The Effect of tES on a Cognitive Training

Memory Impairment Clinical Trial

Official title:

Modulating the Effect of a Computerized Cognitive Training With Transcranial Electrical Stimulation in Individuals With and Without Memory Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03475446
• Other study ID #: 2017-02056
• Status: Completed
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 months.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Memory Disorders
• Memory Impairment

Intervention

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

Locations

Country	Name	City	State
Switzerland	Klinik für Alterspsychiatrie und Psychotherapie UPD Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Years of Education	Years of education is a possible predictor of the success of the training and will be assessed once.	40-20 days before the start of the training with a questionnaire sent by mail.
Other	Cognitive Reserve	Cognitive reserve is a possible predictor of the success of the training and will be assessed once.	40-20 days before the start of the training with a questionnaire sent by mail.
Other	Personality	Personality is a possible predictor of the success of the training and will be assessed once.	40-20 days before the start of the training with a questionnaire sent by mail.
Other	Motivation	Motivation is a possible predictor of the success of the training and will be assessed once.	30-3 days before the start of the training with a questionnaire in the pre-assessment.
Primary	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.	Pre-training (40-0 days before start of training)
Primary	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.	Post-training (0-40 days after end of training)
Primary	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.	Follow-up 1 (6 months after end of training)
Primary	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.	Follow-up 2 (12 months after end of training)
Secondary	Mood	Changes in the subjective measure mood, assessed with questionnaire.	Pre-training (40-0 days before start of training)
Secondary	Mood	Changes in the subjective measure mood, assessed with questionnaire.	Post-training (0-40 days after end of training)
Secondary	Mood	Changes in the subjective measure mood, assessed with questionnaire.	Follow-up 1 (6 months after end of training)
Secondary	Mood	Changes in the subjective measure mood, assessed with questionnaire.	Follow-up 2 (12 months after end of training)
Secondary	QOL	Changes in the subjective measure quality of life, assessed with questionnaire.	Pre-training (40-0 days before start of training)
Secondary	QOL	Changes in the subjective measure quality of life, assessed with questionnaire.	Post-training (0-40 days after end of training)
Secondary	QOL	Changes in the subjective measure quality of life, assessed with questionnaire.	Follow-up 1 (6 months after end of training)
Secondary	QOL	Changes in the subjective measure quality of life, assessed with questionnaire.	Follow-up 2 (12 months after end of training)
Secondary	AODL	Changes in the subjective measure activities of daily living, assessed with questionnaire.	Pre-training (40-0 days before start of training)
Secondary	AODL	Changes in the subjective measure activities of daily living, assessed with questionnaire.	Post-training (0-40 days after end of training)
Secondary	AODL	Changes in the subjective measure activities of daily living, assessed with questionnaire.	Follow-up 1 (6 months after end of training)
Secondary	AODL	Changes in the subjective measure activities of daily living, assessed with questionnaire.	Follow-up 2 (12 months after end of training)