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Placebo EffectNCT06835777

Neurophysiological Mechanisms of Placebo and Nocebo Effects in Sports - a Protocol Paper

A study testing Positive Expectation and Negative Expectation in people with Placebo Effect and Nocebo Effect, run by Canterbury Christ Church University at 1 site in United Kingdom.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This clinical trial aims to investigate the neurophysiological mechanisms of placebo and nocebo effects on sports performance, using Electroencephalography (EEG) and isometric strength testing of the lower extremities. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Placebo Effect, Nocebo Effect
What is being tested?
Positive Expectation and Negative Expectation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUnited Kingdom
Study dates
1 Mar 2025to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy adult participants (18+)
  • physically active (WHO, 2020)
  • no medical history pf psychological disorders/mental health issues
  • no acute or regular medication intake
  • no severe injury to the lower limb within the last 6 months
  • proficient in english
  • normal or corrected eyesight

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Janina Hanssen, M.Sc. contact

07553606641

JH1718@canterbruy.ac.uk

United Kingdom1 site
  • Canterbury Christ Church University

    Canterbury, Kent, CT1 1QU

Other trials in United Kingdom

About this study

Official title: Neurophysiological Mechanisms of Placebo and Nocebo Effects in Sports - Protocol Paper of a Randomised Controlled Study

This clinical trial aims to investigate the neurophysiological mechanisms of placebo and nocebo effects on sports performance, using Electroencephalography (EEG) and isometric strength testing of the lower extremities.

The primary objective of this trial is to identify temporal mechanisms and cortical regions and networks involved in generating placebo and nocebo effects before (expectation) and at onset of athletic performance (perception).

The trial will include four groups, two of them experimental, one an active control and one natural history, meaning participants in this group will receive no intervention and won't be EEG controlled. Data will be collected on two occasions with baseline data for EEG, expectations and performance as well as key participant characteristics being collected on day one. On day two, in a deceptive process, participants in the two experimental groups will take an inert substance presented as either performance enhancing or inhibiting and subsequently experience a reinforcement of beliefs via exposure to explicit adjectives. EEG data will be collected during reinforcement of beliefs. In the active control group, participants will receive no substance, but this group will follow the same procedure as the experimental groups with neutral adjectives. Participants will then perform isometric strength and fatigue resistance tests on an isometric dynamometer. EEG data as well as subjective data on expectations and rating of perceived exhaustion will be collected.

Read the detailed description

This trial will examine temporal and spatial aspects of neurophysiological mechanisms behind nocebo and placebo effects before (expectation) and at exercise onset (perception) using high-density EEG. It will further investigate possible predictors of responsiveness and non-responsiveness to acute placebo and nocebo stimuli in the context of sports, notably interpretating psychological mechanisms (e.g. personality, beliefs, expectations) as well as temporal neurophysiological measures.

This study is designed as a randomized, controlled clinical trial (RCT) with data collection on two different occasions and four parallel groups: 1) positive-expectations, 2) negative-expectations, 3) control, and 4) natural history.

The first three groups will be addressed as intervention groups. On the first visit, participants' baseline data, specifically performance measures (all groups) and EEG data (all but natural history), as well as key characteristics will be collected. On the second visit, in the belief groups, participants will receive an in-person manipulation of beliefs and two placebo pills and will be informed that they are expected to positively (positive-expectations) or negatively (negative-expectations) affect their isometric strength and fatigue resistance measured using a Biodex System 4 Isokinetic Dynamometer in a 5x5sec test protocol with a minimum of 1 minute rest in between sets. In addition, after a resting period of three minutes, they will perform an isometric knee extension hold to failure at 60% MVC. The control group and the natural history group will receive no pills, with the control group receiving a neutral explanation of EEG data, its relevance and general information about isometric strength testing and the natural history group not receiving EEG at all, but serving as a control to the potential influence of experiencing an EEG set up on performance measures. The primary endpoints of this trial are placebo and nocebo induced changes in EEG signaling via Event Related Potentials (ERPs) during administration of reinforcements of beliefs through words as well as during expectancy and perception phases of physical performance.

The key question of this trial is whether participants exposed to placebo or nocebo stimuli will exhibit distinct neural activity pattern (temporal and spatial) in the context of sports performance. The second major question is, whether individual differences in character traits and states as well as motivation and beliefs can significantly predict the magnitude or likeliness of placebo and nocebo responses in participants' performance in an isometric strength and fatigue resistance task. In addition, EEG data to better understand the valence of and emotional response to words will be used to further investigate how semantics and our choice of words influence susceptibility to placebo and nocebo effects in other people. Several elements that were not adequately addressed in previous studies will be incorporated into this RCT:

(1) temporal and spatial aspects of neural correlates of placebo and nocebo effects in sports, (2) hard data (EEG) on how an individual reacts to semantic implications on performance and (3) correlation of subjective ratings of expectations of performance and data from neural processes associated with affective processing, emotional valence and motivation (LPP,LPC) and anticipation as well as motor preparation (CNV). To further understand the above point may result in a change on how athletes, coaches and therapists approach placebo and nocebo effects in the context of sports performance.

Being tested
Positive Expectation, Negative Expectation, Control
Keywords
EEG, Placebo, Nocebo, Sports Performance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Positive ExpectationCombination product

    The lead researcher will deliver a short presentation (8 minutes) to participants informing them about the deceptive substance, presenting it as a performance enhancing neurostimulant,. Participants will be given the opportunity to ask questions and will receive a handout of the key points of the presentation. After the presentation, participants will be set up with a high-density EEG and given two inert pills filled with cornstarch. Participants will be reminded of the performance enhancing qualities of the deceptive substance by implicit adjectives on a screen. Afterwards, experimental performance outcomes will be collected using a dynamometer.

  • Negative ExpectationCombination product

    The lead researcher will deliver a short presentation (8 minutes) to participants informing them about the deceptive substance, presenting it as a performance inhibiting neuro-depressant. Participants will be given the opportunity to ask questions and will receive a handout of the key points of the presentation. After the presentation, participants will be set up with a high-density EEG and given two inert pills filled with cornstarch. Participants will be reminded of the performance inhibiting qualities of the deceptive substance by implicit adjectives on a screen. Afterwards, experimental performance outcomes will be collected using a dynamometer.

  • ControlOther

    The lead researcher will deliver a short presentation (8 minutes) to participants informing them about EEG research and set ups and give general information about isometric strength testing. They will be shown neutral adjectives unrelated to performance instead of implicit adjectives related to performance (experimental groups). EEG set up and strength testing remains the same as the experimental groups.

Study groups in NCT06835777
Study groupRoleWhat they receive
positive-expectationsExperimentalThe positive-expectations intervention will consist of two inert pills filled with cornstarch and a manipulation of beliefs regarding the given substance and it's effects. Participants will be informed that the inert pills are neurostimulants, usually used in the context of depression and other mental health issues and that they can positively affect sports performance. Participants will be reinforced about these effects throughout testing via implicit adjectives regarding potential sensations they might experience after pill intake. Reinforcement of beliefs and subsequent strength testing will be EEG controlled.
Receives: Combination Product: Positive Expectation
negative-expectationsExperimentalThe negative-expectations intervention will consist of two inert pills filled with cornstarch and a manipulation of beliefs regarding the given substance and it's effects. Participants will be informed that the inert pills are neuro-depressants, which relieve anxiety and can negatively affect sports performance. Participants will be reinforced about these effects throughout testing via implicit adjectives regarding potential sensations they might experience after pill intake. Reinforcement of beliefs and subsequent strength testing on day two will be EEG controlled.
Receives: Combination Product: Negative Expectation
controlActive comparatorThe control intervention consists of the same testing procedure as the other intervention groups, but no pills or manipulation of beliefs will be administered. Participants will be given a neutral presentation on the testing procedure of the isometric strength testing. Neutral adjectives will be presented instead of a reinforcement of beliefs. Presentation of adjectives and subsequent strength testing will be EEG controlled.
Receives: Other: Control
natural historyNo interventionParticipants will neither receive an EEG nor any sort of intervention. They will do the isometric strength testing on two different occasions like the other groups and will not receive any sort of manipulation of beliefs.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EEG data - performance

