Understanding the Neural Mechanisms Behind tDCS

August 29, 2024 updated by: Myles Mc Laughlin, KU Leuven

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: optimization of control anesthetic condition
Device: brain stimulation
tDCS and peripheral nerve stimulation
Other Names:
  • skin intervention
Experimental: understanding tDCS effect on motor learning
Device: brain stimulation
tDCS and peripheral nerve stimulation
Other Names:
  • skin intervention
Experimental: understanding tDCS effects on cortical excitability
Device: brain stimulation
tDCS and peripheral nerve stimulation
Other Names:
  • skin intervention
Experimental: optimizing peripheral nerve stimulation protocols
Device: brain stimulation
tDCS and peripheral nerve stimulation
Other Names:
  • skin intervention
Experimental: Effect peripheral nerve stimulation on motor learning
Device: brain stimulation
tDCS and peripheral nerve stimulation
Other Names:
  • skin intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: 30 minutes during stimulation
Rate sensation from 0 ('I feel nothing') to 10 ('Stimulation is painful')
30 minutes during stimulation
Reaction time
Time Frame: 20 minutes during tDCS stimulation
Reaction time on the motor learning task
20 minutes during tDCS stimulation
Reaction time
Time Frame: 20 minutes during peripheral nerve stimulation
Reaction time on motor learning task
20 minutes during peripheral nerve stimulation
Amplitudes of event related potentials
Time Frame: during tDCS
ERP during stimulation
during tDCS
Amplitudes of event related potentials
Time Frame: during peripheral nerve stimulation
ERP during stimulation
during peripheral nerve stimulation
Pupil dilations
Time Frame: during peripheral nerve stimulation
pupil diameter during stimulation
during peripheral nerve stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 28, 2020

First Submitted That Met QC Criteria

October 2, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

August 30, 2024

Last Update Submitted That Met QC Criteria

August 29, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • S63709

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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