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

Pain Modulation Clinical Trial

Official title:

Evaluation of the Hypoalgesic Effects of Transcranial Direct Current (tDCS) in Combination With Motion Representation Tools in Healthy Subjects: a Double-blind Randomized Placebo-controlled Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04127253
• Other study ID #: uammadrid
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: July 1, 2020

Study information

• Verified date: October 2019
• Source: Universidad Autonoma de Madrid
• Contact: Roy A La Tocuhe, physiotherapist PhD
• Phone: 917401980
• Email: roylatouche[@]lasallecamous.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: July 1, 2020
• Est. primary completion date: June 1, 2020
• 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

• 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

Related Conditions & MeSH terms

• Pain Modulation

Intervention

Device:
• Sooma transcranial direct current stimulation device plus Brain training tools
This group will carry out an observation training of actions and motor imagery in combination with the stimulation of the transcranial direct current.
• Placebo Sooma transcranial direct current stimulation deviceplus Brain training tools
This group will carry out an observation training of actions and motor imagery in combination with the placebo stimulation of the transcranial direct current, where it will be acrtivo during 15 seconds and then it will be turned off during the rest of the intervention.

Behavioral:
• 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.

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	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 just before the start of the intervention, immediately at the end of the intervention and 15 minutes after the end of the intervention
Secondary	Ability to generate motor images	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.	Just before the start of the intervention
Secondary	Mental Chronometry	Mental chronometry is a reliable measure that has been widely used to record objective measurements of the ability to create mental motor images	Just before the start of the intervention
Secondary	The degree of physical activity	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	Just before the start of the intervention