Pain ModulationNCT04127253
Evaluation of the Hypoalgesic Effects of Transcranial Direct Current (tDCS) in Healthy Subjects
A study testing Sooma transcranial direct current stimulation device plus Brain training tools and Brain training tools in isolation in people with Pain Modulation, run by Universidad Autonoma de Madrid at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Modulation
- What is being tested?
- Sooma transcranial direct current stimulation device plus Brain training tools and Brain training tools in isolation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2020to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- asymptomatic participants
- men and women aged 18 to 65 years
Who cannot join
- insomnia
- nausea
- headache
- pregnant woman
- use of painkillers in the last twenty four hours
- presence of metal inside the head
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Pain Modulation
- Being tested
- Sooma transcranial direct current stimulation device plus Brain training tools, Placebo Sooma transcranial direct current stimulation deviceplus Brain training tools, Brain training tools in isolation
- Keywords
- Motor imagery, Transcranial direct current stimulation, Action observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
Brain training tools in isolationBehavioural
This group will act as a control, they will only carry out the training of action observation and motor imagery.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: Behavioral: Brain training tools in isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 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
Measured: 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
Measured: Just before the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start1 Jan 2020 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ModulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Universitario La Salle
- Responsible party
- Principal investigator, Roy La Touche Arbizu, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127253
- Sponsor's protocol ID
- uammadrid
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04127253
- Acronym / sponsor ID
- uammadrid
- Conditions
- Pain Modulation
- Keywords
- Motor imagery, Transcranial direct current stimulation, Action observation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Collaborators
- Centro Universitario La Salle
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| transcranial direct current plus Brain training tools | Experimental | Device: Sooma transcranial direct current stimulation device plus Brain training tools20 minutes of transcranial direct current stimulation along with the application of motor imagery and action observation |
| Placebo transcranial direct current plus Brain training tools | Placebo comparator | Device: Placebo Sooma transcranial direct current stimulation deviceplus Brain training toolsA 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. |
| Brain training tools in isolation | Sham comparator | Behavioral: Brain training tools in isolationThis group will act as a control, they will only carry out the training of action observation and motor imagery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- asymptomatic participants
- men and women aged 18 to 65 years
Key exclusion criteria (11 listed)
- insomnia
- nausea
- headache
- pregnant woman
- use of painkillers in the last twenty four hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sooma transcranial direct current stimulation device plus Brain training toolsThis group will carry out an observation training of actions and motor imagery in combination with the stimulation of the transcranial direct current. | Device | transcranial direct current plus Brain training tools |
| Placebo Sooma transcranial direct current stimulation deviceplus Brain training toolsThis 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. | Device | Placebo transcranial direct current plus Brain training tools |
| Brain training tools in isolationThis group will act as a control, they will only carry out the training of action observation and motor imagery. | Behavioural | Brain training tools in isolation |
Primary outcome
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
3 secondary outcomes
Ability to generate motor images
Time frame: Just before the start of the intervention
Mental Chronometry
Time frame: Just before the start of the intervention
The degree of physical activity
Time frame: Just before the start of the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sooma transcranial direct current stimulation device plus Brain training tools and Brain training tools in isolation in people with Pain Modulation, run by Universidad Autonoma de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roy A La Tocuhe, physiotherapist PhD (917401980 ext. 313, roylatouche@lasallecamous.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.