TRAINSTIM2: tDCS Effects on Associative Learning in Younger Adults

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02795715
Collaborator
(none)
0
1
2
32
0

Study Details

Study Description

Brief Summary

The aim of this study is to investigate whether a tDCS-accompanied training of audio-visual associative memory leads to a performance improvement in healthy older individuals."

Condition or Disease Intervention/Treatment Phase
  • Device: tDCS
  • Behavioral: training
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effects of Transcranial Direct Current Stimulation (tDCS) on Associative Learning in Young Adults
Study Start Date :
Apr 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Anodal tDCS + training

Combination of intensive training of picture-word associations (Wernicko task) with anodal stimulation

Device: tDCS

Behavioral: training
Other Names:
  • intensive training of picture-word associations
  • Sham Comparator: Sham tDCS + training

    Combination of intensive training of picture-word associations (Wernicko task) with sham stimulation

    Device: tDCS

    Behavioral: training
    Other Names:
  • intensive training of picture-word associations
  • Outcome Measures

    Primary Outcome Measures

    1. Performance in a verbal associative learning paradigm under anodal tDCS compared to sham tDCS. [assessed immediately after training period (several learning blocks) compared to sham]

      Investigation whether anodal tDCS leads to improved performance accuracy in the Wernicko task compared to sham stimulation.

    Secondary Outcome Measures

    1. Functional connectivity predictors [assessed during baseline testing]

      Connectivity as measured by resting-state fMRI during baseline as predictors for performance and tDCS responsiveness

    2. Structural predictors [assessed during baseline testing]

      Microstructure of white matter (Fractional Anisotropy) as measured by diffusion tensor imaging during baseline as predictors for performance and tDCS responsiveness

    3. Genotyping of learning related polymorphisms [assessed during baseline screening]

      To assess predictors of positive reaction to brain stimulation, genotyping of several learning related polymorphisms will be performed

    4. Other cognitive outcomes: Attention performance [assessed directly before and immediately after tDCS + training compared to sham]

      Digit span forward performance assessed before and after stimulation to test for tDCS effects on attention

    5. Other cognitive outcomes: working memory performance [assessed directly before and immediately after tDCS + training compared to sham]

      Digit span backward performance assessed before and after stimulation to test for tDCS effects on working memory

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Age: young (18-30 years)

    • Right handedness

    • unobtrusive neuropsychological screening

    Exclusion Criteria:
    • Mild cognitive impairment (MCI) or other neurological diseases.

    • History of severe alcoholism or use of drugs.

    • Severe psychiatric disorders such as depression, psychosis (if not in remission) and severe untreated medical problems.

    • Contraindication for MRI (claustrophobia, metallic implants, ferromagnetic metals in the body, disorders of thermoregulation, pregnant women).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Charité Universitätsmedizin Berlin Berlin Germany 10117

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

    • Principal Investigator: Agnes Flöel, Prof. Dr., Charite University, Berlin, Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Agnes Flöel, Prof. Dr., Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT02795715
    Other Study ID Numbers:
    • TRAINSTIM2.C
    First Posted:
    Jun 10, 2016
    Last Update Posted:
    May 7, 2021
    Last Verified:
    May 1, 2021
    Keywords provided by Agnes Flöel, Prof. Dr., Charite University, Berlin, Germany

    Study Results

    No Results Posted as of May 7, 2021