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

October 14, 2019 updated by: Roy La Touche Arbizu, Universidad Autonoma de Madrid

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pressure pain threshold
Time Frame: 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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ability to generate motor images
Time Frame: 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.
Just before the start of the intervention
Mental Chronometry
Time Frame: 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
Just before the start of the intervention
The degree of physical activity
Time Frame: 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
Just before the start of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Autonoma de Madrid

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centro Universitario La Salle

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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