Cognitive ControlNCT04108663
Supporting Cognitive Control Training With tDCS
A study of Cognitive Control, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Cognitive control (CC) is an important prerequisite for goal-directed behaviour and often associated with dysfunctional prefrontal activity within the cortex. This can be ameliorated by non-invasive brain stimulation. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Control
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 173 participants
- Where
- 1 siteGermany
- Study dates
- 15 Apr 2016to 26 Mar 2018
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
- Right-handed (assessed by Edinburgh Handedness Inventory)
- No other concurrent brain stimulation during participation
- Proficient in German (min. CEFR level B)
- Ability to strictly adhere to study timeline
Who cannot join
- Diagnosed neurological illnesses
- Diagnosed psychiatric disorders
- Achromatopsia
- Metallic implants / tattoos on or near electrode sites
- Consumption of tobacco to an equivalent of ten or more cigarettes per day
- Prior participation in experiments involving the PASAT
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Tübingen, Department of Psychiatry and Psychotherapy
Tübingen, 72074
About this study
Official title: Lasting Amelioration of Deficient Cognitive Control by Transcranial Direct Current Stimulation (tDCS)-Enhanced Training
Cognitive control (CC) is an important prerequisite for goal-directed behaviour and often associated with dysfunctional prefrontal activity within the cortex. This can be ameliorated by non-invasive brain stimulation. In this randomised single-blind study we compare effects of transcranial direct current stimulation (tDCS) on CC in healthy subjects. The study includes 162 subjects who undergo a two-week (six sessions) training of cognitive control (adaptive paced auditory serial addition task, PASAT) supported by tDCS. Subjects are randomised to receive either concurrent anodal, cathodal, or sham tDCS with an intensity of 1 mA or 2 mA of their left (F3) or right (F4) PFC, resulting in eight stimulation groups. Stimulation effects on performance changes are compared to a sham control group.Changes in Affective state are measured by the positive and negative affect schedule (PANAS), possible transfer effects are assessed by the Eriksen Flanker task. Stability of effects is measured up to three months after the last intervention.
- Conditions
- Cognitive Control
- Being tested
- Effect of tDCS on cognitive control task performance
- Keywords
- Brain stimulation, Cognitive training, Cognition, Cognitive enhancement, Transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of tDCS on cognitive control task performanceBehavioural
Added verum or sham tDCS while working on a cognitive control task.
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | Sham tDCS (ramp up and ramp down of electrical current before as well as after task performance to elicit physical sensations similar to verum tDCS) Receives: Behavioral: Effect of tDCS on cognitive control task performance |
| L1A | Active comparator | Active tDCS
* laterality: left PFC (F3; second electrode placed on deltoid muscle of the opposing arm)
* intensity: of 1 mA
* polarity: anodal Receives: Behavioral: Effect of tDCS on cognitive control task performance |
| R1A | Active comparator | Active tDCS
* laterality: right PFC (F4; second electrode placed on deltoid muscle of the opposing arm)
* intensity: of 1 mA
* polarity: anodal Receives: Behavioral: Effect of tDCS on cognitive control task performance |
| L2A | Active comparator | Active tDCS
* laterality: left PFC (F3; second electrode placed on deltoid muscle of the opposing arm)
* intensity: of 2 mA
* polarity: anodal Receives: Behavioral: Effect of tDCS on cognitive control task performance |
| R2A | Active comparator | Active tDCS
* laterality: right PFC (F4; second electrode placed on deltoid muscle of the opposing arm)
* intensity: of 2 mA
* polarity: anodal Receives: Behavioral: Effect of tDCS on cognitive control task performance |
| L1C | Active comparator | Active tDCS
* laterality: left PFC (F3; second electrode placed on deltoid muscle of the opposing arm)
* intensity: of 1 mA
* polarity: cathodal Receives: Behavioral: Effect of tDCS on cognitive control task performance |
| R1C | Active comparator | Active tDCS
* laterality: right PFC (F4; second electrode placed on deltoid muscle of the opposing arm)
* intensity: of 1 mA
* polarity: cathodal Receives: Behavioral: Effect of tDCS on cognitive control task performance |
| L2C | Active comparator | Active tDCS
* laterality: left PFC (F3; second electrode placed on deltoid muscle of the opposing arm)
* intensity: of 2 mA
* polarity: cathodal Receives: Behavioral: Effect of tDCS on cognitive control task performance |
| R2C | Active comparator | Active tDCS
* laterality: right PFC (F4; second electrode placed on deltoid muscle of the opposing arm)
* intensity: of 2 mA
* polarity: cathodal Receives: Behavioral: Effect of tDCS on cognitive control task performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance
Changes in performance in the PASAT (as assessed by number of correct trials within each PASAT session) due to the various tDCS interventions. All eight interventions will be compared to the sham group. Cognitive performance is modified by tDCS, which is applied through a multi-channel stimulator (DC-Stimulator MC, NeuroConn GmbH, Ilmenau, Germany; software version 1.3.8; two rectangular rubber electrodes (5 x 7 cm)).
