NCT02839993

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 7, 2021

Status Verified

May 1, 2021

Enrollment Period

1.9 years

First QC Date

April 5, 2016

Last Update Submit

May 5, 2021

Conditions

Healthy Older Adults

Keywords

tDCS effectsassociative learning

Outcome Measures

Primary Outcomes (1)

  • Performance in a verbal associative learning paradigm under anodal tDCS compared to sham tDCS.

    Investigation whether anodal tDCS leads to improved performance accuracy in the Wernicko task compared to sham stimulation.

    Performance is assessed within 1 day immediately after training period (several learning blocks) compared to sham

Secondary Outcomes (5)

  • Functional connectivity predictors

    assessed during baseline testing

  • Structural predictors

    assessed during baseline testing

  • Genotyping of learning related polymorphisms

    assessed during baseline screening

  • Other cognitive outcomes: Attention performance

    Performance is assessed within 1 day before and after tDCS + training compared to sham

  • Other cognitive outcomes: working memory

    Performance is assessed within 1 day before and after tDCS + training compared to sham

Study Arms (2)

Anodal tDCS + training

EXPERIMENTAL

Combination of intensive training of picture-word associations (Wernicko task) with anodal stimulation

Device: tDCSBehavioral: training

Sham tDCS + training

SHAM COMPARATOR

Combination of intensive training of picture-word associations (Wernicko task) with sham stimulation

Device: tDCSBehavioral: training

Interventions

tDCSDEVICE
Anodal tDCS + trainingSham tDCS + training
trainingBEHAVIORAL
Also known as: intensive training of picture-word associations
Anodal tDCS + trainingSham tDCS + training

Eligibility Criteria

Age66 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age: old-retired (≥66 years).
  • Right handedness
  • unobtrusive neuropsychological screening

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (3)

  • 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.

    PMID: 18303984BACKGROUND

  • 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.

    PMID: 11856568BACKGROUND

  • 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.

    PMID: 15808996BACKGROUND

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Agnes Flöel, Prof. Dr.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

April 5, 2016

First Posted

July 21, 2016

Study Start

April 1, 2016

Primary Completion

March 1, 2018

Study Completion

May 1, 2018

Last Updated

May 7, 2021

Record last verified: 2021-05

Locations

DE(1)