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OpenTrials
Completed

NCT Number: NCT04148547

Transcranial Direct Current Stimulation (tDCS) in the Primary Motor Cortex in Healthy Individuals

The main aim of this study is to assess the short-term effects of active-tDCS (a-tDCS) on the M1 regarding sensorimotor variables such as discriminative sensation, pressure pain threshold and electromyographic activity compared with a sham-tDCS (s-tDCS) in healthy individuals. The main objective was to determine whether there were clinically relevant changes generated by tDCS and if they were superior to a sham intervention.

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Key information

Conditions

Basic Physiology Brain Stimulation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CSEU La Salle

Madrid, 28023, Spain

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • asymptomatic participants
  • men and women aged 18 to 65 years

Exclusion criteria

  • insomnia
  • nausea
  • headache
  • pregnancy
  • use of painkillers in the last 24 hours
  • presence of metal inside the head
  • pacemaker
  • wound on the area of electrodes' application
  • drug consumption; (j) recent application of tDCS
  • psychiatric disease impeding understanding of the study.

Treatment and study plan

Sooma transcranial direct current stimulation device

Device

This group received brain training through transcranial direct current for 20 minutes.

Placebo Sooma transcranial direct current stimulation device

Device

This group received sham brain training through transcranial direct current for 20 minutes. The current is active for 15 seconds and then switches off until the intervention is finished.

Primary outcomes

  1. Pressure pain threshold through an algometer

    Time frame: Change in pressure pain threshold immediately at the end of the intervention

    Pressure pain threshold has been defined as the minimal amount of pressure at which a sense of pressure first changes to pain or discomfort

  2. Tactile acuity threshold

    Time frame: Change in tactile acuity threshold immediately at the end of the intervention

    Tactile acuity threshold is an important variable to know the somatosensory state and Von Frey monofilaments and Aesthesiometer were used

  3. Muscle recruitment through electromyographic activity

    Time frame: Change in electromyographic activity immediately at the end of the intervention

    The activity of surface electromyography (sEMG) during an isometric maximal voluntary contraction was measured in the biceps brachii and rectus femoris.

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Madrid

Other

Collaborators

  • Centro Universitario La Salle

Registry information

Official study title

Transcranial Direct Current Stimulation (tDCS) in the Primary Motor Cortex and Its Effects on Sensitivity, Pressure Pain Threshold, and Electromyographic Activity in Healthy Individuals: A Quasi-experimental Single-blind Sham-controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 1, 2019
Registry last updated
Nov 5, 2019

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.

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