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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Pain Modulation
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: transcranial direct current plus Brain training tools; 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; This group will carry out an observation training of actions and motor imagery in combination with the stimulation of the transcranial direct current.
Placebo Comparator: Placebo transcranial direct current plus 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.	Device: 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.
Sham Comparator: 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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Madrid
• Collaborators: Centro Universitario La Salle

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Transcranial direct current stimulation; Motor imagery; Action observation
• Other Study ID Numbers: uammadrid

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