DepressionNCT01903538
Interference With Cognitive Control by Transcranial Direct Current Stimulation
A study testing Cathodal transcranial direct current stimulation (tDCS) in people with 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 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Cathodal transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to Jul 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- informed consent
Who cannot join
- psychiatric or neurological disorders seizures cardiac pacemakers
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy, University of Tübingen
Tübingen, 72076
About this study
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 a decrease of dlPFC activity in healthy subjects by cathodal 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 of cathodal tDCS to the left dlPFC on cognitive control in healthy subjects. To assess the cognitive control the investigators use a delayed response working memory task (DWM)and an arithmetic inhibition task (AIT) with pictures of varying valence.
- Conditions
- Depression
- Being tested
- Cathodal transcranial direct current stimulation (tDCS), Sham transcranial direct current stimulation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cathodal transcranial direct current stimulation (tDCS)Device
Cathodal transcranial direct current stimulation (tDCS) 20min, 1mA, F3 (EEG 10/20), reference right M. deltoideus
Sham transcranial direct current stimulationDevice
Sham transcranial direct current stimulation (tDCS) 40s, 1mA, F3 (EEG 10/20), reference right M. deltoideus
| Study group | Role | What they receive |
|---|---|---|
| Cathodal transcranial direct current stimulation | Experimental | Not described Receives: Device: Cathodal transcranial direct current stimulation (tDCS) |
| Sham transcranial direct current stimulation | Sham comparator | Not described Receives: Device: Sham transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correctness and reaction time of response
Correctness is defined as the percentage of correct responses in the DWM and AIT
Measured: Within 30 min starting 5 min after the initiation of stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startJul 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 28 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
- NCT01903538
- Sponsor's protocol ID
- 211/2010BO1_2
- Status last verified
- Jul 2013
- First submitted
- 13 Jul 2013
- Last updated
- 19 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interference With Cognitive Control by Transcranial Direct Current Stimulation
- ClinicalTrials.gov ID
- NCT01903538
- Acronym / sponsor ID
- 211/2010BO1_2
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 19 Jul 2013 (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 a decrease of dlPFC activity in healthy subjects by cathodal 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 of cathodal tDCS to the left dlPFC on cognitive control in healthy subjects. To assess the cognitive control the investigators use a delayed response working memory task (DWM)and an arithmetic inhibition task (AIT) with pictures of varying valence.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cathodal transcranial direct current stimulation | Experimental | Device: Cathodal transcranial direct current stimulation (tDCS) |
| Sham transcranial direct current stimulation | Sham comparator | Device: Sham transcranial direct current stimulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- informed consent
Key exclusion criteria (1 listed)
- psychiatric or neurological disorders seizures cardiac pacemakers
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 |
|---|---|---|
| Cathodal transcranial direct current stimulation (tDCS)Cathodal transcranial direct current stimulation (tDCS) 20min, 1mA, F3 (EEG 10/20), reference right M. deltoideus | Device | Cathodal transcranial direct current stimulation |
| Sham transcranial direct current stimulationSham transcranial direct current stimulation (tDCS) 40s, 1mA, F3 (EEG 10/20), reference right M. deltoideus | Device | Sham transcranial direct current stimulation |
Primary outcome
Correctness and reaction time of response
Time frame: Within 30 min starting 5 min after the initiation of stimulation
Correctness is defined as the percentage of correct responses in the DWM and AIT
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 2013.
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Survivorship
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 Cathodal transcranial direct current stimulation (tDCS) in people with 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 1 inclusion and 1 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 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 and reaction time of response (time frame: Within 30 min starting 5 min after the initiation of 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 19 Jul 2013.