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Completed

NCT Number: NCT04108663

Supporting Cognitive Control Training With tDCS

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.

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Key information

Conditions

Cognitive Control

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tübingen, Department of Psychiatry and Psychotherapy

Tübingen, 72074, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Effect of tDCS on cognitive control task performance

Behavioral

Added verum or sham tDCS while working on a cognitive control task.

Primary outcomes

  1. 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)).

Secondary outcomes

  1. 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. Transfer effect

    Time frame: 3 weeks

    Transfer effects in the Eriksen Flanker task (assessed through mean reaction times). Means are calculated for congruent, incongruent, and neutral trials respectively.

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Lasting Amelioration of Deficient Cognitive Control by Transcranial Direct Current Stimulation (tDCS)-Enhanced Training

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 30, 2019
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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