Brief 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. 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

173

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.9 years study duration

Study Start

First participant enrolled

April 15, 2016

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2018

Completed

1.5 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2019

Completed

13 days until next milestone

First Posted

Study publicly available on registry

September 30, 2019

Completed

Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

1.9 years

First QC Date

September 17, 2019

Last Update Submit

September 27, 2019

Conditions

Cognitive Control

Keywords

Brain stimulationCognitive trainingCognitionCognitive enhancementTranscranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

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)).
2 to 14 weeks

Secondary Outcomes (2)

Affective state
2 weeks
Transfer effect
3 weeks

Study Arms (9)

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)