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Completed

NCT Number: NCT03475446

The Effect of tES on a Cognitive Training

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.

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Key information

Conditions

Memory Impairment Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Memory Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Tauopathies

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Alterspsychiatrie und Psychotherapie UPD Bern

Bern, 3000, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

real anodal tDCS healthy elderly

Device

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

real tACS healthy elderly

Device

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

sham tES healthy elderly

Device

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

real anodal tDCS MCI

Device

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

real tACS MCI

Device

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

sham tES MCI

Device

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

real anodal tDCS AD

Device

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

real tACS AD

Device

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

sham tES AD

Device

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

Primary outcomes

  1. Memory

    Time frame: Pre-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.

  2. Memory

    Time frame: Post-training (0-40 days after end 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.

  3. Memory

    Time frame: Follow-up 1 (6 months after end 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.

  4. Memory

    Time frame: Follow-up 2 (12 months after end 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 outcomes

  1. Mood

    Time frame: Pre-training (40-0 days before start of training)

    Changes in the subjective measure mood, assessed with questionnaire.

  2. Mood

    Time frame: Post-training (0-40 days after end of training)

    Changes in the subjective measure mood, assessed with questionnaire.

  3. Mood

    Time frame: Follow-up 1 (6 months after end of training)

    Changes in the subjective measure mood, assessed with questionnaire.

  4. Mood

    Time frame: Follow-up 2 (12 months after end of training)

    Changes in the subjective measure mood, assessed with questionnaire.

  5. QOL

    Time frame: Pre-training (40-0 days before start of training)

    Changes in the subjective measure quality of life, assessed with questionnaire.

  6. QOL

    Time frame: Post-training (0-40 days after end of training)

    Changes in the subjective measure quality of life, assessed with questionnaire.

  7. QOL

    Time frame: Follow-up 1 (6 months after end of training)

    Changes in the subjective measure quality of life, assessed with questionnaire.

  8. QOL

    Time frame: Follow-up 2 (12 months after end of training)

    Changes in the subjective measure quality of life, assessed with questionnaire.

  9. AODL

    Time frame: Pre-training (40-0 days before start of training)

    Changes in the subjective measure activities of daily living, assessed with questionnaire.

  10. AODL

    Time frame: Post-training (0-40 days after end of training)

    Changes in the subjective measure activities of daily living, assessed with questionnaire.

  11. AODL

    Time frame: Follow-up 1 (6 months after end of training)

    Changes in the subjective measure activities of daily living, assessed with questionnaire.

  12. AODL

    Time frame: Follow-up 2 (12 months after end of training)

    Changes in the subjective measure activities of daily living, assessed with questionnaire.

Other outcomes

  1. Years of Education

    Time frame: 40-20 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.

  2. Cognitive Reserve

    Time frame: 40-20 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.

  3. Personality

    Time frame: 40-20 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.

  4. Motivation

    Time frame: 30-3 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.

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 23, 2018
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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