tDCS MechanismsNCT04577677
Understanding the Neural Mechanisms Behind tDCS
A study testing brain stimulation in people with tDCS Mechanisms, run by KU Leuven at 1 site in Belgium.
Trial summary
The aim of the study is to investigate the neural mechanisms underpinning transcranial direct current stimulation (tDCS), a non-invasive neuromodulation technique in which a direct current is passed through scalp electrodes. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- tDCS Mechanisms
- What is being tested?
- brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2020to 31 Dec 2024
- Phase
- Interventional
- 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
- good general health
Who cannot join
- Epilepsy or family history of epilepsy
- Migraine
- Allergic to lidocaine or benzocaine
- Pregnant
- History of or currently suffering from:
- neurological diseases
Show all 19Show fewer
- psychiatric diseases, depression or anxiety (Annex B and Annex C)
- History of:
- brain surgery
- brain thrombosis
- cerebral hemorrhage
- severe head trauma
- meningitis
- long period of loss of consciousness (> 1 hour)
- Metal parts in the head or upper body:
- Defibrillator, implanted medication pump
- Metal prosthesis in ear, hart, …
- Deep brain stimulator
- Coronary bypass or intracranial or aneurysm clips (brain arteries, aorta, etc.)
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
KULeuven
Leuven, Vlaams-Brabant, 3000
Myles Mc Laughlin, professor, +32 16 32 43 48, myles.mclaughlin@kuleuven.be
About this study
Official title: Understanding the Neural Mechanisms Behind Transcranial Direct Current Stimulation
The aim of the study is to investigate the neural mechanisms underpinning transcranial direct current stimulation (tDCS), a non-invasive neuromodulation technique in which a direct current is passed through scalp electrodes. A series of experiments will be conducted to understand and characterize the transcranial and transcutaneous mechanisms of tDCS. To investigate this research question, every participant will undergo three stimulation conditions (active, sham and control). In the control condition, an anaesthetic cream will be applied to anaesthetize the nerves in the scalp. In addition, the effectiveness of tDCS and peripheral nerve stimulation will be compared. Ultimately, the obtained knowledge can lead to the development of improved non-invasive neuromodulation therapies, which can lead to more effective treatments of a variety of neurological and psychiatric disorders.
- Conditions
- tDCS Mechanisms
- Being tested
- brain stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brain stimulationDevice
Also called skin intervention
tDCS and peripheral nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| optimization of control anesthetic condition | Experimental | Not described Receives: Device: brain stimulation |
| understanding tDCS effect on motor learning | Experimental | Not described Receives: Device: brain stimulation |
| understanding tDCS effects on cortical excitability | Experimental | Not described Receives: Device: brain stimulation |
| optimizing peripheral nerve stimulation protocols | Experimental | Not described Receives: Device: brain stimulation |
| Effect peripheral nerve stimulation on motor learning | Experimental | Not described Receives: Device: brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Rate sensation from 0 ('I feel nothing') to 10 ('Stimulation is painful')
Measured: 30 minutes during stimulation
Reaction time
Reaction time on the motor learning task
Measured: 20 minutes during tDCS stimulation
Reaction time
Reaction time on motor learning task
Measured: 20 minutes during peripheral nerve stimulation
Amplitudes of event related potentials
ERP during stimulation
Measured: during tDCS
Amplitudes of event related potentials
ERP during stimulation
Measured: during peripheral nerve stimulation
Pupil dilations
pupil diameter during stimulation
Measured: during peripheral nerve stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Sep 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for tDCS MechanismsStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myles Mc Laughlin, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577677
- Sponsor's protocol ID
- S63709
- Status last verified
- Aug 2024
- First submitted
- 28 Sep 2020
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Seminck N, Van Bogaert T, Kilic U, Nuttin B, Mc Laughlin M. External Trigeminal Nerve Stimulation Evokes Bilateral Electroencephalography Responses and Modulates Spectral Power in Healthy Adults. Neuromodulation. 2026 Jun;29(4):551-562. doi: 10.1016/j.neurom.2025.11.002. Epub 2025 Dec 27.
