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The Effect of tES on a Cognitive Training

Primary Purpose

Memory Impairment

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
real anodal tDCS healthy elderly
real tACS healthy elderly
sham tES healthy elderly
real anodal tDCS MCI
real tACS MCI
sham tES MCI
real anodal tDCS AD
real tACS AD
sham tES AD
Sponsored by
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Memory Impairment focused on measuring Cognitive Training, Memory Impairment, Mild Cognitive Impairment, Alzheimer's Disease, tES, tACS, tDCS

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Klinik für Alterspsychiatrie und Psychotherapie UPD Bern

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Placebo Comparator

Placebo Comparator

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

sham tES healthy elderly

sham tES MCI

sham tES AD

real anodal tDCS healthy elderly

real anodal tDCS MCI

real anodal tDCS AD

real tACS healthy elderly

real tACS MCI

real tACS AD

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Memory
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.
Memory
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.
Memory
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.
Memory
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 Outcome Measures

Mood
Changes in the subjective measure mood, assessed with questionnaire.
Mood
Changes in the subjective measure mood, assessed with questionnaire.
Mood
Changes in the subjective measure mood, assessed with questionnaire.
Mood
Changes in the subjective measure mood, assessed with questionnaire.
QOL
Changes in the subjective measure quality of life, assessed with questionnaire.
QOL
Changes in the subjective measure quality of life, assessed with questionnaire.
QOL
Changes in the subjective measure quality of life, assessed with questionnaire.
QOL
Changes in the subjective measure quality of life, assessed with questionnaire.
AODL
Changes in the subjective measure activities of daily living, assessed with questionnaire.
AODL
Changes in the subjective measure activities of daily living, assessed with questionnaire.
AODL
Changes in the subjective measure activities of daily living, assessed with questionnaire.
AODL
Changes in the subjective measure activities of daily living, assessed with questionnaire.

Full Information

First Posted
March 9, 2018
Last Updated
January 16, 2020
Sponsor
University of Bern
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1. Study Identification

Unique Protocol Identification Number
NCT03475446
Brief Title
The Effect of tES on a Cognitive Training
Official Title
Modulating the Effect of a Computerized Cognitive Training With Transcranial Electrical Stimulation in Individuals With and Without Memory Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Impairment
Keywords
Cognitive Training, Memory Impairment, Mild Cognitive Impairment, Alzheimer's Disease, tES, tACS, tDCS

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
ParticipantInvestigator
Masking Description
Double blind design
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sham tES healthy elderly
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
sham tES MCI
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
sham tES AD
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
real anodal tDCS healthy elderly
Arm Type
Experimental
Arm Description
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.
Arm Title
real anodal tDCS MCI
Arm Type
Experimental
Arm Description
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.
Arm Title
real anodal tDCS AD
Arm Type
Experimental
Arm Description
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.
Arm Title
real tACS healthy elderly
Arm Type
Experimental
Arm Description
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.
Arm Title
real tACS MCI
Arm Type
Experimental
Arm Description
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.
Arm Title
real tACS AD
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
real anodal tDCS healthy elderly
Intervention Description
A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the real anodal tDCS in the group of healthy elderly.
Intervention Type
Device
Intervention Name(s)
real tACS healthy elderly
Intervention Description
A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the real tACS in the group of healthy elderly.
Intervention Type
Device
Intervention Name(s)
sham tES healthy elderly
Intervention Description
A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the sham tES in the group of healthy elderly.
Intervention Type
Device
Intervention Name(s)
real anodal tDCS MCI
Intervention Description
A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the real anodal tDCS in the MCI group.
Intervention Type
Device
Intervention Name(s)
real tACS MCI
Intervention Description
A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the real tACS in the MCI group.
Intervention Type
Device
Intervention Name(s)
sham tES MCI
Intervention Description
A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the sham tES in the MCI group.
Intervention Type
Device
Intervention Name(s)
real anodal tDCS AD
Intervention Description
A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the real anodal tDCS in the AD group.
Intervention Type
Device
Intervention Name(s)
real tACS AD
Intervention Description
A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the real tACS in the AD group.
Intervention Type
Device
Intervention Name(s)
sham tES AD
Intervention Description
A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the sham tES in the AD group.
Primary Outcome Measure Information:
Title
Memory
Description
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.
Time Frame
Pre-training (40-0 days before start of training)
Title
Memory
Description
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.
Time Frame
Post-training (0-40 days after end of training)
Title
Memory
Description
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.
Time Frame
Follow-up 1 (6 months after end of training)
Title
Memory
Description
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.
Time Frame
Follow-up 2 (12 months after end of training)
Secondary Outcome Measure Information:
Title
Mood
Description
Changes in the subjective measure mood, assessed with questionnaire.
Time Frame
Pre-training (40-0 days before start of training)
Title
Mood
Description
Changes in the subjective measure mood, assessed with questionnaire.
Time Frame
Post-training (0-40 days after end of training)
Title
Mood
Description
Changes in the subjective measure mood, assessed with questionnaire.
Time Frame
Follow-up 1 (6 months after end of training)
Title
Mood
Description
Changes in the subjective measure mood, assessed with questionnaire.
Time Frame
Follow-up 2 (12 months after end of training)
Title
QOL
Description
Changes in the subjective measure quality of life, assessed with questionnaire.
Time Frame
Pre-training (40-0 days before start of training)
Title
QOL
Description
Changes in the subjective measure quality of life, assessed with questionnaire.
Time Frame
Post-training (0-40 days after end of training)
Title
QOL
Description
Changes in the subjective measure quality of life, assessed with questionnaire.
Time Frame
Follow-up 1 (6 months after end of training)
Title
QOL
Description
Changes in the subjective measure quality of life, assessed with questionnaire.
Time Frame
Follow-up 2 (12 months after end of training)
Title
AODL
Description
Changes in the subjective measure activities of daily living, assessed with questionnaire.
Time Frame
Pre-training (40-0 days before start of training)
Title
AODL
Description
Changes in the subjective measure activities of daily living, assessed with questionnaire.
Time Frame
Post-training (0-40 days after end of training)
Title
AODL
Description
Changes in the subjective measure activities of daily living, assessed with questionnaire.
Time Frame
Follow-up 1 (6 months after end of training)
Title
AODL
Description
Changes in the subjective measure activities of daily living, assessed with questionnaire.
Time Frame
Follow-up 2 (12 months after end of training)
Other Pre-specified Outcome Measures:
Title
Years of Education
Description
Years of education is a possible predictor of the success of the training and will be assessed once.
Time Frame
40-20 days before the start of the training with a questionnaire sent by mail.
Title
Cognitive Reserve
Description
Cognitive reserve is a possible predictor of the success of the training and will be assessed once.
Time Frame
40-20 days before the start of the training with a questionnaire sent by mail.
Title
Personality
Description
Personality is a possible predictor of the success of the training and will be assessed once.
Time Frame
40-20 days before the start of the training with a questionnaire sent by mail.
Title
Motivation
Description
Motivation is a possible predictor of the success of the training and will be assessed once.
Time Frame
30-3 days before the start of the training with a questionnaire in the pre-assessment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Klöppel, Prof
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Alterspsychiatrie und Psychotherapie UPD Bern
City
Bern
ZIP/Postal Code
3000
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of tES on a Cognitive Training

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