting state oscillations and event related potentials stimulus locked to the presented feedback in the PASAT
Measured: Assessment one week before training start (week -1, day -5 on average) and in the post training session (week 5, day 31 on average)
Prefrontal Brain activity (NIRS)
Functional Near Infrared Spectroscopy will be used to measure frontal brain activity: resting state and during task performance.
Measured: Assessment one week before training start (week -1, day -5 on average) and in the post training session (week 5, day 31 on average)
Course of MADRS scores
Depressive Symptom severity will be measured with the Montgomery-Åsberg Depression Rating Scale
Measured: Assessment once a week during training (week 1, 2 and 3 at day 5, 12 and 19 respectively on average) and at the follow up visits (week 5 and 17, day 31 and 110 on average)
Prefrontal Brain activity (NIRS) as a predictor
The investigators will analyze if frontal brain activity measured with NIRS during resting state and task performance can contribute to the prediction of the effectiveness of the tDCS training.
Measured: Assessment one week before training start (week -1, day -5 on average)
Electroencephalography (EEG) measures as a predictor
The investigators will analyze if resting state oscillations and event related potentials stimulus locked to the presented feedback in the PASAT can contribute to the prediction of the effectiveness of the tDCS training.
Measured: Assessment one week before training start (week -1, day -5 on average)
Genetic factors as predictors
The investigators will analyze if genetic factors involved in neuroplasticity (5-HTTLPR, BDNF, COMT) can contribute to the prediction of the effectiveness of the tDCS training.
Measured: Assessment one week before training start (week -1, day -5 on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start19 Mar 2018
- Primary completion1 Oct 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression UnipolarStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, Universität Tübingen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518749
- Sponsor's protocol ID
- 01EE1403D-2
- Status last verified
- Feb 2019
- First submitted
- 13 Apr 2018
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sommer A, Fallgatter AJ, Plewnia C. Investigating mechanisms of cognitive control training: neural signatures of PASAT performance in depressed patients. J Neural Transm (Vienna). 2022 Jun;129(5-6):649-659. doi: 10.1007/s00702-021-02444-7. Epub 2021 Nov 23.
PubMed 34812928
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of tDCS-enhanced Cognitive Control Training on Depression
- ClinicalTrials.gov ID
- NCT03518749
- Acronym / sponsor ID
- 01EE1403D-2
- Conditions
- Depression Unipolar
- Keywords
- Depression, transcranial direct current stimulation (tDCS)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, Universität Tübingen
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 8 May 2018 (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.
Deficient cognitive control (CC) is one of the central characteristics of major depression (MD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) has been linked with this deficit. Antidepressants and cognitive-behavioral therapies modify CC most-likely as a common mechanism of treatment. Transcranial direct current stimulation (tDCS) is a safe, simple and effective non-invasive method to modulate the cortical excitability. It has been shown, that the activity of the dlPFC can be modulated by transcranial direct current stimulation (tDCS) with polarity-dependent learning-phase specific effects on performance that, when combined with training, can outlast the stimulation.
The goal of this randomized, sham-controlled, rater blind clinical trial is to investigate the effect of a tDCS-enhanced CC Training (CCT) on depressive symptom severity and compare the stimulation intensities 1mA, 2mA and sham tDCS. Overall, the study will include 57 participants (n = 19 per group). Each participant will complete 12 training sessions with online sham/ anodal tDCS.
As a training task we will use an adaptive version of the paced auditory serial addition task (PASAT). In the PASAT, digits are presented auditive and participants have to add the current digit to the digit they heard before. In the adaptive version the interstimulus-intervals decrease (increase) when four consecutive trials are correct (incorrect). The PASAT is known to elicit frustration. Participants have to exert cognitive control over these emotions to complete the task successfully.
Before, during and after the training symptom severity will be assessed. Baseline and post-training performance in the PASAT and in a transfer task (delayed working memory task, DWM) will be measured.
To further explore variables that influence the effect of tDCS on depressive symptom severity we will measure brain activity (EEG, NIRS), heart rate, global functioning (GAF), emotion regulation strategies, self-esteem, mood ratings and subjective performance ratings before and after the training and collect genetic factors.
