Evaluation of the Hypoalgesic Effects of Transcranial Direct Current (tDCS) in Healthy Subjects

Not Applicable

• Conditions: Pain Modulation
• Interventions: Behavioral: Brain training tools in isolation; Device: Sooma transcranial direct current stimulation device plus Brain training tools; Device: Placebo Sooma transcranial direct current stimulation deviceplus Brain training tools

• Registration Number: NCT04127253
• Lead Sponsor: Universidad Autonoma de Madrid

Brief Summary

The main objective of this research is to evaluate and quantify hypoalgesic effects caused by imagination and observation with or without the presence of transcranial direct current (tDCS) in healthy participants. The secondary objective of this research is to evaluate the possible relationships between hypoalgesic effects and different physical and cognitive variables such as the ability to generate motor mental images, mental chronometry and levels of physical activity.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-14
• Last Update Submitted: 2019-10-14
• Study First Posted: 2019-10-15
• Last Update Posted: 2019-10-15
• Study Start: 2020-01-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

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

Exclusion Criteria

• insomnia
• nausea
• headache
• pregnant woman
• use of painkillers in the last twenty four hours
• presence of metal inside the head
• pacemaker
• wound on the area of electrodes' application
• drugs consumer
• recent application of transcranial direct stimulation
• psychiatric disease who lead the subject to a misunderstand of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brain training tools in isolation	Brain training tools in isolation	This group will act as a control, they will only carry out the training of action observation and motor imagery.
transcranial direct current plus Brain training tools	Sooma transcranial direct current stimulation device plus Brain training tools	20 minutes of transcranial direct current stimulation along with the application of motor imagery and action observation
Placebo transcranial direct current plus Brain training tools	Placebo Sooma transcranial direct current stimulation deviceplus Brain training tools	A placebo intervention of direct transcranial stimulation being active during 15 seconds and then it will be turned off the rest of the time until 20 minutes. This group will also carry out the training of action observation and motor imagery.

Primary Outcome Measures

Name	Time	Method
Pressure pain threshold	Change in Pressure pain threshold just before the start of the intervention, immediately at the end of the intervention and 15 minutes after 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

Secondary Outcome Measures

Name	Time	Method
Ability to generate motor images	Just before the start of the intervention	The ability to generate motor images will be measured through The movement imagery questionnaire-revised (MIQ-R) is an 8-item self-report inventory that was used to assess visual and kinesthetic motor imagery ability. Four different movements are included in the MIQ-R, which is comprised of 4 visual and 4 kinesthetic items. For each item, participants read a description of the movement. They then physically performed the movement and were instructed to reassume the starting position after finishing the movement and before performing the mental task, imagining the movement visually or kinesthetically. Each participant then rated the ease or difficulty of mentally generating that image on a 7-point scale, in which 7 indicates "very easy to see/feel" and 1 "very difficult to see/feel." The internal consistencies of the MIQ-R have been consistently adequate.
Mental Chronometry	Just before the start of the intervention	Mental chronometry is a reliable measure that has been widely used to record objective measurements of the ability to create mental motor images
The degree of physical activity	Just before the start of the intervention	The level of physical activity will be assessed using the International Physical Activity Questionnaire, which allows the participants to be divided into 3 groups according to their level of activity, which can be high, moderate, and low or inactive

Trial Locations

Locations (1)

CSEU La Salle; 🇪🇸 Madrid, Spain