Supporting Cognitive Control Training With tDCS
September 27, 2019 updated by: Christian Plewnia, MD, University Hospital Tuebingen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
173
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tübingen, Germany, 72074
- University of Tübingen, Department of Psychiatry and Psychotherapy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Sham
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)
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Added verum or sham tDCS while working on a cognitive control task.
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Active Comparator: L1A
Active tDCS
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Added verum or sham tDCS while working on a cognitive control task.
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Active Comparator: R1A
Active tDCS
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Added verum or sham tDCS while working on a cognitive control task.
|
|
Active Comparator: L2A
Active tDCS
|
Added verum or sham tDCS while working on a cognitive control task.
|
|
Active Comparator: R2A
Active tDCS
|
Added verum or sham tDCS while working on a cognitive control task.
|
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Active Comparator: L1C
Active tDCS
|
Added verum or sham tDCS while working on a cognitive control task.
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Active Comparator: R1C
Active tDCS
|
Added verum or sham tDCS while working on a cognitive control task.
|
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Active Comparator: L2C
Active tDCS
|
Added verum or sham tDCS while working on a cognitive control task.
|
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Active Comparator: R2C
Active tDCS
|
Added verum or sham tDCS while working on a cognitive control task.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive performance
Time Frame: 2 to 14 weeks
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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 to 14 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Affective state
Time Frame: 2 weeks
|
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.
|
2 weeks
|
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Transfer effect
Time Frame: 3 weeks
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Transfer effects in the Eriksen Flanker task (assessed through mean reaction times).
Means are calculated for congruent, incongruent, and neutral trials respectively.
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3 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christian Plewnia, MD, University of Tübingen, Department of Psychiatry and Psychotherapy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2016
Primary Completion (Actual)
March 26, 2018
Study Completion (Actual)
March 26, 2018
Study Registration Dates
First Submitted
September 17, 2019
First Submitted That Met QC Criteria
September 27, 2019
First Posted (Actual)
September 30, 2019
Study Record Updates
Last Update Posted (Actual)
September 30, 2019
Last Update Submitted That Met QC Criteria
September 27, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GCBS-WP4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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