NCT03915483

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 10, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

9 months

First QC Date

April 8, 2019

Last Update Submit

April 15, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • 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)

  • 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)

  • 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

  • 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 Outcomes (7)

  • Spatial Span

    10 minutes per pre-assessment and short-termed follow-up on the consecutive day

  • Iowa Gambling Task

    7 minutes per pre-assessment, post assessment directly after intervention and short-termed follow-up on the consecutive day

  • Trait-Anxiety

    2 minutes on first day

  • State-Anxiety

    2 minutes on first and consecutive day

  • Assessment of Sleep Quality

    10 minutes on first and consecutive day

  • +2 more secondary outcomes

Study Arms (2)

tDCS group

EXPERIMENTAL

one session of computerized change detection attentional filter exercise (selective attention) combined with real tDCS

Device: transcranial direct current stimulation (tDCS)

sham group

SHAM COMPARATOR

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

Device: transcranial direct current stimulation (tDCS)

Interventions

transcranial direct current stimulation (tDCS)DEVICE

sham or real tDCS for 10 minutes of 1.5 milliampere (mA) tDCS targeting the prefrontal and the posterior parietal cortex

sham grouptDCS group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • right-handed
  • aged between 18 and 30 years
  • normal or corrected to normal vision
  • German-speaking

You may not qualify if:

  • dyschromatopsia
  • neurological or neuropsychiatric diseases
  • low seizure threshold
  • neurological medication
  • metal implants in the head

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Center for Neurodegenerative Diseases

Magdeburg, Saxony-Anhalt, 39120, Germany

RECRUITING

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Notger Müller, Prof. Dr.

    German Center for Neurodegenerative Diseases (DZNE)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marlen Schmicker

CONTACT

+49 3916724505marlen.schmicker@dzne.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. (Head of Neuroprotection Lab at the DZNE)

Study Record Dates

First Submitted

April 8, 2019

First Posted

April 16, 2019

Study Start

September 10, 2018

Primary Completion

June 1, 2019

Study Completion

December 31, 2019

Last Updated

April 16, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)