tDCS Effects on Associative Learning in Younger Adults (TRAINSTIM2)

May 5, 2021 updated by: Agnes Flöel, Charite University, Berlin, Germany

Effects of Transcranial Direct Current Stimulation (tDCS) on Associative Learning in Young Adults

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."

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance in a verbal associative learning paradigm under anodal tDCS compared to sham tDCS.
Time Frame: 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.
assessed immediately after training period (several learning blocks) compared to sham

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional connectivity predictors
Time Frame: assessed during baseline testing
Connectivity as measured by resting-state fMRI during baseline as predictors for performance and tDCS responsiveness
assessed during baseline testing
Structural predictors
Time Frame: 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
assessed during baseline testing
Genotyping of learning related polymorphisms
Time Frame: assessed during baseline screening
To assess predictors of positive reaction to brain stimulation, genotyping of several learning related polymorphisms will be performed
assessed during baseline screening
Other cognitive outcomes: Attention performance
Time Frame: 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
assessed directly before and immediately after tDCS + training compared to sham
Other cognitive outcomes: working memory performance
Time Frame: 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
assessed directly before and immediately after tDCS + training compared to sham

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

June 6, 2016

First Posted (Estimate)

June 10, 2016

Study Record Updates

Last Update Posted (Actual)

May 7, 2021

Last Update Submitted That Met QC Criteria

May 5, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TRAINSTIM2.C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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