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tDCS Effects on Associative Learning in Older Adults of Retirement Age (TRAINSTIM2)

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ClinicalTrials.gov Identifier: NCT02839993
Recruitment Status : Recruiting
First Posted : July 21, 2016
Last Update Posted : January 6, 2017
Sponsor:
Information provided by (Responsible Party):

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
Healthy Older Adults Device: tDCS Behavioral: training Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 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 Older Adults
Study Start Date : April 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 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 Name: 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 Name: 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. [ Time Frame: Performance is assessed within 1 day 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 [ Time Frame: assessed during baseline testing ]
    Connectivity as measured by resting-state fMRI during baseline as predictors for performance and tDCS responsiveness

  2. 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

  3. 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.

  4. Other cognitive outcomes: Attention performance [ Time Frame: Performance is assessed within 1 day before and 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 [ Time Frame: Performance is assessed within 1 day before and after tDCS + training compared to sham ]
    Digit span backwards performance assessed before and after stimulation to test for tDCS effects on working memory


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   66 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: old-retired (≥66 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

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): NCT02839993


Contacts
Contact: Agnes Flöel, Prof. Dr. 0049 30 450 560284 agnes.floeel@charite.de
Contact: Daria Antonenko, Dr. 0049 30 450 660 447 daria.antonenko@charite.de

Locations
Germany
Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Agnes Flöel, Prof.Dr.    0049 30 450 560284    agnes.floeel@charite.de   
Contact: Daria Antonenko, Dr.    0049 30 450 660 447    daria.amtonenko@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Agnes Flöel, Prof. Dr. Charite University, Berlin, Germany