NCT03475446

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 23, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

March 9, 2018

Last Update Submit

January 16, 2020

Conditions

Memory Impairment

Keywords

Cognitive TrainingMemory ImpairmentMild Cognitive ImpairmentAlzheimer's DiseasetEStACStDCS

Outcome Measures

Primary Outcomes (4)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (12)

  • Mood

    Pre-training (40-0 days before start of training)

  • Mood

    Post-training (0-40 days after end of training)

  • Mood

    Follow-up 1 (6 months after end of training)

  • Mood

    Follow-up 2 (12 months after end of training)

  • QOL

    Pre-training (40-0 days before start of training)

  • +7 more secondary outcomes

Other Outcomes (4)

  • Years of Education

    40-20 days before the start of the training with a questionnaire sent by mail.

  • Cognitive Reserve

    40-20 days before the start of the training with a questionnaire sent by mail.

  • Personality

    40-20 days before the start of the training with a questionnaire sent by mail.

  • +1 more other outcomes

Study Arms (9)

sham tES healthy elderly

PLACEBO COMPARATOR

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.

Device: sham tES healthy elderly

sham tES MCI

PLACEBO COMPARATOR

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.

Device: sham tES MCI

sham tES AD

PLACEBO COMPARATOR

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.

Device: sham tES AD

real anodal tDCS healthy elderly

EXPERIMENTAL

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.

Device: real anodal tDCS healthy elderly

real anodal tDCS MCI

EXPERIMENTAL

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.

Device: real anodal tDCS MCI

real anodal tDCS AD

EXPERIMENTAL

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.

Device: real anodal tDCS AD

real tACS healthy elderly

EXPERIMENTAL

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.

Device: real tACS healthy elderly

real tACS MCI

EXPERIMENTAL

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.

Device: real tACS MCI

real tACS AD

EXPERIMENTAL

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.

Device: real tACS AD

Interventions

real anodal tDCS healthy elderlyDEVICE

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 healthy elderly
real tACS healthy elderlyDEVICE

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

real tACS healthy elderly
sham tES healthy elderlyDEVICE

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

sham tES healthy elderly
real anodal tDCS MCIDEVICE

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

real anodal tDCS MCI
real tACS MCIDEVICE

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

real tACS MCI
sham tES MCIDEVICE

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

sham tES MCI
real anodal tDCS ADDEVICE

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

real anodal tDCS AD
real tACS ADDEVICE

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

real tACS AD
sham tES ADDEVICE

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

sham tES AD

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Alterspsychiatrie und Psychotherapie UPD Bern

Bern, 3000, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 37809311DERIVED

MeSH Terms

Conditions

Memory DisordersCognitive DysfunctionAlzheimer Disease

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesTauopathiesNeurodegenerative Diseases

Study Officials

  • Stefan Klöppel, Prof

    University of Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blind design
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2018

First Posted

March 23, 2018

Study Start

January 15, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)