    Temporal neurophysiological data measured by EEG. The Continuous Negative Variation (CNV), an Event Related Potential (ERP), will be used to differentiate positive and negative expectations as well as motor preparation before and at onset of isometric strength testing.

    Measured: From collection of baseline data on day one to the end of day two of data collection.

  2. EEG data - reinforcement of beliefs

    Event related potentials (ERP) will be investigated during the reinforcement of beliefs, specifically the late positive potential (LPP) and the late positive component (LPC).

    Measured: From collection of baseline data on day one to the end of day two of data collection.

  3. EEG, exploratory source analysis

    In addition to ERP data, Low-Resolution Electromagnetic Tomography (LORETA) will be used in an exploratory approach to identify specific neural origins associated with placebo and nocebo responses.

    Measured: From collection of baseline data on day one to the end of day two of data collection

Secondary outcomes (7)
  1. Performance Output, Isometric Forces

    Peak Isometric Force: Measured in Newton-meters (Nm) as the maximum force output during a 5-second unilateral knee extension contraction.

    Average Isometric Force: Calculated as the mean force output in Nm maintained over a 5-second unilateral knee extension contraction.

    Isometric Force output data will be analysed in a within and between analysis, the latter being normalized to body mass (Nm/kg).

    Measured: From collection of baseline data on day one to the end of day two of data collection.

  2. Performance Output, Force Consistency

    Force Consistency:

    Assessed by comparing peak and average force outputs in Nm across five consecutive trials of 5-second contractions.

    Measured: From collection of baseline data on day one to the end of day two of data collection.

  3. Performance Output, Endurance Hold and Fatigue Resistance

    Fatigue Resistance and Endurance Hold:

    Evaluating the time to failure at the 60% maximally voluntary contraction (MVC) hold.

    Measured: From collection of baseline data on day one to the end of day two of data collection.

  4. Performance Output, Recovery Capacity

    Recovery Capacity:

    Determined by examining the ability to maintain force output in Nm across trials with 1-minute rest intervals between contractions.

    Measured: From collection of baseline data on day one to the end of day two of data collection.

  5. Heartrate

    Heartrate (bpm) will be collected during and before physical performance as well as during EEG data collection.

    Measured: From collection of baseline data on day one to the end of day two of data collection.

  6. Rate of Perceived Exertion (RPE)

    Rate of perceived exertion (RPE) will be used to assess subjective effort and closeness to failure after isometric strength testing

    Measured: From collection of baseline data on day one to the end of day two of data collection.

  7. Electromyographic (EMG) Data

    EMG data of the M. vastus lateralis of the dominant leg during isometric performance tests will be collected.

    Measured: From collection of baseline data on day one to the end of day two of data collection.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2025
  2. Study start1 Mar 2025 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
Model description
randomised controlled trail, four parallel arms (positive-expectations, negative-expectations, control , natural history)
Masking
Single blind
Who is masked
Participant
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06835777
Sponsor's protocol ID
ETH2324-0198
Status last verified
Feb 2025
First submitted
10 Feb 2025
Last updated
19 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Positive Expectation and Negative Expectation in people with Placebo Effect and Nocebo Effect, run by Canterbury Christ Church University at 1 site in United Kingdom.

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 7 inclusion and 0 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: opening soon, as of the sponsor's last update on 19 Feb 2025. 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 United Kingdom. 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. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Janina Hanssen, M.Sc. (07553606641, JH1718@canterbruy.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EEG data - performance (time frame: From collection of baseline data on day one to the end of day two of data collection.). 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 19 Feb 2025.

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