Supporting Cognitive Control Training With tDCS

Cognitive Control Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04108663
• Other study ID #: GCBS-WP4
• Status: Completed
• Phase: N/A
• Start date: April 15, 2016
• Est. completion date: March 26, 2018

Study information

• Verified date: September 2019
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: March 26, 2018
• Est. primary completion date: March 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Control

Intervention

Behavioral:
• Effect of tDCS on cognitive control task performance
Added verum or sham tDCS while working on a cognitive control task.

Locations

Country	Name	City	State
Germany	University of Tübingen, Department of Psychiatry and Psychotherapy	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	2 weeks
Secondary	Transfer effect	Transfer effects in the Eriksen Flanker task (assessed through mean reaction times). Means are calculated for congruent, incongruent, and neutral trials respectively.	3 weeks