The Effect of tES on a Cognitive Training

NCT ID: NCT03475446

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Memory Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
Double blind design

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type PLACEBO_COMPARATOR

sham tES healthy elderly

Intervention Type DEVICE

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

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.

Group Type PLACEBO_COMPARATOR

sham tES MCI

Intervention Type DEVICE

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

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.

Group Type PLACEBO_COMPARATOR

sham tES AD

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

real anodal tDCS healthy elderly

Intervention Type 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 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.

Group Type EXPERIMENTAL

real anodal tDCS MCI

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

real anodal tDCS AD

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

real tACS healthy elderly

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

real tACS MCI

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

real tACS AD

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

real tACS MCI

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

Intervention Type DEVICE

sham tES MCI

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

Intervention Type 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.

Intervention Type DEVICE

real tACS AD

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

Intervention Type DEVICE

sham tES AD

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Bern

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stefan Klöppel, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Klinik für Alterspsychiatrie und Psychotherapie UPD Bern

Bern, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37809311 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-02056

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Stimulation to Improve Memory
NCT03875326 COMPLETED NA
Combined tDCS and Cognitive Training in Alzheimer's
NCT06861231 ENROLLING_BY_INVITATION NA