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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Pain Modulation

Intervention / Treatment
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* Device: Sooma transcranial direct current stimulation device plus Brain training tools
* Device: Placebo Sooma transcranial direct current stimulation deviceplus Brain training tools
* Behavioral: Brain training tools in isolation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transcranial direct current plus Brain training tools<br>20 minutes of transcranial direct current stimulation along with the application of motor imagery and action observation | Device: Sooma transcranial direct current stimulation device plus Brain training tools<br>* This group will carry out an observation training of actions and motor imagery in combination with the stimulation of the transcranial direct current.<br>|
| Placebo Comparator: Placebo transcranial direct current plus Brain training tools<br>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. | Device: Placebo Sooma transcranial direct current stimulation deviceplus Brain training tools<br>* 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.<br>|
| Sham Comparator: Brain training tools in isolation<br>This group will act as a control, they will only carry out the training of action observation and motor imagery. | Behavioral: Brain training tools in isolation<br>* This group will act as a control, they will only carry out the training of action observation and motor imagery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motor imagery, Transcranial direct current stimulation, Action observation