HealthyNCT04734808
EEG Brain Activity At Various Cycling Intensities
A study testing Electroencephalography and Electromyography in people with Healthy, run by Science and Research Centre Koper at 1 site in Slovenia.
Trial summary
The aim of this study is to investigate brain activity with EEG during incremental cycling at various cycling intensities. Read more about this study
- Who is it for?
- Ages 22 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Electroencephalography and Electromyography
- How many people
- 20 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Feb 2021to 15 Aug 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 22 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Heathy and recreationaly active men
- No significant muscular, skeleton or nervous system damage
- Cycloergometry test (positive)
Who cannot join
- Nervous system disorders
- Cardiovascular disorders (e.g.: high blood pressure, arrhythmia...)
- Asthma
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
University of Maribor
Maribor
Teja Licen, Ms, t.licen@gmail.com
Uros Marusic, PhD, uros.marusic@zrs-kp.si
About this study
Official title: EEG Brain Activity During A Progressive Cycling Protocol
The aim of this study is to investigate brain activity with EEG during incremental cycling at various cycling intensities.
Read the detailed description
Increases in EEG power spectra have been found during graded cycling to fatigue linking brain activity to exercise intensity. Additionally, to the activation of the classical motor control regions (e.g.: motor, somatosensory, premotor and supplementary motor cortices and cerebellum), the activation of the regions associated with autonomic regulation (i.e.: insular cortex) during exercise, as well as reduced activation of cognitive-related areas (i.e.: prefrontal cortex), an effect that increased at higher perceived intensities of cycling has been observed.
Furthermore, the precentral gyrus and cerebellar vermis, as well as brain areas (e.g.: posterior cingulate cortex (PCC) and precuneus) have been associated with higher levels of perceived exertion as well. Although the results were assessed sing a specially designed compatible fMRI cycling ergometer (Fontes et al., 2020), due to which the brain imaging techniques were limited to static (and horizontal) measurement conditions during cycling, we believe that the present study clearly distinguishes between claims proposed by different theoretical frameworks on brain responses during exercise.
Therefore, the aim of this study is to examine the brain activity with EEG during the same incremental protocol, which will allow us to investigate the functioning of surface electrocortical activation patterns during progressive cycling exercise. Furthermore, using the advanced brain image analysis (machine learning techniques and standardized low-resolution electromagnetic tomography - sLORETA) helped us determine the frequency spectrum of brain activity in the same brain areas.
- Conditions
- Healthy
- Being tested
- Electroencephalography, Electromyography
- Keywords
- EEG, Brain Imaging, Brain Waves, Cycling, Intensity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalographyDiagnostic test
Also called EEG
Electroencephalography is an electrophysiological monitoring method to record electrical activity of the brain.
ElectromyographyDiagnostic test
Also called hdEMG
Electromyography is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles. We will use the hdEMG version.
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta band suppression
Reduction of beta is one of the cortical markers which is usually obtained from the central electrodes and occurs with movement initiation.
Measured: During the intervention
Secondary outcomes (1)
Brain mapping
Analyzing the change in (de)activated "regions of interest" (ROI) of the brain between cycling during increasing exercise conditions
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 Feb 2021
- Primary completion1 Aug 2021 (estimated)
- Study completion15 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Science and Research Centre Koper
- Sponsor type
- University, hospital or other
- Collaborators
- University Maribor, University of Geneva, Switzerland
- Responsible party
- Principal investigator, Marusic, Science and Research Centre Koper
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734808
- Sponsor's protocol ID
- TwinBrainCycling
- Status last verified
- Apr 2021
- First submitted
- 22 Jan 2021
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bailey SP, Hall EE, Folger SE, Miller PC. Changes in EEG during graded exercise on a recumbent cycle ergometer. J Sports Sci Med. 2008 Dec 1;7(4):505-11. eCollection 2008.
PubMed 24149958Fontes EB, Bortolotti H, Grandjean da Costa K, Machado de Campos B, Castanho GK, Hohl R, Noakes T, Min LL. Modulation of cortical and subcortical brain areas at low and high exercise intensities. Br J Sports Med. 2020 Jan;54(2):110-115. doi: 10.1136/bjsports-2018-100295. Epub 2019 Aug 16.
