Supporting Cognitive Control Training With tDCS

NCT ID: NCT04108663

Last Updated: 2019-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-15

Study Completion Date

2018-03-26

Brief Summary

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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.

Detailed Description

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Conditions

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Cognitive Control

Keywords

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Brain stimulation Cognitive training Cognition Cognitive enhancement Transcranial direct current stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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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)

Group Type SHAM_COMPARATOR

Effect of tDCS on cognitive control task performance

Intervention Type BEHAVIORAL

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

L1A

Active tDCS

* laterality: left PFC (F3; second electrode placed on deltoid muscle of the opposing arm)
* intensity: of 1 mA
* polarity: anodal

Group Type ACTIVE_COMPARATOR

Effect of tDCS on cognitive control task performance

Intervention Type BEHAVIORAL

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

R1A

Active tDCS

* laterality: right PFC (F4; second electrode placed on deltoid muscle of the opposing arm)
* intensity: of 1 mA
* polarity: anodal

Group Type ACTIVE_COMPARATOR

Effect of tDCS on cognitive control task performance

Intervention Type BEHAVIORAL

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

L2A

Active tDCS

* laterality: left PFC (F3; second electrode placed on deltoid muscle of the opposing arm)
* intensity: of 2 mA
* polarity: anodal

Group Type ACTIVE_COMPARATOR

Effect of tDCS on cognitive control task performance

Intervention Type BEHAVIORAL

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

R2A

Active tDCS

* laterality: right PFC (F4; second electrode placed on deltoid muscle of the opposing arm)
* intensity: of 2 mA
* polarity: anodal

Group Type ACTIVE_COMPARATOR

Effect of tDCS on cognitive control task performance

Intervention Type BEHAVIORAL

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

L1C

Active tDCS

* laterality: left PFC (F3; second electrode placed on deltoid muscle of the opposing arm)
* intensity: of 1 mA
* polarity: cathodal

Group Type ACTIVE_COMPARATOR

Effect of tDCS on cognitive control task performance

Intervention Type BEHAVIORAL

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

R1C

Active tDCS

* laterality: right PFC (F4; second electrode placed on deltoid muscle of the opposing arm)
* intensity: of 1 mA
* polarity: cathodal

Group Type ACTIVE_COMPARATOR

Effect of tDCS on cognitive control task performance

Intervention Type BEHAVIORAL

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

L2C

Active tDCS

* laterality: left PFC (F3; second electrode placed on deltoid muscle of the opposing arm)
* intensity: of 2 mA
* polarity: cathodal

Group Type ACTIVE_COMPARATOR

Effect of tDCS on cognitive control task performance

Intervention Type BEHAVIORAL

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

R2C

Active tDCS

* laterality: right PFC (F4; second electrode placed on deltoid muscle of the opposing arm)
* intensity: of 2 mA
* polarity: cathodal

Group Type ACTIVE_COMPARATOR

Effect of tDCS on cognitive control task performance

Intervention Type BEHAVIORAL

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

Interventions

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Effect of tDCS on cognitive control task performance

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Christian Plewnia, MD

Doctor of Psychiatry and Psychotherapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Plewnia, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tübingen, Department of Psychiatry and Psychotherapy

Locations

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University of Tübingen, Department of Psychiatry and Psychotherapy

Tübingen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 37919761 (View on PubMed)

Weller 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.

Reference Type DERIVED
PMID: 32687899 (View on PubMed)

Other Identifiers

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GCBS-WP4

Identifier Type: -

Identifier Source: org_study_id