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The Effect of tES on a Cognitive Training

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ClinicalTrials.gov Identifier: NCT03475446
Recruitment Status : Completed
First Posted : March 23, 2018
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
University of Bern

Study Description
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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.

Condition or disease Intervention/treatment Phase
Memory Impairment Device: real anodal tDCS healthy elderly Device: real tACS healthy elderly Device: sham tES healthy elderly Device: real anodal tDCS MCI Device: real tACS MCI Device: sham tES MCI Device: real anodal tDCS AD Device: real tACS AD Device: sham tES AD Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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)
Masking: Double (Participant, Investigator)
Masking Description: Double blind design
Primary Purpose: Basic Science
Official Title: Modulating the Effect of a Computerized Cognitive Training With Transcranial Electrical Stimulation in Individuals With and Without Memory Impairment
Actual Study Start Date : January 15, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03475446


Locations
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Switzerland
Klinik für Alterspsychiatrie und Psychotherapie UPD Bern
Bern, Switzerland, 3000
Sponsors and Collaborators
University of Bern
Investigators
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Principal Investigator: Stefan Klöppel, Prof University of Bern
More Information
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Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT03475446    
Other Study ID Numbers: 2017-02056
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Bern:
Cognitive Training
Memory Impairment
Mild Cognitive Impairment
Alzheimer's Disease
 tES
tACS
tDCS
Additional relevant MeSH terms:
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Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases