NCT04577677

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

September 1, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 30, 2024

Status Verified

August 1, 2024

Enrollment Period

4.3 years

First QC Date

September 28, 2020

Last Update Submit

August 29, 2024

Conditions

tDCS Mechanisms

Outcome Measures

Primary Outcomes (6)

  • Visual Analogue Scale

    Rate sensation from 0 ('I feel nothing') to 10 ('Stimulation is painful')

    30 minutes during stimulation

  • Reaction time

    Reaction time on the motor learning task

    20 minutes during tDCS stimulation

  • Reaction time

    Reaction time on motor learning task

    20 minutes during peripheral nerve stimulation

  • Amplitudes of event related potentials

    ERP during stimulation

    during tDCS

  • Amplitudes of event related potentials

    ERP during stimulation

    during peripheral nerve stimulation

  • Pupil dilations

    pupil diameter during stimulation

    during peripheral nerve stimulation

Study Arms (5)

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

Interventions

brain stimulationDEVICE

tDCS and peripheral nerve stimulation

Also known as: skin intervention
Effect peripheral nerve stimulation on motor learningoptimization of control anesthetic conditionoptimizing peripheral nerve stimulation protocolsunderstanding tDCS effect on motor learningunderstanding tDCS effects on cortical excitability

Eligibility Criteria

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

You may qualify if:

  • good general health

You may not qualify if:

  • Epilepsy or family history of epilepsy
  • Migraine
  • Allergic to lidocaine or benzocaine
  • Pregnant
  • History of or currently suffering from:
  • neurological diseases
  • 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:
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KULeuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Related Publications (2)

  • 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. 2025 Dec 26:S1094-7159(25)01146-8. doi: 10.1016/j.neurom.2025.11.002. Online ahead of print.

    PMID: 41454900DERIVED

  • Kerstens 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.

    PMID: 36452171DERIVED

MeSH Terms

Interventions

Deep Brain Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Central Study Contacts

Myles Mc Laughlin, professor

CONTACT

+32 16 32 43 48myles.mclaughlin@kuleuven.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 8, 2020

Study Start

September 1, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

August 30, 2024

Record last verified: 2024-08

Locations

BE(1)