The Effect of tES on a Cognitive Training

University of Bern

Status: Completed

Conditions: Memory Impairment

Treatments: Device: real anodal tDCS AD; Device: sham tES MCI; Device: sham tES AD; Device: real tACS AD; Device: real anodal tDCS MCI; Device: real tACS healthy elderly; Device: sham tES healthy elderly; Device: real tACS MCI; Device: real anodal tDCS healthy elderly

Study type: Interventional

Funder types: Other

Identifiers

NCT03475446

2017-02056

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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65 participants in 9 patient groups, including a placebo group

sham tES healthy elderly

Placebo Comparator group

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.

Treatment:

Device: sham tES healthy elderly

sham tES MCI

Placebo Comparator group

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.

Treatment:

Device: sham tES MCI

sham tES AD

Placebo Comparator group

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.

Treatment:

Device: sham tES AD

real anodal tDCS healthy elderly

Experimental group

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.

Treatment:

Device: real anodal tDCS healthy elderly

real anodal tDCS MCI

Experimental group

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.

Treatment:

Device: real anodal tDCS MCI

real anodal tDCS AD

Experimental group

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.

Treatment:

Device: real anodal tDCS AD

real tACS healthy elderly

Experimental group

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.

Treatment:

Device: real tACS healthy elderly

real tACS MCI

Experimental group

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.

Treatment:

Device: real tACS MCI

real tACS AD

Experimental group

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.

Treatment:

Device: real tACS AD