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

NCT ID: NCT03227185

Last Updated: 2020-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-10-19

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Mild Cognitive Impairment Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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..
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Real - sham anodal tDCS

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.

Group Type EXPERIMENTAL

real anodal transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used in the study.

sham transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used in the study.

Sham - real anodal tDCS

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.

Group Type EXPERIMENTAL

real anodal transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used in the study.

sham transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used in the study.

Interventions

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real anodal transcranial direct current stimulation (tDCS)

The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used in the study.

Intervention Type DEVICE

sham transcranial direct current stimulation (tDCS)

The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used in the study.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Klöppel, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Old Age Psychiatry and Psychotherapy

Locations

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University Hospital of Old Age Psychiatry and Psychotherapy

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2016-02175

Identifier Type: OTHER

Identifier Source: secondary_id

3351

Identifier Type: -

Identifier Source: org_study_id

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