Behavioral and Neurophysiological Effects of Multichannel Executive Network tDCS Combined With Preferred Music Stimulation

October 20, 2021 updated by: Aurore Thibaut, University of Liege
This study aims at comparing the effects of transcranial direct current stimulation combined with music on neurophysiological outcomes in healthy participants. This study also aims to evaluate the effects of tDCS combined with music on cognition.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

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

Study Contact

Study Locations

  • Belgium
      • Liege, Belgium, 4000
        • Recruiting
        • University Hospital of Liege
        • Contact:
        • Contact:

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy adults

Exclusion Criteria:

  • neurological disorders
  • psychiatric disorders
  • contra-indication to tDCS (eg, metallic brain implant, pacemaker)
  • pregnancy
  • alcool abuse
  • active smoker

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tDCS/music
active tDCS combined with music
Device: tDCS
Multi-channel tDCS will be applied over the executive network for 20 minutes at 4mA
Other: Music
Subjects will listen to their preferred music for 20 minutes
Experimental: sham tDCS/music
Sham tDCS combined with music
Device: Sham tDCS
Sham tDCS will consist of applying the same parameters as for active but the corresponding device will be turned off after 30 seconds as to simulate the initial sensation of the active current. A current of 2mA will still be used (but turned off after 30 sec). The electrodes that will be used will be the same as for the active tDCS condition and the electrodes placement as well.
Other: Music
Subjects will listen to their preferred music for 20 minutes
Experimental: tDCS/white noise
active tDCS combined with white noise
Device: tDCS
Multi-channel tDCS will be applied over the executive network for 20 minutes at 4mA
Other: White noise
Subjects will listen to a white noise for 20 minutes
Experimental: sham tDCS/white noise
sham tDCS combined with white noise
Device: Sham tDCS
Sham tDCS will consist of applying the same parameters as for active but the corresponding device will be turned off after 30 seconds as to simulate the initial sensation of the active current. A current of 2mA will still be used (but turned off after 30 sec). The electrodes that will be used will be the same as for the active tDCS condition and the electrodes placement as well.
Other: White noise
Subjects will listen to a white noise for 20 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-back
Time Frame: It will be measured over the course of four weeks
The subject is presented with a sequence of stimuli, and the task consists of indicating when the current stimulus matches the one from 3 steps earlier in the sequence.
It will be measured over the course of four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroop
Time Frame: It will be measured over the course of four weeks
The subject has to name the font color of a printed word, while it can have a mismatch between the word and the color (ex: green is written in red).
It will be measured over the course of four weeks
EEG - alpha power
Time Frame: It will be measured over the course of four weeks
Brain activity will be measured with an electroencephalography collected at rest. We will first look at the change in alpha power (8-12Hz)
It will be measured over the course of four weeks
EEG - beta power
Time Frame: It will be measured over the course of four weeks
Brain activity will be measured with an electroencephalography collected at rest. We will also look at the change in other frequency bands (e.g., beta, theta, delta).
It will be measured over the course of four weeks

Collaborators and Investigators

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

Sponsor

University of Liege

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 4, 2019

Primary Completion (Anticipated)

December 30, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

January 7, 2021

First Submitted That Met QC Criteria

January 9, 2021

First Posted (Actual)

January 12, 2021

Study Record Updates

Last Update Posted (Actual)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 20, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2014-280

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.

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