Transfer Effects of Combined Attentional Filter Exercise and Transcranial Direct Current Stimulation

Healthy Clinical Trial

Official title:

Cognitive Transfer Effects on Working Memory and Higher Cognitive Functions by Combined Attentional Filter Exercise and tDCS in Healthy Younger Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03915483
• Other study ID #: MD021.1
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2019
• Source: German Center for Neurodegenerative Diseases (DZNE)
• Contact: Marlen Schmicker
• Phone: +49 3916724505
• Email: marlen.schmicker[@]dzne.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigation of how a single session of an attentional filter exercise of distractor inhibition combined with tDCS modulates cognitive functions like working memory, decision making and attentional control.

Description:

The study is designed as a between subject design with two groups defined by real or sham tDCS. The distractor inhibition exercise is conducted under either sham or real tDCS. Cognitive performance is assessed pre and post tDCS application, complemented by a short-termed follow-up on a consecutive day. Interindividual working memory capacity at baseline is taken into consideration.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• right-handed

• aged between 18 and 30 years

• normal or corrected to normal vision

• German-speaking

Exclusion Criteria:

• dyschromatopsia

• neurological or neuropsychiatric diseases

• low seizure threshold

• neurological medication

• metal implants in the head

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• transcranial direct current stimulation (tDCS)
sham or real tDCS for 10 minutes of 1.5 milliampere (mA) tDCS targeting the prefrontal and the posterior parietal cortex

Locations

Country	Name	City	State
Germany	German Center for Neurodegenerative Diseases	Magdeburg	Sachsen-Anhalt

Sponsors (1)

Lead Sponsor	Collaborator
German Center for Neurodegenerative Diseases (DZNE)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance change in computerized attentional filter exercise	attentional filtering performance (in % correct), effects of distractor interference for different set sizes	45 minutes on 1st day (pre) and on consecutive day (post)
Primary	Reaction change in computerized attentional filter exercise	reaction times (in milliseconds), effects of distractor interference for different set sizes	45 minutes on 1st day (pre) and on consecutive day (post)
Primary	Performance change in working memory and filtering performance	Working memory and filtering performance (in % correct), effects of distractor interference for different set sizes	30 minutes per pre-assessment, post assessment directly after intervention and short-termed follow-up on the consecutive day
Primary	Reaction change in working memory and filtering performance	reaction times (in milliseconds), effects of distractor interference for different set sizes	30 minutes per pre-assessment, post assessment directly after intervention and short-termed follow-up on the consecutive day
Secondary	Spatial Span	computerized spatial span forward and backward	10 minutes per pre-assessment and short-termed follow-up on the consecutive day
Secondary	Iowa Gambling Task	Decision making performance	7 minutes per pre-assessment, post assessment directly after intervention and short-termed follow-up on the consecutive day
Secondary	Trait-Anxiety	Assessment of trait anxiety via State-Trait-Anxiety-Inventory on first day	2 minutes on first day
Secondary	State-Anxiety	Daily assessment of state anxiety via State-Trait-Anxiety-Inventory at the beginning of each testing day	2 minutes on first and consecutive day
Secondary	Assessment of Sleep Quality	daily questionnaire assessing subjective rating of sleep of the previous night on 5- to 7-point Likert format and open questions (subjective quality of sleep, current fatigue, duration of sleep); no total score	10 minutes on first and consecutive day
Secondary	Daily Performance Questionnaires	self developed questionnaire assessing subjective performance in tested paradigms (5-point Likert format); no total or sub score; Question 1: How difficult would you rate the task? (lowest (1) = very difficult; highest (5) = very easy) Question 2: Do you think your performance changed in the course of the task? (lowest (1) = strongly worsened; highest (5) = strongly improved)	5 minutes on first and consecutive day
Secondary	Daily Strategy Questionnaires	reporting of used strategies in tested paradigms (open questions; subjects reported in written notes); self developed questionnaire for qualitative analyses of task demands; no scores; Question: Did you use a strategy? If so, please explain shortly.	5 minutes on first and consecutive day