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

Brain Stimulation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04148547
• Other study ID #: uammadrid4
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: October 2019
• Source: Universidad Autonoma de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 30, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Basic Physiology
• Brain Stimulation

Intervention

Device:
• Sooma transcranial direct current stimulation device
This group received brain training through transcranial direct current for 20 minutes.
• 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.

Locations

Country	Name	City	State
Spain	CSEU La Salle	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Autonoma de Madrid	Centro Universitario La Salle

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure pain threshold through an algometer	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
Primary	Tactile acuity threshold	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
Primary	Muscle recruitment through electromyographic activity	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