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Supporting Episodic Memory With Transcranial Direct Current Stimulation in Healthy Controls and Dementia Patients

Primary Purpose

Healthy, Mild Cognitive Impairment, Alzheimer Disease

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
real anodal transcranial direct current stimulation (tDCS)
sham transcranial direct current stimulation (tDCS)
Sponsored by
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Written informed consent
  • Right-handedness
  • Non-smokers
  • 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
  • Pregnancy
  • Skin diseases

Sites / Locations

  • University Hospital of Old Age Psychiatry and Psychotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Real - sham anodal tDCS

Sham - real anodal tDCS

Arm Description

Session 1: 20 min of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 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. Session 2: 30 s of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 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.

Session 1: 30 s of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 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. Session 2: 20 min of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 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.

Outcomes

Primary Outcome Measures

Episodic memory performance - learning curve
Number of encoded words during the three consecutive immediate retrievals in the encoding phase
Episodic memory performance - delayed recall 1
Number of remembered words in the delayed recall after a short delay at the day of the on-site visit
Episodic memory performance - delayed recall 2
Number of remembered words one day after learning

Secondary Outcome Measures

Neurotransmitter levels
Changes in neurotransmitter levels (gamma-Aminobutyric acid (GABA) and glutamatergic metabolites (Glx) due to tDCS (comparing pre- and post-stimulation measurements in DLPFC)

Full Information

First Posted
July 19, 2017
Last Updated
February 25, 2020
Sponsor
University of Bern
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1. Study Identification

Unique Protocol Identification Number
NCT03227185
Brief Title
Supporting Episodic Memory With Transcranial Direct Current Stimulation in Healthy Controls and Dementia Patients
Official Title
Supporting Episodic Memory With Transcranial Direct Current Stimulation in Healthy Young and Elderly Participants as Well as in Individuals With Memory Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
No patients populations included ==> could not be recruited in meaningful numbers to allow conclusions.
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
October 18, 2019 (Actual)
Study Completion Date
October 19, 2019 (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 anodal tDCS applied over the dorsolateral prefrontal cortex (DLPFC) improved episodic memory performance, indicating a possible use as an intervention for patients suffering from memory impairments. At the same time, only scant evidence (provided by functional magnetic resonance imaging (fMRI) and magnetic resonance spectroscopy (MRS)) exists regarding the underlying mechanisms, thus hindering a more targeted application. The present study aims at establishing a connection between the stimulation-induced change in episodic memory performance on the behavioural level and neurophysiological parameters. TDCS effects and the underlying mechanisms will be compared between different study conditions, receiving either real anodal tDCS or sham stimulation over the left dorsolateral prefrontal cortex during an episodic 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
Model Description
Participants will be randomly assigned to two possible sequences of stimulation conditions. Group 1 will receive real tDCS stimulation to the left dlPFC during encoding on the first day and sham stimulation on the second day, and group 2 will receive sham stimulation during encoding on the first day and real tDCS on the second day. The participants will be randomized with equal probability to each of the two groups, using block randomization..
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real - sham anodal tDCS
Arm Type
Experimental
Arm Description
Session 1: 20 min of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 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. Session 2: 30 s of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 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.
Arm Title
Sham - real anodal tDCS
Arm Type
Experimental
Arm Description
Session 1: 30 s of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 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. Session 2: 20 min of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 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.
Intervention Type
Device
Intervention Name(s)
real anodal transcranial direct current stimulation (tDCS)
Intervention Description
The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used in the study.
Intervention Type
Device
Intervention Name(s)
sham transcranial direct current stimulation (tDCS)
Intervention Description
The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used in the study.
Primary Outcome Measure Information:
Title
Episodic memory performance - learning curve
Description
Number of encoded words during the three consecutive immediate retrievals in the encoding phase
Time Frame
0.25 hours
Title
Episodic memory performance - delayed recall 1
Description
Number of remembered words in the delayed recall after a short delay at the day of the on-site visit
Time Frame
20 min after encoding phase
Title
Episodic memory performance - delayed recall 2
Description
Number of remembered words one day after learning
Time Frame
1 day after on-site visit
Secondary Outcome Measure Information:
Title
Neurotransmitter levels
Description
Changes in neurotransmitter levels (gamma-Aminobutyric acid (GABA) and glutamatergic metabolites (Glx) due to tDCS (comparing pre- and post-stimulation measurements in DLPFC)
Time Frame
0.5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Written informed consent Right-handedness Non-smokers 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 Pregnancy Skin diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Klöppel, Prof
Organizational Affiliation
University Hospital of Old Age Psychiatry and Psychotherapy
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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Supporting Episodic Memory With Transcranial Direct Current Stimulation in Healthy Controls and Dementia Patients

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