NCT03351452

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable healthy

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

First Submitted

Initial submission to the registry

November 14, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

April 9, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2020

Completed
Last Updated

March 13, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

November 14, 2017

Last Update Submit

March 12, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Performance on immediate cued recall task

    Number of correct responses on retrieval task of previously learned associative memory items

    20 min

  • Performance on delayed cued recall task

    Number of correct responses on retrieval task of previously learned associative memory items

    24 hours

Secondary Outcomes (2)

  • task-dependent BOLD activity

    20 min

  • resting-state BOLD activity

    10 min

Other Outcomes (2)

  • Performance on cued recall task

    follow-up after 24 hours

  • Performance on recognition task

    follow-up after 24 hours

Study Arms (3)

Real tDCS

EXPERIMENTAL

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.

Device: real anodal transcranial direct current stimulation

Real tACS

EXPERIMENTAL

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.

Device: real transcranial alternating current stimulation

Sham tES

SHAM COMPARATOR

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.

Device: sham transcranial electric current stimulation

Interventions

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

Real tDCS

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

Real tACS

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

Sham tES

Eligibility Criteria

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

You may qualify if:

  • Written informed consent
  • Non-smokers
  • Right-handedness
  • Native German speakers or comparable level of fluency
  • Normal or corrected-to-normal vision

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Old Age Psychiatry and Psychotherapy

Bern, 3000, Switzerland

Location

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer Disease

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative Diseases

Study Officials

  • Stefan Klöppel, Prof.Dr.med

    University of Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2017

First Posted

November 22, 2017

Study Start

April 9, 2018

Primary Completion

September 30, 2018

Study Completion

February 24, 2020

Last Updated

March 13, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations