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

October 31, 2019 updated by: Roy La Touche Arbizu, Universidad Autonoma de Madrid

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

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 Locations

  • Spain
      • Madrid, Spain, 28023
        • CSEU La Salle

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: transcranial direct current stimulation
Device: Sooma transcranial direct current stimulation device
This group received brain training through transcranial direct current for 20 minutes.
PLACEBO_COMPARATOR: Sham transcranial direct current stimulation
Device: Placebo Sooma transcranial direct current stimulation 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change in pressure pain threshold immediately at the end of the intervention
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
Change in tactile acuity threshold immediately at the end of the intervention
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.
Change in electromyographic activity immediately at the end of the intervention

Collaborators and Investigators

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

Sponsor

Universidad Autonoma de Madrid

Collaborators

Centro Universitario La Salle

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, 2018

Primary Completion (ACTUAL)

June 1, 2019

Study Completion (ACTUAL)

June 30, 2019

Study Registration Dates

First Submitted

October 30, 2019

First Submitted That Met QC Criteria

October 30, 2019

First Posted (ACTUAL)

November 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2019

Last Update Submitted That Met QC Criteria

October 31, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • uammadrid4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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