PubMed 41454900Kerstens S, Orban de Xivry JJ, Mc Laughlin M. A novel tDCS control condition using optimized anesthetic gel to block peripheral nerve input. Front Neurol. 2022 Nov 14;13:1049409. doi: 10.3389/fneur.2022.1049409. eCollection 2022.
PubMed 36452171
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Neural Mechanisms Behind Transcranial Direct Current Stimulation
- ClinicalTrials.gov ID
- NCT04577677
- Acronym / sponsor ID
- S63709
- Conditions
- tDCS Mechanisms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Oct 2020 (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.
The aim of the study is to investigate the neural mechanisms underpinning transcranial direct current stimulation (tDCS), a non-invasive neuromodulation technique in which a direct current is passed through scalp electrodes. A series of experiments will be conducted to understand and characterize the transcranial and transcutaneous mechanisms of tDCS. To investigate this research question, every participant will undergo three stimulation conditions (active, sham and control). In the control condition, an anaesthetic cream will be applied to anaesthetize the nerves in the scalp. In addition, the effectiveness of tDCS and peripheral nerve stimulation will be compared. Ultimately, the obtained knowledge can lead to the development of improved non-invasive neuromodulation therapies, which can lead to more effective treatments of a variety of neurological and psychiatric disorders.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| optimization of control anesthetic condition | Experimental | Device: brain stimulation |
| understanding tDCS effect on motor learning | Experimental | Device: brain stimulation |
| understanding tDCS effects on cortical excitability | Experimental | Device: brain stimulation |
| optimizing peripheral nerve stimulation protocols | Experimental | Device: brain stimulation |
| Effect peripheral nerve stimulation on motor learning | Experimental | Device: brain stimulation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- good general health
Key exclusion criteria (19 listed)
- Epilepsy or family history of epilepsy
- Migraine
- Allergic to lidocaine or benzocaine
- Pregnant
- History of or currently suffering from:
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 |
|---|---|---|
| brain stimulationAlso: skin interventiontDCS and peripheral nerve stimulation | Device | Effect peripheral nerve stimulation on motor learning, optimization of control anesthetic condition, optimizing peripheral nerve stimulation protocols, understanding tDCS effect on motor learning, understanding tDCS effects on cortical excitability |
Primary outcome
Visual Analogue Scale
Time frame: 30 minutes during stimulation
Rate sensation from 0 ('I feel nothing') to 10 ('Stimulation is painful')
Reaction time
Time frame: 20 minutes during tDCS stimulation
Reaction time on the motor learning task
Reaction time
Time frame: 20 minutes during peripheral nerve stimulation
Reaction time on motor learning task
Amplitudes of event related potentials
Time frame: during tDCS
ERP during stimulation
Amplitudes of event related potentials
Time frame: during peripheral nerve stimulation
ERP during stimulation
Pupil dilations
Time frame: during peripheral nerve stimulation
pupil diameter during stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Derived from this study: PubMed 41454900Seminck N, Van Bogaert T, Kilic U, Nuttin B, Mc Laughlin M. External Trigeminal Nerve Stimulation Evokes Bilateral Electroencephalography Responses and Modulates Spectral Power in Healthy Adults. Neuromodulation. 2026 Jun;29(4):551-562. doi: 10.1016/j.neurom.2025.11.002. Epub 2025 Dec 27.
- Derived from this study: PubMed 36452171Kerstens S, Orban de Xivry JJ, Mc Laughlin M. A novel tDCS control condition using optimized anesthetic gel to block peripheral nerve input. Front Neurol. 2022 Nov 14;13:1049409. doi: 10.3389/fneur.2022.1049409. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brain stimulation in people with tDCS Mechanisms, run by KU Leuven 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 19 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: status not confirmed, as of the sponsor's last update on 30 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myles Mc Laughlin, professor (+32 16 32 43 48, myles.mclaughlin@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 30 minutes during stimulation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04577677, which also lists 2 linked publications.
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 30 Aug 2024.