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

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ClinicalTrials.gov Identifier: NCT03915483
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Notger Müller, German Center for Neurodegenerative Diseases (DZNE)

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Device: transcranial direct current stimulation (tDCS) Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cognitive Transfer Effects on Working Memory and Higher Cognitive Functions by Combined Attentional Filter Exercise and tDCS in Healthy Younger Adults
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: tDCS group
one session of computerized change detection attentional filter exercise (selective attention) combined with real tDCS
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

Sham Comparator: sham group
one session of computerized change detection attentional filter exercise (selective attention) combined with sham tDCS
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




Primary Outcome Measures :
  1. Performance change in computerized attentional filter exercise [ Time Frame: 45 minutes on 1st day (pre) and on consecutive day (post) ]
    attentional filtering performance (in % correct), effects of distractor interference for different set sizes

  2. Reaction change in computerized attentional filter exercise [ Time Frame: 45 minutes on 1st day (pre) and on consecutive day (post) ]
    reaction times (in milliseconds), effects of distractor interference for different set sizes

  3. Performance change in working memory and filtering performance [ Time Frame: 30 minutes per pre-assessment, post assessment directly after intervention and short-termed follow-up on the consecutive day ]
    Working memory and filtering performance (in % correct), effects of distractor interference for different set sizes

  4. Reaction change in working memory and filtering performance [ Time Frame: 30 minutes per pre-assessment, post assessment directly after intervention and short-termed follow-up on the consecutive day ]
    reaction times (in milliseconds), effects of distractor interference for different set sizes


Secondary Outcome Measures :
  1. Spatial Span [ Time Frame: 10 minutes per pre-assessment and short-termed follow-up on the consecutive day ]
    computerized spatial span forward and backward

  2. Iowa Gambling Task [ Time Frame: 7 minutes per pre-assessment, post assessment directly after intervention and short-termed follow-up on the consecutive day ]
    Decision making performance

  3. Trait-Anxiety [ Time Frame: 2 minutes on first day ]
    Assessment of trait anxiety via State-Trait-Anxiety-Inventory on first day

  4. State-Anxiety [ Time Frame: 2 minutes on first and consecutive day ]
    Daily assessment of state anxiety via State-Trait-Anxiety-Inventory at the beginning of each testing day

  5. Assessment of Sleep Quality [ Time Frame: 10 minutes on first and consecutive day ]
    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

  6. Daily Performance Questionnaires [ Time Frame: 5 minutes on first and consecutive day ]
    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)

  7. Daily Strategy Questionnaires [ Time Frame: 5 minutes on first and consecutive day ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915483


Contacts
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Contact: Marlen Schmicker +49 3916724505 marlen.schmicker@dzne.de

Locations
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Germany
German Center for Neurodegenerative Diseases Recruiting
Magdeburg, Sachsen-Anhalt, Germany, 39120
Contact: Marlen Schmicker         
Sponsors and Collaborators
German Center for Neurodegenerative Diseases (DZNE)
Investigators
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Principal Investigator: Notger Müller, Prof. Dr. German Center for Neurodegenerative Diseases (DZNE)
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Responsible Party: Notger Müller, Prof. Dr. med. (Head of Neuroprotection Lab at the DZNE), German Center for Neurodegenerative Diseases (DZNE)
ClinicalTrials.gov Identifier: NCT03915483    
Other Study ID Numbers: MD021.1
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No