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Memory ImpairmentNCT03475446

The Effect of tES on a Cognitive Training

A study testing real anodal tDCS healthy elderly, real tACS healthy elderly and real anodal tDCS MCI in people with Memory Impairment, run by University of Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Memory Impairment
What is being tested?
real anodal tDCS healthy elderly, real tACS healthy elderly and real anodal tDCS MCI
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
65 participants
Where
1 siteSwitzerland
Study dates
15 Jan 2018to 31 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • tES in the 2 months preceding or during the present study
  • Severe head injuries
  • Skin disease
  • Caffeine 3 hours prior to training

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Klinik für Alterspsychiatrie und Psychotherapie UPD Bern

    Bern, 3000

Other trials in Switzerland

About this study

Official title: 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.

Read the 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.

Being tested
real anodal tDCS healthy elderly, real tACS healthy elderly, sham tES healthy elderly, real anodal tDCS MCI, real tACS MCI
Keywords
Cognitive Training, Memory Impairment, Mild Cognitive Impairment, Alzheimer's Disease, tES, tACS, tDCS
Medical subject headings
Memory Disorders, Cognitive Dysfunction, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • real anodal tDCS healthy elderlyDevice

    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 elderlyDevice

    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 elderlyDevice

    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 MCIDevice

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

  • real tACS MCIDevice

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

  • sham tES MCIDevice

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

  • real anodal tDCS ADDevice

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

  • real tACS ADDevice

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

  • sham tES ADDevice

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

Study groups in NCT03475446
Study groupRoleWhat they receive
sham tES healthy elderlyPlacebo comparator30 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.
Receives: Device: sham tES healthy elderly
sham tES MCIPlacebo comparator30 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.
Receives: Device: sham tES MCI
sham tES ADPlacebo comparator30 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.
Receives: Device: sham tES AD
real anodal tDCS healthy elderlyExperimental20 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.
Receives: Device: real anodal tDCS healthy elderly
real anodal tDCS MCIExperimental20 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.
Receives: Device: real anodal tDCS MCI
real anodal tDCS ADExperimental20 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.
Receives: Device: real anodal tDCS AD
real tACS healthy elderlyExperimental20 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.
Receives: Device: real tACS healthy elderly
real tACS MCIExperimental20 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.
Receives: Device: real tACS MCI
real tACS ADExperimental20 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.
Receives: Device: real tACS AD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

Secondary outcomes (12)

  1. Mood

    Changes in the subjective measure mood, assessed with questionnaire.

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

  2. Mood

    Changes in the subjective measure mood, assessed with questionnaire.

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

  3. Mood

    Changes in the subjective measure mood, assessed with questionnaire.

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

  4. Mood

    Changes in the subjective measure mood, assessed with questionnaire.

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

  5. QOL

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

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

  6. QOL

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

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

  7. QOL

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

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

  8. QOL

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

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

  9. AODL

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

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

  10. AODL

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

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

  11. AODL

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

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

  12. AODL

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2018
  2. Study start15 Jan 2018
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Investigator
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03475446
Sponsor's protocol ID
2017-02056
Other IDs
2017
Status last verified
Jan 2020
First submitted
9 Mar 2018
Last updated
18 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Krebs C, Peter J, Brill E, Kloppel S, Brem AK. The moderating effects of sex, age, and education on the outcome of combined cognitive training and transcranial electrical stimulation in older adults. Front Psychol. 2023 Sep 22;14:1243099. doi: 10.3389/fpsyg.2023.1243099. eCollection 2023.

    PubMed 37809311

Questions about this trial

What is this clinical trial studying?

A study testing real anodal tDCS healthy elderly, real tACS healthy elderly and real anodal tDCS MCI in people with Memory Impairment, run by University of Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Memory (time frame: Pre-training (40-0 days before start of training)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03475446, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.

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