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NCT Number: NCT04577677

Understanding the Neural Mechanisms Behind tDCS

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KULeuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location status: Recruiting

Location contact

Myles Mc Laughlin, professor

CONTACT

[email protected]

+32 16 32 43 48

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • good general health

Exclusion criteria

  • 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:
  • Defibrillator, implanted medication pump
  • Metal prosthesis in ear, hart, …
  • Deep brain stimulator
  • Coronary bypass or intracranial or aneurysm clips (brain arteries, aorta, etc.)

Treatment and study plan

brain stimulation

Device

tDCS and peripheral nerve stimulation

Other names: skin intervention

Primary outcomes

  1. Visual Analogue Scale

    Time frame: 30 minutes during stimulation

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

  2. Reaction time

    Time frame: 20 minutes during tDCS stimulation

    Reaction time on the motor learning task

  3. Reaction time

    Time frame: 20 minutes during peripheral nerve stimulation

    Reaction time on motor learning task

  4. Amplitudes of event related potentials

    Time frame: during tDCS

    ERP during stimulation

  5. Amplitudes of event related potentials

    Time frame: during peripheral nerve stimulation

    ERP during stimulation

  6. Pupil dilations

    Time frame: during peripheral nerve stimulation

    pupil diameter during stimulation

Study contacts

Contact information is provided by the study sponsor or research team.

Myles Mc Laughlin, professor

CONTACT

[email protected]

+32 16 32 43 48

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

Understanding the Neural Mechanisms Behind Transcranial Direct Current Stimulation

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 8, 2020
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.