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The Effect of tES on a Cognitive Training

Modulating the Effect of a Computerized Cognitive Training With Transcranial Electrical Stimulation in Individuals With and Without Memory Impairment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03475446
Enrollment
65
Registered
2018-03-23
Start date
2018-01-15
Completion date
2019-12-31
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Memory Impairment

Keywords

Cognitive Training, Memory Impairment, Mild Cognitive Impairment, Alzheimer's Disease, tES, tACS, tDCS

Brief summary

The aim of this study is to investigate the effect of a transcranial electrical stimulation (tES) on a cognitive training in healthy elderly and memory impaired participants. In order to assess these effects different memory and attention tasks will be performed before and after the training as well as after 6 and 12 months.

Detailed description

As other studies have shown, transcranial direct current stimulation (tDCS) can improve the outcome of memory tasks in Alzheimer's disease (AD), mild cognitive impairment (MCI) and healthy older adults. Only few studies have investigated the effect of the combination of tDCS and a simultaneous cognitive training and to the investigators' knowledge there is no comparison of tDCS and transcranial alternating current (tACS) effects during a cognitive training or for different populations. With results from this study existing trainings can be optimised. In total 180 participants are planned to be included in this study. This number is based on a g\*Power estimation. According to this estimation the study has to include 153 participants. Regarding similar studies the investigators assume a dropout rate of 15% resulting in a total of 180 participants (60 AD patients, 60 MCI patients and 60 healthy older adults) This number should make it possible to find the expected mild effects reported in literature. A mixed-effects ANOVA model with the between-subjects factor stimulation (tDCS, tACS, sham) and the within-subjects factor time will be computed.

Interventions

DEVICEreal anodal tDCS healthy elderly

A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the real anodal tDCS in the group of healthy elderly.

DEVICEreal tACS healthy elderly

A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the real tACS in the group of healthy elderly.

DEVICEsham tES healthy elderly

A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the sham tES in the group of healthy elderly.

DEVICEreal anodal tDCS MCI

A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the real anodal tDCS in the MCI group.

DEVICEreal tACS MCI

A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the real tACS in the MCI group.

DEVICEsham tES MCI

A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the sham tES in the MCI group.

DEVICEreal anodal tDCS AD

A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the real anodal tDCS in the AD group.

DEVICEreal tACS AD

A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the real tACS in the AD group.

DEVICEsham tES AD

A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the sham tES in the AD group.

Sponsors

University of Bern
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Masking description

Double blind design

Intervention model description

Participants are allocated to one of 3 groups: real tACS, real tDCS or sham. Each participant belongs also to a subpopulation with or without memory impairment (Healthy elderly, MCI, AD)

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* Able to give their consent to participate in the study * Native or fluent German speaker * Normal or corrected to normal vision and hearing * Ability to visit the study location for 14 appointments

Exclusion criteria

* Acute neurological (other than memory impairment) or psychiatric disorders * Seizures * Magnetisable implants * High dose of psychotropic drugs * Drug or alcohol abuse * Participation in another study with investigational drug * tES in the 2 months preceding or during the present study * Severe head injuries * Skin disease * Caffeine 3 hours prior to training

Design outcomes

Primary

MeasureTime frameDescription
MemoryPre-training (40-0 days before start of training)The primary outcome is the change in memory performance.Therefore, changes in the MMS/MoCA score (scores: 0-30, higher scores indicate better functioning of global memory and cognition) and a composite memory score will be assessed. The composite memory score is calculated with the scores of the episodic, prospective and working memory tests.

Secondary

MeasureTime frameDescription
MoodPre-training (40-0 days before start of training)Changes in the subjective measure mood, assessed with questionnaire.
QOLPre-training (40-0 days before start of training)Changes in the subjective measure quality of life, assessed with questionnaire.
AODLPre-training (40-0 days before start of training)Changes in the subjective measure activities of daily living, assessed with questionnaire.

Other

MeasureTime frameDescription
Years of Education40-20 days before the start of the training with a questionnaire sent by mail.Years of education is a possible predictor of the success of the training and will be assessed once.
Cognitive Reserve40-20 days before the start of the training with a questionnaire sent by mail.Cognitive reserve is a possible predictor of the success of the training and will be assessed once.
Personality40-20 days before the start of the training with a questionnaire sent by mail.Personality is a possible predictor of the success of the training and will be assessed once.
Motivation30-3 days before the start of the training with a questionnaire in the pre-assessment.Motivation is a possible predictor of the success of the training and will be assessed once.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026