Back to resultstES Effects on Associative Memory Performance
Primary Purpose
Healthy, Mild Cognitive Impairment, Alzheimer Disease
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
real anodal transcranial direct current stimulation
real transcranial alternating current stimulation
sham transcranial electric current stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Healthy
Eligibility Criteria
Inclusion Criteria:
- Written informed consent
- Non-smokers
- Right-handedness
- Native German speakers or comparable level of fluency
- Normal or corrected-to-normal vision
Exclusion Criteria:
- Neurological or psychiatric condition (other than diagnosed cognitive impairment)
- Past head injuries
- Magnetizable implants
- History of seizures
- Current or life-time alcohol or drug abuse
- Skin diseases
Sites / Locations
- University Hospital of Old Age Psychiatry and Psychotherapy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
Real tDCS
Real tACS
Sham tES
Arm Description
20 min of 2 mA real anodal transcranial direct current stimulation applied via 5x7 cm rubber electrode over the VLPFC (current density: 0.057 mA/cm2) and cathodal 10x10 rubber electrode over supraorbital region (current density: 0.02 mA/cm2). Additional ramp-up and ramp-down phase of 15 s at the beginning and the end of stimulation.
20 min of 2 mA real transcranial alternating current stimulation in theta frequency applied via 5x7 cm and 10x10 cm rubber electrodes over the VLPFC (current density: 0.057 mA/cm2) and supraorbital region (current density: 0.02 mA/cm2). Additional ramp-up and ramp-down phase of 15 s at the beginning and the end of stimulation.
30 s of 2 mA sham transcranial electric current stimulation applied via 5x7 cm and 10x10 cm rubber electrodes over the VLPFC (current density: 0.057 mA/cm2) and supraorbital region (current density: 0.02 mA/cm2). 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 the duration of the encoding phase of the memory task.
Outcomes
Primary Outcome Measures
Performance on immediate cued recall task
Number of correct responses on retrieval task of previously learned associative memory items
Performance on delayed cued recall task
Number of correct responses on retrieval task of previously learned associative memory items
Secondary Outcome Measures
task-dependent BOLD activity
Measured with functional magnetic resonance imaging (fMRI)
resting-state BOLD activity
Measured with functional magnetic resonance imaging (fMRI)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03351452
Brief Title
tES Effects on Associative Memory Performance
Official Title
Effects of Transcranial Electric Stimulation on Associative Memory Formation in Healthy Elderly Participants as Well as in Individuals With Memory Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 9, 2018 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
February 24, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Previous studies showed that transcranial electric stimulation (tES) applied over the prefrontal cortex improves cognitive performance in healthy elderly adults as well as in patients suffering from mild cognitive impairment or early Alzheimer's disease. Therefore, tES methods might be a useful intervention tool for patients suffering from memory impairment in early terms of the disease.
The present study aims at establishing a connection between the stimulation-induced changes on associative memory performance and its underlying neurophysiological parameters. tES effects and their underlying mechanisms will be compared between healthy elderly controls and clinical study populations receiving either real or sham tES over the left ventrolateral prefrontal cortex during an associative memory task.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Mild Cognitive Impairment, Alzheimer Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Real tDCS
Arm Type
Experimental
Arm Description
20 min of 2 mA real anodal transcranial direct current stimulation applied via 5x7 cm rubber electrode over the VLPFC (current density: 0.057 mA/cm2) and cathodal 10x10 rubber electrode over supraorbital region (current density: 0.02 mA/cm2). Additional ramp-up and ramp-down phase of 15 s at the beginning and the end of stimulation.
Arm Title
Real tACS
Arm Type
Experimental
Arm Description
20 min of 2 mA real transcranial alternating current stimulation in theta frequency applied via 5x7 cm and 10x10 cm rubber electrodes over the VLPFC (current density: 0.057 mA/cm2) and supraorbital region (current density: 0.02 mA/cm2). Additional ramp-up and ramp-down phase of 15 s at the beginning and the end of stimulation.
Arm Title
Sham tES
Arm Type
Sham Comparator
Arm Description
30 s of 2 mA sham transcranial electric current stimulation applied via 5x7 cm and 10x10 cm rubber electrodes over the VLPFC (current density: 0.057 mA/cm2) and supraorbital region (current density: 0.02 mA/cm2). 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 the duration of the encoding phase of the memory task.
Intervention Type
Device
Intervention Name(s)
real anodal transcranial direct current stimulation
Intervention Description
The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used.
Intervention Type
Device
Intervention Name(s)
real transcranial alternating current stimulation
Intervention Description
The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used.
Intervention Type
Device
Intervention Name(s)
sham transcranial electric current stimulation
Intervention Description
The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used.
Primary Outcome Measure Information:
Title
Performance on immediate cued recall task
Description
Number of correct responses on retrieval task of previously learned associative memory items
Time Frame
20 min
Title
Performance on delayed cued recall task
Description
Number of correct responses on retrieval task of previously learned associative memory items
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
task-dependent BOLD activity
Description
Measured with functional magnetic resonance imaging (fMRI)
Time Frame
20 min
Title
resting-state BOLD activity
Description
Measured with functional magnetic resonance imaging (fMRI)
Time Frame
10 min
Other Pre-specified Outcome Measures:
Title
Performance on cued recall task
Description
Number of correct responses on retrieval task of previously learned associative memory items
Time Frame
follow-up after 24 hours
Title
Performance on recognition task
Description
Number of correct responses on retrieval task of previously learned associative memory items
Time Frame
follow-up after 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Written informed consent
Non-smokers
Right-handedness
Native German speakers or comparable level of fluency
Normal or corrected-to-normal vision
Exclusion Criteria:
Neurological or psychiatric condition (other than diagnosed cognitive impairment)
Past head injuries
Magnetizable implants
History of seizures
Current or life-time alcohol or drug abuse
Skin diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Klöppel, Prof.Dr.med
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Old Age Psychiatry and Psychotherapy
City
Bern
ZIP/Postal Code
3000
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
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tES Effects on Associative Memory Performance
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