Clinical trial NCT03475446: The Effect of tES on a Cognitive Training
Official title: Modulating the Effect of a Computerized Cognitive Training With Transcranial Electrical Stimulation in Individuals With and Without Memory Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Memory Impairment
Keywords: Cognitive Training
Memory Impairment
Mild Cognitive Impairment
Alzheimer's Disease
tES
tACS
tDCS
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 65
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Memory
timeFrame: Pre-training (40-0 days before start of training)
measure: Memory
timeFrame: Post-training (0-40 days after end of training)
measure: Memory
timeFrame: Follow-up 1 (6 months after end of training)
measure: Memory
timeFrame: Follow-up 2 (12 months after end of training)
Secondary outcomes:
measure: Mood
timeFrame: Pre-training (40-0 days before start of training)
measure: Mood
timeFrame: Post-training (0-40 days after end of training)
measure: Mood
timeFrame: Follow-up 1 (6 months after end of training)
measure: Mood
timeFrame: Follow-up 2 (12 months after end of training)
measure: QOL
timeFrame: Pre-training (40-0 days before start of training)
measure: QOL
timeFrame: Post-training (0-40 days after end of training)
measure: QOL
timeFrame: Follow-up 1 (6 months after end of training)
measure: QOL
timeFrame: Follow-up 2 (12 months after end of training)
measure: AODL
timeFrame: Pre-training (40-0 days before start of training)
measure: AODL
timeFrame: Post-training (0-40 days after end of training)
measure: AODL
timeFrame: Follow-up 1 (6 months after end of training)
measure: AODL
timeFrame: Follow-up 2 (12 months after end of training)
Other outcomes:
measure: Years of Education
timeFrame: 40-20 days before the start of the training with a questionnaire sent by mail.
measure: Cognitive Reserve
timeFrame: 40-20 days before the start of the training with a questionnaire sent by mail.
measure: Personality
timeFrame: 40-20 days before the start of the training with a questionnaire sent by mail.
measure: Motivation
timeFrame: 30-3 days before the start of the training with a questionnaire in the pre-assessment.
Locations:
city: Bern
country: Switzerland
facility: Klinik für Alterspsychiatrie und Psychotherapie UPD Bern
Study officials:
affiliation: University of Bern
name: Stefan Klöppel, Prof
role: PRINCIPAL_INVESTIGATOR
References: