Cognitive ChangeNCT04621162
Effects of Expectations on Hypoalgesia Produced by Mental Practice
A study testing Positive Expectations (initial), Negative Expectations (initial) and Neutral Expectations (initial) in people with Cognitive Change, run by Universidad Autonoma de Madrid at 1 site in Spain.
Trial summary
The main objective of this research work is to evaluate and quantify the hypoalgesia generated by motor imagery influenced by the presence of expectations. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- Positive Expectations (initial), Negative Expectations (initial) and Neutral Expectations (initial)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 30 Dec 2020to 30 Jul 2021
- 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
- Age between 18 and 60
- Healthy and with no pain subjects
Who cannot join
- Any cognitive impairment that hindered viewing of audiovisual material.
- Difficulty understanding or communicating.
- Presence of systemic pathology, Central Nervous System or rheumatic disease.
- Inadequate understanding of the Spanish language to follow instructions for measuring and treatment.
- Collaboration of pregnant women.
- Underage subjects
- Subjects with pain at the time of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Influence of Cognitive Variables in Hypoalgesia Generated by Motor Imagery: A Randomized Controlled Trial
The main objective of this research work is to evaluate and quantify the hypoalgesia generated by motor imagery influenced by the presence of expectations.
- Conditions
- Cognitive Change
- Being tested
- Positive Expectations (initial), Negative Expectations (initial), Neutral Expectations (initial), Positive Expectations (during intervention), Experimental: Negative Expectations (during intervention)
- Keywords
- Motor imagery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Expectations (initial)Behavioural
A positive expectation of the effect of motor imagery will be given before beginning the mental practice of imagination. "This task will generate hypoalgesia"
Negative Expectations (initial)Behavioural
A negative expectation of the effect of motor imagery will be given before beginning the mental practice of imagination. "This task will not generate hypoalgesia"
Neutral Expectations (initial)Behavioural
This group will act as a control. No expectations will be given that will influence the participant.
Positive Expectations (during intervention)Behavioural
A positive expectation will be given during the performance of the mental practice. "This is working very well"
Experimental: Negative Expectations (during intervention)Behavioural
A negative expectation will be given during the performance of the mental practice. "This is working very bad"
Neutral Expectations (during intervention)Behavioural
This group will act as a control. No expectations will be given that will influence the participant.
| Study group | Role | What they receive |
|---|---|---|
| Positive Expectations (initial) | Experimental | Not described Receives: Behavioral: Positive Expectations (initial) |
| Negative Expectations (initial) | Experimental | Not described Receives: Behavioral: Negative Expectations (initial) |
| Neutral Expectations (initial) | Placebo comparator | Not described Receives: Behavioral: Neutral Expectations (initial) |
| Positive Expectations (during intervention) | Experimental | Not described Receives: Behavioral: Positive Expectations (during intervention) |
| Negative Expectations (during intervention) | Experimental | Not described Receives: Behavioral: Experimental: Negative Expectations (during intervention) |
| Neutral Expectations (during intervention) | Placebo comparator | Not described Receives: Behavioral: Neutral Expectations (during intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain pressure threshold
Pressure Pain Threshold (PPT) is one of these tests and it is defined as the minimum force applied which induces pain. The measurement shall be carried out by using an algometer (pressure device that induces mechanical stimuli) is to standardize the amount of pressure applied in the neck region. The reliability of pressure pain thresholds according to raters or measurement frequencies is relatively high.
Measured: Change from baseline and immediately post-intervention
Thermal threshold
This variable will evaluate three aspects. Cold detection threshold, heat detection threshold and heat pain threshold. A specialized and validated instrument is used which consists of a sensor with a resistance that raises and lowers the temperature in a controlled way between 20 and 50ºC.
Measured: Change from baseline and immediately post-intervention
Heart Rate
Heart Rate will be measured by three electrodes located in the left area of the chest. One of the electrodes is placed in the middle zone while a second electrode is positioned on the lateral side, and a third one on the lower left side, below the first electrode.
Measured: Change from baseline and immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start30 Dec 2020 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 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
- NCT04621162
- Sponsor's protocol ID
- uammadrid100
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Influence of Cognitive Variables in Hypoalgesia Generated by Motor Imagery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04621162
- Acronym / sponsor ID
- uammadrid100
- Conditions
- Cognitive Change
- Keywords
- Motor imagery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Collaborators
- Centro Universitario La Salle
- Study start
- 30 Dec 2020 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 9 Nov 2020 (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 work is to evaluate and quantify the hypoalgesia generated by motor imagery influenced by the presence of expectations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Positive Expectations (initial) | Experimental | Behavioral: Positive Expectations (initial) |
| Negative Expectations (initial) | Experimental | Behavioral: Negative Expectations (initial) |
| Neutral Expectations (initial) | Placebo comparator | Behavioral: Neutral Expectations (initial) |
| Positive Expectations (during intervention) | Experimental | Behavioral: Positive Expectations (during intervention) |
| Negative Expectations (during intervention) | Experimental | Behavioral: Experimental: Negative Expectations (during intervention) |
| Neutral Expectations (during intervention) | Placebo comparator | Behavioral: Neutral Expectations (during intervention) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 and 60
- Healthy and with no pain subjects
Key exclusion criteria (7 listed)
- Any cognitive impairment that hindered viewing of audiovisual material.
- Difficulty understanding or communicating.
- Presence of systemic pathology, Central Nervous System or rheumatic disease.
- Inadequate understanding of the Spanish language to follow instructions for measuring and treatment.
- Collaboration of pregnant women.
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 |
|---|---|---|
| Positive Expectations (initial)A positive expectation of the effect of motor imagery will be given before beginning the mental practice of imagination. "This task will generate hypoalgesia" | Behavioural | Positive Expectations (initial) |
| Negative Expectations (initial)A negative expectation of the effect of motor imagery will be given before beginning the mental practice of imagination. "This task will not generate hypoalgesia" | Behavioural | Negative Expectations (initial) |
| Neutral Expectations (initial)This group will act as a control. No expectations will be given that will influence the participant. | Behavioural | Neutral Expectations (initial) |
| Positive Expectations (during intervention)A positive expectation will be given during the performance of the mental practice. "This is working very well" | Behavioural | Positive Expectations (during intervention) |
| Experimental: Negative Expectations (during intervention)A negative expectation will be given during the performance of the mental practice. "This is working very bad" | Behavioural | Negative Expectations (during intervention) |
| Neutral Expectations (during intervention)This group will act as a control. No expectations will be given that will influence the participant. | Behavioural | Neutral Expectations (during intervention) |
Primary outcome
Pain pressure threshold
Time frame: Change from baseline and immediately post-intervention
Pressure Pain Threshold (PPT) is one of these tests and it is defined as the minimum force applied which induces pain. The measurement shall be carried out by using an algometer (pressure device that induces mechanical stimuli) is to standardize the amount of pressure applied in the neck region. The reliability of pressure pain thresholds according to raters or measurement frequencies is relatively high.
Thermal threshold
Time frame: Change from baseline and immediately post-intervention
This variable will evaluate three aspects. Cold detection threshold, heat detection threshold and heat pain threshold. A specialized and validated instrument is used which consists of a sensor with a resistance that raises and lowers the temperature in a controlled way between 20 and 50ºC.
Heart Rate
Time frame: Change from baseline and immediately post-intervention
Heart Rate will be measured by three electrodes located in the left area of the chest. One of the electrodes is placed in the middle zone while a second electrode is positioned on the lateral side, and a third one on the lower left side, below the first electrode.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Expectations (initial), Negative Expectations (initial) and Neutral Expectations (initial) in people with Cognitive Change, 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 7 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 9 Nov 2020. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain pressure threshold (time frame: Change from baseline and immediately post-intervention). The study lists 3 primary outcomes in all. 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 9 Nov 2020.