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

February 25, 2020 updated by: University of Bern

Supporting Episodic Memory With Transcranial Direct Current Stimulation in Healthy Young and Elderly Participants as Well as in Individuals With Memory Impairment

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3000
        • University Hospital of Old Age Psychiatry and Psychotherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Device: real anodal transcranial direct current stimulation (tDCS)
The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used in the study.
Device: sham transcranial direct current stimulation (tDCS)
The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used in the study.
EXPERIMENTAL: 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.
Device: real anodal transcranial direct current stimulation (tDCS)
The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used in the study.
Device: sham transcranial direct current stimulation (tDCS)
The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Episodic memory performance - learning curve
Time Frame: 0.25 hours
Number of encoded words during the three consecutive immediate retrievals in the encoding phase
0.25 hours
Episodic memory performance - delayed recall 1
Time Frame: 20 min after encoding phase
Number of remembered words in the delayed recall after a short delay at the day of the on-site visit
20 min after encoding phase
Episodic memory performance - delayed recall 2
Time Frame: 1 day after on-site visit
Number of remembered words one day after learning
1 day after on-site visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurotransmitter levels
Time Frame: 0.5 hours
Changes in neurotransmitter levels (gamma-Aminobutyric acid (GABA) and glutamatergic metabolites (Glx) due to tDCS (comparing pre- and post-stimulation measurements in DLPFC)
0.5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bern

Investigators

  • Principal Investigator: Stefan Klöppel, Prof, University Hospital of Old Age Psychiatry and Psychotherapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2017

Primary Completion (ACTUAL)

October 18, 2019

Study Completion (ACTUAL)

October 19, 2019

Study Registration Dates

First Submitted

July 19, 2017

First Submitted That Met QC Criteria

July 21, 2017

First Posted (ACTUAL)

July 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 25, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3351
  • 2016-02175 (OTHER: Cantonal Ethics Committee Bern)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on real anodal transcranial direct current stimulation (tDCS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe