NCT02110056

Brief Summary

The aim of this study is to investigate whether a combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS) leads to an improvement of learning and memory in healthy older adults and to examine the underlying neuronal mechanism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

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

First Submitted

Initial submission to the registry

February 13, 2014

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 10, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

1.7 years

First QC Date

February 13, 2014

Last Update Submit

January 29, 2018

Conditions

Healthy Older Adults

Keywords

healthy older adultstDCSLOCATO taskvisual-spatial learning

Outcome Measures

Primary Outcomes (1)

  • Performance in LOCATO task (Visual-Spatial learning and memory) after a combination of intensive visual-spatial training and tDCS

    Investigation whether the combination of intensive visual-spatial training (LOCATO task) and tDCS leads to an improvement of visual-spatial learning and memory measured by performance in LOCATO task after end of a 3 day training period compared to sham stimulation.

    immediately after the end of a 3 day training period in tDCS condition compared to sham condition

Secondary Outcomes (7)

  • long term effects

    after 1 month vs baseline

  • functional changes: Connectivity

    after end of 3-day period of training vs baseline

  • cortical excitability

    at baseline

  • Quality of life

    after 1 month vs baseline

  • memory

    immediately after end of 3-day of cognitive training, after 1 month vs. baseline

  • +2 more secondary outcomes

Study Arms (2)

training + tDCS

EXPERIMENTAL

Combination of intensive training of visual-spatial abilities (LOCATO task) with transcranial direct current stimulation (tDCS)

Device: tDCSBehavioral: training

training + sham stimulation

SHAM COMPARATOR

Combination of intensive training of visual-spatial abilities (LOCATO task) with sham stimulation

Device: tDCSBehavioral: training

Interventions

tDCSDEVICE

transcranial direct current stimulation (tDCS)

training + sham stimulationtraining + tDCS
trainingBEHAVIORAL

intensive training of visual-spatial abilities (in LOCATO task)

training + sham stimulationtraining + tDCS

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • right handedness
  • unobtrusive neuropsychological screening
  • age: 50-90 years

You may not qualify if:

  • severe internal or psychiatric disease
  • epilepsy
  • other severe neurological diseases, e.g. previous major stroke or brain tumor
  • DMS-IV manifest dementia
  • contraindication for MRT (claustrophobia, metallic implants, tattoos)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (2)

  • Antonenko D, Kulzow N, Cesarz ME, Schindler K, Grittner U, Floel A. Hippocampal Pathway Plasticity Is Associated with the Ability to Form Novel Memories in Older Adults. Front Aging Neurosci. 2016 Mar 22;8:61. doi: 10.3389/fnagi.2016.00061. eCollection 2016.

    PMID: 27047376RESULT

  • Antonenko D, Kulzow N, Sousa A, Prehn K, Grittner U, Floel A. Neuronal and behavioral effects of multi-day brain stimulation and memory training. Neurobiol Aging. 2018 Jan;61:245-254. doi: 10.1016/j.neurobiolaging.2017.09.017. Epub 2017 Sep 28.

    PMID: 29050849RESULT

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
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

February 13, 2014

First Posted

April 10, 2014

Study Start

March 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations

DE(1)