NCT02110043

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 in learning and memory in patients with mild cognitive impairment (MCI) 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
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 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
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

May 21, 2021

Status Verified

May 1, 2021

Enrollment Period

3.4 years

First QC Date

February 13, 2014

Last Update Submit

May 20, 2021

Conditions

Mild Cognitive Impairment (MCI)

Keywords

mild cognitive impairment (MCI)tDCSLOCATO 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 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 (7)

  • long term effects

    after 1 month vs baseline

  • functional changes: Connectivity

    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

  • +2 more secondary outcomes

Study Arms (2)

training + tDCS

EXPERIMENTAL

Combination of intensive training of visual-spatial abilities (LOCATO task) with anodal 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 VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • right handedness
  • amnestic and amnestic plus MCI with:
  • subjective memory impairment;
  • objective memory difficulties, at least 1 SD below gender, age and education adjusted standard values;
  • relatively normal performance in other cognitive domains;
  • no constraints in activities of daily livings
  • 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 (1)

  • Kulzow N, Kerti L, Witte VA, Kopp U, Breitenstein C, Floel A. An object location memory paradigm for older adults with and without mild cognitive impairment. J Neurosci Methods. 2014 Nov 30;237:16-25. doi: 10.1016/j.jneumeth.2014.08.020. Epub 2014 Aug 28.

    PMID: 25176026BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

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

August 1, 2017

Study Completion

October 1, 2017

Last Updated

May 21, 2021

Record last verified: 2021-05

Locations

DE(1)