The Effect of tES on a Cognitive Training

January 16, 2020 updated by: University of Bern

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3000
        • Klinik für Alterspsychiatrie und Psychotherapie UPD Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: sham tES healthy elderly
30 s of sham transcranial electric current stimulation applied via 5x7 cm and 10x10 cm rubber electrodes over the left DLPFC and supraorbital region. Additional ramp-up and ramp-down phase at beginning and end of stimulation lasting for 15 s. Electrodes remain attached to the participant's head for 20 minutes.
Device: sham 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.
PLACEBO_COMPARATOR: sham tES MCI
30 s of sham transcranial electric current stimulation applied via 5x7 cm and 10x10 cm rubber electrodes over the left DLPFC and supraorbital region. Additional ramp-up and ramp-down phase at beginning and end of stimulation lasting for 15 s. Electrodes remain attached to the participant's head for 20 minutes.
Device: sham tES MCI
A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the sham tES in the MCI group.
PLACEBO_COMPARATOR: sham tES AD
30 s of sham transcranial electric current stimulation applied via 5x7 cm and 10x10 cm rubber electrodes over the left DLPFC and supraorbital region. Additional ramp-up and ramp-down phase at beginning and end of stimulation lasting for 15 s. Electrodes remain attached to the participant's head for 20 minutes.
Device: sham tES AD
A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the sham tES in the AD group.
EXPERIMENTAL: real anodal tDCS healthy elderly
20 min of 2 mA real anodal transcranial direct current stimulation applied via 5x7 cm rubber electrode over the left DLPFC and cathodal 10x10 rubber electrode over supraorbital region. Additional ramp-up and ramp-down phase of 15 s at the beginning and the end of stimulation.
Device: real 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.
EXPERIMENTAL: real anodal tDCS MCI
20 min of 2 mA real anodal transcranial direct current stimulation applied via 5x7 cm rubber electrode over the left DLPFC and cathodal 10x10 rubber electrode over supraorbital region. Additional ramp-up and ramp-down phase of 15 s at the beginning and the end of stimulation.
Device: real anodal tDCS MCI
A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the real anodal tDCS in the MCI group.
EXPERIMENTAL: real anodal tDCS AD
20 min of 2 mA real anodal transcranial direct current stimulation applied via 5x7 cm rubber electrode over the left DLPFC and cathodal 10x10 rubber electrode over supraorbital region. Additional ramp-up and ramp-down phase of 15 s at the beginning and the end of stimulation.
Device: real anodal tDCS AD
A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the real anodal tDCS in the AD group.
EXPERIMENTAL: real tACS healthy elderly
20 min of 1 mA real transcranial alternating current stimulation in theta frequency applied via 5x7 cm rubber electrode over the left DLPFC and cathodal 10x10 rubber electrode over supraorbital region. Additional ramp-up and ramp-down phase of 15 s at the beginning and the end of stimulation.
Device: real 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.
EXPERIMENTAL: real tACS MCI
20 min of 1 mA real transcranial alternating current stimulation in theta frequency applied via 5x7 cm rubber electrode over the left DLPFC and cathodal 10x10 rubber electrode over supraorbital region. Additional ramp-up and ramp-down phase of 15 s at the beginning and the end of stimulation.
Device: real tACS MCI
A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the real tACS in the MCI group.
EXPERIMENTAL: real tACS AD
20 min of 1 mA real transcranial alternating current stimulation in theta frequency applied via 5x7 cm rubber electrode over the left DLPFC and cathodal 10x10 rubber electrode over supraorbital region. Additional ramp-up and ramp-down phase of 15 s at the beginning and the end of stimulation.
Device: real tACS AD
A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the real tACS in the AD group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-training (40-0 days before start of training)
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.
Post-training (0-40 days after end of training)
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.
Follow-up 1 (6 months after end of training)
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.
Follow-up 2 (12 months after end of training)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mood
Time Frame: Pre-training (40-0 days before start of training)
Changes in the subjective measure mood, assessed with questionnaire.
Pre-training (40-0 days before start of training)
Mood
Time Frame: Post-training (0-40 days after end of training)
Changes in the subjective measure mood, assessed with questionnaire.
Post-training (0-40 days after end of training)
Mood
Time Frame: Follow-up 1 (6 months after end of training)
Changes in the subjective measure mood, assessed with questionnaire.
Follow-up 1 (6 months after end of training)
Mood
Time Frame: Follow-up 2 (12 months after end of training)
Changes in the subjective measure mood, assessed with questionnaire.
Follow-up 2 (12 months after end of training)
QOL
Time Frame: Pre-training (40-0 days before start of training)
Changes in the subjective measure quality of life, assessed with questionnaire.
Pre-training (40-0 days before start of training)
QOL
Time Frame: Post-training (0-40 days after end of training)
Changes in the subjective measure quality of life, assessed with questionnaire.
Post-training (0-40 days after end of training)
QOL
Time Frame: Follow-up 1 (6 months after end of training)
Changes in the subjective measure quality of life, assessed with questionnaire.
Follow-up 1 (6 months after end of training)
QOL
Time Frame: Follow-up 2 (12 months after end of training)
Changes in the subjective measure quality of life, assessed with questionnaire.
Follow-up 2 (12 months after end of training)
AODL
Time Frame: Pre-training (40-0 days before start of training)
Changes in the subjective measure activities of daily living, assessed with questionnaire.
Pre-training (40-0 days before start of training)
AODL
Time Frame: Post-training (0-40 days after end of training)
Changes in the subjective measure activities of daily living, assessed with questionnaire.
Post-training (0-40 days after end of training)
AODL
Time Frame: Follow-up 1 (6 months after end of training)
Changes in the subjective measure activities of daily living, assessed with questionnaire.
Follow-up 1 (6 months after end of training)
AODL
Time Frame: Follow-up 2 (12 months after end of training)
Changes in the subjective measure activities of daily living, assessed with questionnaire.
Follow-up 2 (12 months after end of training)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
40-20 days before the start of the training with a questionnaire sent by mail.
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.
40-20 days before the start of the training with a questionnaire sent by mail.
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.
40-20 days before the start of the training with a questionnaire sent by mail.
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.
30-3 days before the start of the training with a questionnaire in the pre-assessment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bern

Investigators

  • Principal Investigator: Stefan Klöppel, Prof, University of Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 15, 2018

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

March 9, 2018

First Submitted That Met QC Criteria

March 22, 2018

First Posted (ACTUAL)

March 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 16, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-02056

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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