NCT04127253

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

5 months

First QC Date

October 10, 2019

Last Update Submit

October 14, 2019

Conditions

Pain Modulation

Keywords

Motor imageryTranscranial direct current stimulationAction observation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Ability to generate motor images

    Just before the start of the intervention

  • Mental Chronometry

    Just before the start of the intervention

  • The degree of physical activity

    Just before the start of the intervention

Study Arms (3)

transcranial direct current plus Brain training tools

EXPERIMENTAL

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

Placebo transcranial direct current plus Brain training tools

PLACEBO COMPARATOR

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

Brain training tools in isolation

SHAM COMPARATOR

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

Interventions

Sooma transcranial direct current stimulation device plus Brain training toolsDEVICE

This group will carry out an observation training of actions and motor imagery in combination with the stimulation of the transcranial direct current.

transcranial direct current plus Brain training tools
Placebo Sooma transcranial direct current stimulation deviceplus Brain training toolsDEVICE

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.

Placebo transcranial direct current plus Brain training tools
Brain training tools in isolationBEHAVIORAL

This group will act as a control, they will only carry out the training of action observation and motor imagery.

Brain training tools in isolation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CSEU La Salle

Madrid, 28023, Spain

Location

Central Study Contacts

Roy A La Tocuhe, physiotherapist PhD

CONTACT

917401980roylatouche@lasallecamous.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 15, 2019

Study Start

January 1, 2020

Primary Completion

June 1, 2020

Study Completion

July 1, 2020

Last Updated

October 15, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)