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Clinical Trials/NCT04577677
NCT04577677
Recruiting
Not Applicable

Understanding the Neural Mechanisms Behind Transcranial Direct Current Stimulation

KU Leuven1 site in 1 country130 target enrollmentSeptember 1, 2020
ConditionstDCS Mechanisms

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
tDCS Mechanisms
Sponsor
KU Leuven
Enrollment
130
Locations
1
Primary Endpoint
Visual Analogue Scale
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
December 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
KU Leuven
Responsible Party
Principal Investigator
Principal Investigator

Myles Mc Laughlin

Professor

KU Leuven

Eligibility Criteria

Inclusion Criteria

  • good general health

Exclusion Criteria

  • Epilepsy or family history of epilepsy
  • Allergic to lidocaine or benzocaine
  • 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

Outcomes

Primary Outcomes

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 peripheral nerve stimulation

Reaction time on motor learning task

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

Study Sites (1)

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