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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT02839993
First received: April 5, 2016
Last updated: January 5, 2017
Last verified: January 2017
  Purpose
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 Intervention Phase
Healthy Older Adults
Device: tDCS
Behavioral: training
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Effects of Transcranial Direct Current Stimulation (tDCS) on Associative Learning in Older Adults

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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:
  • 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

  • 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

  • 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.

  • 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

  • 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


Estimated Enrollment: 24
Study Start Date: April 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information