The Effect of tES on a Cognitive Training

Not Applicable

Completed

• Conditions: Memory Impairment
• Interventions: Device: real tACS healthy elderly; Device: sham tES healthy elderly; Device: sham tES AD; Device: sham tES MCI; Device: real tACS AD; Device: real anodal tDCS healthy elderly; Device: real anodal tDCS MCI; Device: real anodal tDCS AD; Device: real tACS MCI

• Registration Number: NCT03475446
• Lead Sponsor: University of Bern

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.

Study Timeline

• Study Start: 2018-01-15
• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-03-22
• Study First Posted: 2018-03-23
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-16
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
real tACS healthy elderly	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.
sham tES healthy elderly	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.
sham tES AD	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.
sham tES MCI	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.
real tACS AD	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.
real anodal tDCS healthy elderly	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.
real anodal tDCS MCI	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.
real anodal tDCS AD	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.
real tACS MCI	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.

Primary Outcome Measures

Name	Time	Method
Memory	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

Name	Time	Method
Mood	Follow-up 2 (12 months after end of training)	Changes in the subjective measure mood, assessed with questionnaire.
QOL	Follow-up 2 (12 months after end of training)	Changes in the subjective measure quality of life, assessed with questionnaire.
AODL	Follow-up 2 (12 months after end of training)	Changes in the subjective measure activities of daily living, assessed with questionnaire.

Trial Locations

Locations (1)

Klinik für Alterspsychiatrie und Psychotherapie UPD Bern; 🇨🇭 Bern, Switzerland