NCT04705532

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Oct 2019

Longer than P75 for phase_1 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

Study Start

First participant enrolled

October 4, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

August 5, 2024

Status Verified

August 1, 2024

Enrollment Period

2.2 years

First QC Date

January 7, 2021

Last Update Submit

August 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 3-back

    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 Outcomes (3)

  • Stroop

    It will be measured over the course of four weeks

  • EEG - alpha power

    It will be measured over the course of four weeks

  • EEG - beta power

    It will be measured over the course of four weeks

Study Arms (4)

tDCS/music

EXPERIMENTAL

active tDCS combined with music

Device: tDCSOther: Music

sham tDCS/music

EXPERIMENTAL

Sham tDCS combined with music

Device: Sham tDCSOther: Music

tDCS/white noise

EXPERIMENTAL

active tDCS combined with white noise

Device: tDCSOther: White noise

sham tDCS/white noise

EXPERIMENTAL

sham tDCS combined with white noise

Device: Sham tDCSOther: White noise

Interventions

tDCSDEVICE

Multi-channel tDCS will be applied over the executive network for 20 minutes at 4mA

tDCS/musictDCS/white noise
Sham tDCSDEVICE

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.

sham tDCS/musicsham tDCS/white noise
MusicOTHER

Subjects will listen to their preferred music for 20 minutes

sham tDCS/musictDCS/music

Subjects will listen to a white noise for 20 minutes

sham tDCS/white noisetDCS/white noise

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy adults

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Liege

Liège, 4000, Belgium

Location

MeSH Terms

Interventions

Transcranial Direct Current StimulationMusic Therapy

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological TechniquesSensory Art TherapiesComplementary TherapiesRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapy

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 12, 2021

Study Start

October 4, 2019

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

August 5, 2024

Record last verified: 2024-08

Locations