NCT03838211

Brief Summary

The aim of this study is to investigate whether a tDCS-accompanied intensive cognitive training of working memory leads to 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
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

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

October 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2020

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

1.2 years

First QC Date

February 1, 2019

Last Update Submit

April 30, 2021

Conditions

Aging

Keywords

memorybrain stimulation

Outcome Measures

Primary Outcomes (1)

  • Working memory training performance (Letter Updating task)

    Performance in a memory training task (Letter updating) under anodal tDCS compared to sham condition;operationalized by working Memory Updating performance assessed with number of correctly recalled letter lists in the letter updating task, analyzed immediately after training period (anodal condition versus sham)

    3 weeks

Secondary Outcomes (4)

  • Working memory training performance (Markov task)

    3 weeks

  • Transfer outcomes

    3 weeks

  • Long-term outcomes

    4 weeks after training, 6 months after 4-week follow-up

  • Neural correlates

    3 weeks, 6 months

Study Arms (2)

stimulation group

EXPERIMENTAL

Anodal tDCS + intensive cognitive Training

Device: Anodal tDCSBehavioral: Intensive cognitive training

sham group

SHAM COMPARATOR

Sham tDCS + intensive cognitive Training

Behavioral: Intensive cognitive training

Interventions

Anodal tDCSDEVICE

Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (current intensity of 1mA)

stimulation group
Intensive cognitive trainingBEHAVIORAL

Intensive cognitive training of a letter memory updating task and a 3-stage Markov decision making task, 9 sessions

sham groupstimulation group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Older adults (65 - 80 years);
  • Right handedness;
  • Unobtrusive neuropsychological screening

You may not qualify if:

  • Mild cognitive impairment (MCI) or dementia; other neurodegenerative neurological disorders; epilepsy; previous stroke;
  • Severe and untreated medical conditions that precludes participation in the training, as determined by responsible physician;
  • History of severe alcoholism or use of drugs;
  • Severe psychiatric disorders such as depression (if not in remission) or psychosis;
  • 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)

University Medicine Greifswald

Greifswald, 17475, Germany

Location

Related Publications (3)

  • Thams F, Li SC, Floel A, Antonenko D. Functional Connectivity and Microstructural Network Correlates of Interindividual Variability in Distinct Executive Functions of Healthy Older Adults. Neuroscience. 2023 Aug 21;526:61-73. doi: 10.1016/j.neuroscience.2023.06.005. Epub 2023 Jun 14.

    PMID: 37321368DERIVED

  • Antonenko D, Fromm AE, Thams F, Grittner U, Meinzer M, Floel A. Microstructural and functional plasticity following repeated brain stimulation during cognitive training in older adults. Nat Commun. 2023 Jun 2;14(1):3184. doi: 10.1038/s41467-023-38910-x.

    PMID: 37268628DERIVED

  • Antonenko D, Thams F, Uhrich J, Dix A, Thurm F, Li SC, Grittner U, Floel A. Effects of a Multi-Session Cognitive Training Combined With Brain Stimulation (TrainStim-Cog) on Age-Associated Cognitive Decline - Study Protocol for a Randomized Controlled Phase IIb (Monocenter) Trial. Front Aging Neurosci. 2019 Aug 16;11:200. doi: 10.3389/fnagi.2019.00200. eCollection 2019.

    PMID: 31474848DERIVED

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.

    University Medicine Greifswald

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2019

First Posted

February 12, 2019

Study Start

October 1, 2018

Primary Completion

December 1, 2019

Study Completion

March 25, 2020

Last Updated

May 3, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)