NCT02110407

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 young 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
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

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

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
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

2.8 years

First QC Date

February 13, 2014

Last Update Submit

July 26, 2017

Conditions

Keywords

healthy young 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 improvement of visual-spatial learning and memory measured by the performance in LOCATO task after end of a 3 day period of training compared to sham stimulation.

    immediately after end of a 3 day period of training in tDCS condition vs sham condition

Secondary Outcomes (6)

  • long term effects

    after 1 month vs baseline

  • functional changes: Connectivity

    after end of 3-day cognitive 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

  • +1 more secondary outcomes

Study Arms (2)

training + sham stimulation

SHAM COMPARATOR

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

Device: tDCSBehavioral: training

training + tDCS

EXPERIMENTAL

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

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

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • right handednesss
  • unobtrusive neuropsychological screening
  • age: 18-35 years

You may not qualify if:

  • severe internal or psychiatric disease
  • epilepsy
  • other severe neurological disease, e.g. previous major stroke, 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

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

January 1, 2017

Study Completion

May 1, 2017

Last Updated

July 27, 2017

Record last verified: 2017-07

Locations