Measured: 2 to 14 weeks
Secondary outcomes (2)
Affective state
Changes in affective state over the course of the experiment (assessed by the positive and negative affect schedule (PANAS) questionnaire). Scores are calculated for negative and positive affect separately, by summing up the respective answers.
Measured: 2 weeks
Transfer effect
Transfer effects in the Eriksen Flanker task (assessed through mean reaction times). Means are calculated for congruent, incongruent, and neutral trials respectively.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start15 Apr 2016
- Primary completion26 Mar 2018
- Study completion26 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive ControlStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 173 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
- Investigators
- Christian Plewnia, MD, Principal investigator, University of Tübingen, Department of Psychiatry and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108663
- Sponsor's protocol ID
- GCBS-WP4
- Status last verified
- Sep 2019
- First submitted
- 17 Sep 2019
- Last updated
- 30 Sep 2019
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Weller S, Derntl B, Plewnia C. Sex matters for the enhancement of cognitive training with transcranial direct current stimulation (tDCS). Biol Sex Differ. 2023 Nov 2;14(1):78. doi: 10.1186/s13293-023-00561-4.
PubMed 37919761Weller S, Nitsche MA, Plewnia C. Enhancing cognitive control training with transcranial direct current stimulation: a systematic parameter study. Brain Stimul. 2020 Sep-Oct;13(5):1358-1369. doi: 10.1016/j.brs.2020.07.006. Epub 2020 Jul 18.
PubMed 32687899
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lasting Amelioration of Deficient Cognitive Control by Transcranial Direct Current Stimulation (tDCS)-Enhanced Training
- ClinicalTrials.gov ID
- NCT04108663
- Acronym / sponsor ID
- GCBS-WP4
- Conditions
- Cognitive Control
- Keywords
- Brain stimulation, Cognitive training, Cognition, Cognitive enhancement, Transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 15 Apr 2016 (actual)
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 26 Mar 2018 (actual)
- First posted
- 30 Sep 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.
Cognitive control (CC) is an important prerequisite for goal-directed behaviour and often associated with dysfunctional prefrontal activity within the cortex. This can be ameliorated by non-invasive brain stimulation. In this randomised single-blind study we compare effects of transcranial direct current stimulation (tDCS) on CC in healthy subjects. The study includes 162 subjects who undergo a two-week (six sessions) training of cognitive control (adaptive paced auditory serial addition task, PASAT) supported by tDCS. Subjects are randomised to receive either concurrent anodal, cathodal, or sham tDCS with an intensity of 1 mA or 2 mA of their left (F3) or right (F4) PFC, resulting in eight stimulation groups. Stimulation effects on performance changes are compared to a sham control group.Changes in Affective state are measured by the positive and negative affect schedule (PANAS), possible transfer effects are assessed by the Eriksen Flanker task. Stability of effects is measured up to three months after the last intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Sham | Sham comparator | Behavioral: Effect of tDCS on cognitive control task performanceSham tDCS (ramp up and ramp down of electrical current before as well as after task performance to elicit physical sensations similar to verum tDCS) |
| L1A | Active comparator | Behavioral: Effect of tDCS on cognitive control task performanceActive tDCS * laterality: left PFC (F3; second electrode placed on deltoid muscle of the opposing arm) * intensity: of 1 mA * polarity: anodal |
| R1A | Active comparator | Behavioral: Effect of tDCS on cognitive control task performanceActive tDCS * laterality: right PFC (F4; second electrode placed on deltoid muscle of the opposing arm) * intensity: of 1 mA * polarity: anodal |
| L2A | Active comparator | Behavioral: Effect of tDCS on cognitive control task performanceActive tDCS * laterality: left PFC (F3; second electrode placed on deltoid muscle of the opposing arm) * intensity: of 2 mA * polarity: anodal |
| R2A | Active comparator | Behavioral: Effect of tDCS on cognitive control task performanceActive tDCS * laterality: right PFC (F4; second electrode placed on deltoid muscle of the opposing arm) * intensity: of 2 mA * polarity: anodal |
| L1C | Active comparator | Behavioral: Effect of tDCS on cognitive control task performanceActive tDCS * laterality: left PFC (F3; second electrode placed on deltoid muscle of the opposing arm) * intensity: of 1 mA * polarity: cathodal |
| R1C | Active comparator | Behavioral: Effect of tDCS on cognitive control task performanceActive tDCS * laterality: right PFC (F4; second electrode placed on deltoid muscle of the opposing arm) * intensity: of 1 mA * polarity: cathodal |
| L2C | Active comparator | Behavioral: Effect of tDCS on cognitive control task performanceActive tDCS * laterality: left PFC (F3; second electrode placed on deltoid muscle of the opposing arm) * intensity: of 2 mA * polarity: cathodal |
| R2C | Active comparator | Behavioral: Effect of tDCS on cognitive control task performanceActive tDCS * laterality: right PFC (F4; second electrode placed on deltoid muscle of the opposing arm) * intensity: of 2 mA * polarity: cathodal |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy subjects
- Right-handed (assessed by Edinburgh Handedness Inventory)
- No other concurrent brain stimulation during participation
- Proficient in German (min. CEFR level B)
- Ability to strictly adhere to study timeline
Key exclusion criteria (6 listed)
- Diagnosed neurological illnesses
- Diagnosed psychiatric disorders
- Achromatopsia
- Metallic implants / tattoos on or near electrode sites
- Consumption of tobacco to an equivalent of ten or more cigarettes per day
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 |
|---|---|---|
| Effect of tDCS on cognitive control task performanceAdded verum or sham tDCS while working on a cognitive control task. | Behavioural | L1A, L1C, L2A, L2C, R1A, R1C, R2A, R2C, Sham |
Primary outcome
Cognitive performance
Time frame: 2 to 14 weeks
Changes in performance in the PASAT (as assessed by number of correct trials within each PASAT session) due to the various tDCS interventions. All eight interventions will be compared to the sham group. Cognitive performance is modified by tDCS, which is applied through a multi-channel stimulator (DC-Stimulator MC, NeuroConn GmbH, Ilmenau, Germany; software version 1.3.8; two rectangular rubber electrodes (5 x 7 cm)).
2 secondary outcomes
Affective state
Time frame: 2 weeks
Transfer effect
Time frame: 3 weeks
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 30 Sep 2019.
- Derived from this study: PubMed 37919761Weller S, Derntl B, Plewnia C. Sex matters for the enhancement of cognitive training with transcranial direct current stimulation (tDCS). Biol Sex Differ. 2023 Nov 2;14(1):78. doi: 10.1186/s13293-023-00561-4.
- Derived from this study: PubMed 32687899Weller S, Nitsche MA, Plewnia C. Enhancing cognitive control training with transcranial direct current stimulation: a systematic parameter study. Brain Stimul. 2020 Sep-Oct;13(5):1358-1369. doi: 10.1016/j.brs.2020.07.006. Epub 2020 Jul 18.
- Individual participant dataSharing planned: Undecided
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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.
Christian Plewnia, MD principal investigator
University of Tübingen, Department of Psychiatry and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cognitive Control, 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 5 inclusion and 6 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 30 Sep 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?
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?
Cognitive performance (time frame: 2 to 14 weeks). 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 NCT04108663, which also lists 2 linked publications.
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 30 Sep 2019.