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

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Completed
• CT.gov ID: NCT02795702
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arms: 2
• Actual Duration (Months): 13
• Patients Per Site Per Month: 1.1

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
Healthy Older Adults	Device: tDCS; Behavioral: training	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 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
• Actual Study Start Date: Apr 1, 2017
• Actual Primary Completion Date: Mar 1, 2018
• Actual Study Completion Date: May 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; 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

Outcome Measures

Primary Outcome Measures

1. Performance in a verbal associative learning paradigm under anodal tDCS compared to sham [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 outcome: Attention [assessed directly before and immediately after tDCS + training compared to]

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

5. Other cognitive outcome: Working memory [assessed directly before and immediately after tDCS + training compared to]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

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

• 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.
• 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.
• Flöel A, Rösser 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.

• Responsible Party: Agnes Flöel, Prof. Dr., Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT02795702
• Other Study ID Numbers: TRAINSTIM2.B
• First Posted: Jun 10, 2016
• Last Update Posted: May 7, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Agnes Flöel, Prof. Dr., Charite University, Berlin, Germany: tDCS

Study Results

No Results Posted as of May 7, 2021