HealthyPhase 1NCT04705532
Behavioral and Neurophysiological Effects of Multichannel Executive Network tDCS Combined With Preferred Music Stimulation
A Phase 1 study testing tDCS, Music and White noise in people with Healthy, run by University of Liege at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- tDCS, Music and White noise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Oct 2019to 30 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy adults
Who cannot join
- neurological disorders
- psychiatric disorders
- contra-indication to tDCS (eg, metallic brain implant, pacemaker)
- pregnancy
- alcool abuse
- active smoker
Trial locations and contacts
1 site in 1 country.
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Multi-channel tDCS will be applied over the executive network for 20 minutes at 4mA
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.
MusicOther
Subjects will listen to their preferred music for 20 minutes
White noiseOther
Subjects will listen to a white noise for 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| tDCS/music | Experimental | active tDCS combined with music Receives: Device: tDCS; Other: Music |
| sham tDCS/music | Experimental | Sham tDCS combined with music Receives: Device: Sham tDCS; Other: Music |
| tDCS/white noise | Experimental | active tDCS combined with white noise Receives: Device: tDCS; Other: White noise |
| sham tDCS/white noise | Experimental | sham tDCS combined with white noise Receives: Device: Sham tDCS; Other: White noise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: It will be measured over the course of four weeks
Secondary outcomes (3)
Stroop
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).
Measured: It will be measured over the course of four weeks
EEG - alpha power
Brain activity will be measured with an electroencephalography collected at rest. We will first look at the change in alpha power (8-12Hz)
Measured: It will be measured over the course of four weeks
EEG - beta power
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).
Measured: It will be measured over the course of four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start4 Oct 2019
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aurore Thibaut, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705532
- Sponsor's protocol ID
- 2014-280
- Status last verified
- Aug 2024
- First submitted
- 7 Jan 2021
- Last updated
- 5 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral and Neurophysiological Effects of Multichannel Executive Network tDCS Combined With Preferred Music Stimulation
- ClinicalTrials.gov ID
- NCT04705532
- Acronym / sponsor ID
- 2014-280
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| tDCS/music | Experimental | Device: tDCS, Other: Musicactive tDCS combined with music |
| sham tDCS/music | Experimental | Device: Sham tDCS, Other: MusicSham tDCS combined with music |
| tDCS/white noise | Experimental | Device: tDCS, Other: White noiseactive tDCS combined with white noise |
| sham tDCS/white noise | Experimental | Device: Sham tDCS, Other: White noisesham tDCS combined with white noise |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy adults
Key exclusion criteria (6 listed)
- neurological disorders
- psychiatric disorders
- contra-indication to tDCS (eg, metallic brain implant, pacemaker)
- pregnancy
- alcool abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSMulti-channel tDCS will be applied over the executive network for 20 minutes at 4mA | Device | tDCS/music, tDCS/white noise |
| Sham tDCSSham 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. | Device | sham tDCS/music, sham tDCS/white noise |
| MusicSubjects will listen to their preferred music for 20 minutes | Other | sham tDCS/music, tDCS/music |
| White noiseSubjects will listen to a white noise for 20 minutes | Other | sham tDCS/white noise, tDCS/white noise |
Primary outcome
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.
3 secondary outcomes
Stroop
Time frame: 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
EEG - beta power
Time frame: It will be measured over the course of four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tDCS, Music and White noise in people with Healthy, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-back (time frame: It will be measured over the course of four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.