Sustainability of the training effects will be measured at a follow-up visit (3 months later).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1mA anodal tDCS + cognitive control training | Active comparator | Other: 1mA tDCS, Behavioral: Cognitive control training1 mA anodal tDCS will be administered to the left dlPFC (F3) for 23 mins during the performance of a cognitive control training. |
| 2mA tDCS + cognitive control training | Active comparator | Other: 2mA tDCS, Behavioral: Cognitive control training2 mA anodal tDCS will be administered to the left dlPFC (F3) for 23 mins during the performance of a cognitive control training. |
| sham tDCS + cognitive control training | Placebo comparator | Behavioral: Cognitive control trainingSham tDCS (30 secs of tDCS) will be administered to the left dlPFC (F3) with 2mA at the beginning of a cognitive control training. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- current Major Depressive Episode
- right handedness
Key exclusion criteria (11 listed)
- history of seizures
- Intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
- pregnancy
- use of mood stabilizers
- diagnosed bipolar disorder
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 |
|---|---|---|
| 1mA tDCStranscranial direct current stimulation with the intensity of 1mA | Other | 1mA anodal tDCS + cognitive control training |
| 2mA tDCStranscranial direct current stimulation with the intensity of 2mA | Other | 2mA tDCS + cognitive control training |
| Cognitive control trainingcognitive control training with the PASAT | Behavioural | 1mA anodal tDCS + cognitive control training, 2mA tDCS + cognitive control training, sham tDCS + cognitive control training |
Primary outcome
Change of MADRS scores
Time frame: Assessment one week before training start (week -1, day -5 on average) and in the last training session (week 4, day 26)
Change in Depressive Symptom severity will be measured with the Montgomery-Åsberg Depression Rating Scale (MADRS) from Baseline session to the last stimulation session, scale range from 0 to 60 points, higher scores indicate a more severe depression
13 secondary outcomes
BDI scores
Time frame: Assessment one week before training start (week -1, day -5 on average), in the post training session (week 5, day 31 on average) and at follow-up (week 17, day 110 on average)
Number of correct trials in the PASAT
Time frame: Assessment one week before training start (week -1, day -5 on average), in the post training session (week 5, day 31 on average) and at follow-up (week 17, day 110 on average)
RT in the DWM
Time frame: Assessment one week before training start (week -1, day -5 on average), in the post training session (week 5, day 31 on average) and at follow-up (week 17, day 110 on average)
Number of correct trials in the DWM
Time frame: Assessment one week before training start (week -1, day -5 on average), in the post training session (week 5, day 31 on average) and at follow-up (week 17, day 110 on average)
GAF score
Time frame: Assessment one week before training start (week -1, day -5 on average) and in the post training session (week 5, day 31 on average)
Delta Mood ratings
Time frame: Assessment one week before training start (week -1, day -5 on average), in the post training session (week 5, day 31 on average) and at follow-up (week 17, day 110 on average)
Subjective performance ratings
Time frame: Assessment one week before training start (week -1, day -5 on average), in the post training session (week 5, day 31 on average) and at follow-up (week 17, day 110 on average)
Electroencephalography (EEG) measures
Time frame: Assessment one week before training start (week -1, day -5 on average) and in the post training session (week 5, day 31 on average)
Prefrontal Brain activity (NIRS)
Time frame: Assessment one week before training start (week -1, day -5 on average) and in the post training session (week 5, day 31 on average)
Course of MADRS scores
Time frame: Assessment once a week during training (week 1, 2 and 3 at day 5, 12 and 19 respectively on average) and at the follow up visits (week 5 and 17, day 31 and 110 on average)
Prefrontal Brain activity (NIRS) as a predictor
Time frame: Assessment one week before training start (week -1, day -5 on average)
Electroencephalography (EEG) measures as a predictor
Time frame: Assessment one week before training start (week -1, day -5 on average)
Genetic factors as predictors
Time frame: Assessment one week before training start (week -1, day -5 on average)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Derived from this study: PubMed 34812928Sommer A, Fallgatter AJ, Plewnia C. Investigating mechanisms of cognitive control training: neural signatures of PASAT performance in depressed patients. J Neural Transm (Vienna). 2022 Jun;129(5-6):649-659. doi: 10.1007/s00702-021-02444-7. Epub 2021 Nov 23.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1mA tDCS and 2mA tDCS in people with Depression Unipolar, run by University Hospital Tuebingen at 1 site in Germany.
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 2 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: status not confirmed, as of the sponsor's last update on 19 Feb 2019. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Plewnia, MD (+49 (0)7071-2986121, christian.plewnia@uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of MADRS scores (time frame: Assessment one week before training start (week -1, day -5 on average) and in the last training session (week 4, day 26)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03518749, which also lists 1 linked publication.
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 Feb 2019.