Major DepressionNCT01652391
Modulation of Cognitive Control by Transcranial Direct Current Stimulation
A study testing Transcranial direct current stimulation (tDCS); DC-STIMULATOR (NeuroConn GmbH, Ilmenau, Germany) in people with Major Depression, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Insufficient cognitive control over emotional distracters is characteristic for major depressive disorder (MDD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) is associated with this deficit. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depression
- What is being tested?
- Transcranial direct current stimulation (tDCS); DC-STIMULATOR (NeuroConn GmbH, Ilmenau, Germany)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to Dec 2012
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age > 18
- informed consent
- in the patients group: Major depressive disorder, no antidepressant medication or stability over 1 week
Who cannot join
- seizures
- cardiac pacemaker
- deep brain stimulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modulation of Cognitive Control in Healthy and Depressed Subjects by Transcranial Direct Current Stimulation
Insufficient cognitive control over emotional distracters is characteristic for major depressive disorder (MDD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) is associated with this deficit. In this study the investigators assess the effect of an enhancement of dlPFC activity in MDD patients by anodal transcranial direct current stimulation (tDCS) on cognitive control.
In a double-blinded, balanced randomized, sham-controlled crossover trial the investigators determine the effect of a single-session tDCS to the left dlPFC on cognitive control in MDD patients and healthy controls. To assess the cognitive control the investigators use a delayed response working memory (DWM) task with pictures of varying valence presented during the delay period.
- Conditions
- Major Depression
- Being tested
- Transcranial direct current stimulation (tDCS); DC-STIMULATOR (NeuroConn GmbH, Ilmenau, Germany)
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (tDCS); DC-STIMULATOR (NeuroConn GmbH, Ilmenau, Germany)Device
| Study group | Role | What they receive |
|---|---|---|
| Anodal transcranial direct current stimulation | Experimental | Anodal transcranial direct current stimulation (tDCS) 20min, 1mA, F3 (EEG 10/20), reference right M. deltoideus Receives: Device: Transcranial direct current stimulation (tDCS); DC-STIMULATOR (NeuroConn GmbH, Ilmenau, Germany) |
| Sham transcranial direct current stimulation | Sham comparator | Sham transcranial direct current stimulation (tDCS) 40s, 1mA, F3 (EEG 10/20), reference right M. deltoideus Receives: Device: Transcranial direct current stimulation (tDCS); DC-STIMULATOR (NeuroConn GmbH, Ilmenau, Germany) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correctness of response
Measured: The primary outcome measure is obtained during the intervention (20min tDCS or sham stimulation).
Secondary outcomes (1)
Reaction time
Measured: The secondary outcome measure is obtained during the intervention (20min tDCS or sham stimulation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startJul 2011
- Primary completionJun 2012
- Study completionDec 2012
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 Major 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Plewnia, MD, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652391
- Sponsor's protocol ID
- 211/2010BO1_1
- Status last verified
- Dec 2013
- First submitted
- 23 Jul 2012
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Wolkenstein L, Plewnia C. Amelioration of cognitive control in depression by transcranial direct current stimulation. Biol Psychiatry. 2013 Apr 1;73(7):646-51. doi: 10.1016/j.biopsych.2012.10.010. Epub 2012 Dec 6.
PubMed 23219367
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Cognitive Control in Healthy and Depressed Subjects by Transcranial Direct Current Stimulation
- ClinicalTrials.gov ID
- NCT01652391
- Acronym / sponsor ID
- 211/2010BO1_1
- Conditions
- Major Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Jul 2012 (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.
Insufficient cognitive control over emotional distracters is characteristic for major depressive disorder (MDD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) is associated with this deficit. In this study the investigators assess the effect of an enhancement of dlPFC activity in MDD patients by anodal transcranial direct current stimulation (tDCS) on cognitive control.
In a double-blinded, balanced randomized, sham-controlled crossover trial the investigators determine the effect of a single-session tDCS to the left dlPFC on cognitive control in MDD patients and healthy controls. To assess the cognitive control the investigators use a delayed response working memory (DWM) task with pictures of varying valence presented during the delay period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal transcranial direct current stimulation | Experimental | Device: Transcranial direct current stimulation (tDCS); DC-STIMULATOR (NeuroConn GmbH, Ilmenau, Germany)Anodal transcranial direct current stimulation (tDCS) 20min, 1mA, F3 (EEG 10/20), reference right M. deltoideus |
| Sham transcranial direct current stimulation | Sham comparator | Device: Transcranial direct current stimulation (tDCS); DC-STIMULATOR (NeuroConn GmbH, Ilmenau, Germany)Sham transcranial direct current stimulation (tDCS) 40s, 1mA, F3 (EEG 10/20), reference right M. deltoideus |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18
- informed consent
- in the patients group: Major depressive disorder, no antidepressant medication or stability over 1 week
Key exclusion criteria (3 listed)
- seizures
- cardiac pacemaker
- deep brain stimulation
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 (tDCS); DC-STIMULATOR (NeuroConn GmbH, Ilmenau, Germany) | Device | Anodal transcranial direct current stimulation, Sham transcranial direct current stimulation |
Primary outcome
Correctness of response
Time frame: The primary outcome measure is obtained during the intervention (20min tDCS or sham stimulation).
1 secondary outcome
Reaction time
Time frame: The secondary outcome measure is obtained during the intervention (20min tDCS or sham 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 31 Dec 2013.
- Derived from this study: PubMed 23219367Wolkenstein L, Plewnia C. Amelioration of cognitive control in depression by transcranial direct current stimulation. Biol Psychiatry. 2013 Apr 1;73(7):646-51. doi: 10.1016/j.biopsych.2012.10.010. Epub 2012 Dec 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (tDCS); DC-STIMULATOR (NeuroConn GmbH, Ilmenau, Germany) in people with Major Depression, 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 3 inclusion and 3 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 31 Dec 2013. 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?
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?
Correctness of response (time frame: The primary outcome measure is obtained during the intervention (20min tDCS or sham stimulation).). 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 NCT01652391, 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 31 Dec 2013; AzTrials last refreshed its copy on 30 Oct 2026.