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

Effects of Transcranial Direct Current Stimulation (tDCS) on Associative Learning in Older 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: Completed
• Conditions: Healthy Older Adults
• Intervention / Treatment: Device: tDCS; Behavioral: training

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charite Universitatsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age: older in working age (50-65 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

How is the study designed?

Design Details

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

Number of Arms

2

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; Transcranial direct current stimulation; Behavioral: training; Cognitive 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; Transcranial direct current stimulation; Behavioral: training; Cognitive 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	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	Connectivity as measured by resting-state fMRI during baseline as predictors for performance and tDCS responsiveness	assessed during baseline testing
Structural predictors	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	To assess predictors of positive reaction to brain stimulation, genotyping of several learning related polymorphisms will be performed	: assessed during baseline screening
Other cognitive outcome: Attention	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
Other cognitive outcome: Working memory	Digit span backwards performance assessed before and after stimulation to test for tDCS effects on working memory	assessed directly before and immediately after tDCS + training compared to

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Publications and helpful links

General Publications

• Floel A, Rosser N, Michka O, Knecht S, Breitenstein C. Noninvasive brain stimulation improves language learning. J Cogn Neurosci. 2008 Aug;20(8):1415-22. doi: 10.1162/jocn.2008.20098.
• Breitenstein C, Knecht S. Development and validation of a language learning model for behavioral and functional-imaging studies. J Neurosci Methods. 2002 Mar 15;114(2):173-9. doi: 10.1016/s0165-0270(01)00525-8.
• Breitenstein C, Jansen A, Deppe M, Foerster AF, Sommer J, Wolbers T, Knecht S. Hippocampus activity differentiates good from poor learners of a novel lexicon. Neuroimage. 2005 Apr 15;25(3):958-68. doi: 10.1016/j.neuroimage.2004.12.019.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): May 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: tDCS
• Other Study ID Numbers: TRAINSTIM2.B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No