PubMed 31420319Fontes EB, Okano AH, De Guio F, Schabort EJ, Min LL, Basset FA, Stein DJ, Noakes TD. Brain activity and perceived exertion during cycling exercise: an fMRI study. Br J Sports Med. 2015 Apr;49(8):556-60. doi: 10.1136/bjsports-2012-091924. Epub 2013 Jun 1.
PubMed 23729175Enders H, Cortese F, Maurer C, Baltich J, Protzner AB, Nigg BM. Changes in cortical activity measured with EEG during a high-intensity cycling exercise. J Neurophysiol. 2016 Jan 1;115(1):379-88. doi: 10.1152/jn.00497.2015. Epub 2015 Nov 4.
PubMed 26538604
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG Brain Activity During A Progressive Cycling Protocol
- ClinicalTrials.gov ID
- NCT04734808
- Acronym / sponsor ID
- TwinBrainCycling
- Conditions
- Healthy
- Keywords
- EEG, Brain Imaging, Brain Waves, Cycling, Intensity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Science and Research Centre KoperUniversity, hospital or other
- Collaborators
- University Maribor, University of Geneva, Switzerland
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 15 Aug 2021 (estimated)
- First posted
- 2 Feb 2021 (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 aim of this study is to investigate brain activity with EEG during incremental cycling at various cycling intensities.
Detailed description
Increases in EEG power spectra have been found during graded cycling to fatigue linking brain activity to exercise intensity. Additionally, to the activation of the classical motor control regions (e.g.: motor, somatosensory, premotor and supplementary motor cortices and cerebellum), the activation of the regions associated with autonomic regulation (i.e.: insular cortex) during exercise, as well as reduced activation of cognitive-related areas (i.e.: prefrontal cortex), an effect that increased at higher perceived intensities of cycling has been observed.
Furthermore, the precentral gyrus and cerebellar vermis, as well as brain areas (e.g.: posterior cingulate cortex (PCC) and precuneus) have been associated with higher levels of perceived exertion as well. Although the results were assessed sing a specially designed compatible fMRI cycling ergometer (Fontes et al., 2020), due to which the brain imaging techniques were limited to static (and horizontal) measurement conditions during cycling, we believe that the present study clearly distinguishes between claims proposed by different theoretical frameworks on brain responses during exercise.
Therefore, the aim of this study is to examine the brain activity with EEG during the same incremental protocol, which will allow us to investigate the functioning of surface electrocortical activation patterns during progressive cycling exercise. Furthermore, using the advanced brain image analysis (machine learning techniques and standardized low-resolution electromagnetic tomography - sLORETA) helped us determine the frequency spectrum of brain activity in the same brain areas.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 22 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Heathy and recreationaly active men
- No significant muscular, skeleton or nervous system damage
- Cycloergometry test (positive)
Key exclusion criteria (3 listed)
- Nervous system disorders
- Cardiovascular disorders (e.g.: high blood pressure, arrhythmia...)
- Asthma
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 |
|---|---|---|
| ElectroencephalographyAlso: EEGElectroencephalography is an electrophysiological monitoring method to record electrical activity of the brain. | Diagnostic test | – |
| ElectromyographyAlso: hdEMGElectromyography is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles. We will use the hdEMG version. | Diagnostic test | – |
Primary outcome
Beta band suppression
Time frame: During the intervention
Reduction of beta is one of the cortical markers which is usually obtained from the central electrodes and occurs with movement initiation.
1 secondary outcome
Brain mapping
Time frame: During the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Background: PubMed 24149958Bailey SP, Hall EE, Folger SE, Miller PC. Changes in EEG during graded exercise on a recumbent cycle ergometer. J Sports Sci Med. 2008 Dec 1;7(4):505-11. eCollection 2008.
- Background: PubMed 31420319Fontes EB, Bortolotti H, Grandjean da Costa K, Machado de Campos B, Castanho GK, Hohl R, Noakes T, Min LL. Modulation of cortical and subcortical brain areas at low and high exercise intensities. Br J Sports Med. 2020 Jan;54(2):110-115. doi: 10.1136/bjsports-2018-100295. Epub 2019 Aug 16.
- Background: PubMed 23729175Fontes EB, Okano AH, De Guio F, Schabort EJ, Min LL, Basset FA, Stein DJ, Noakes TD. Brain activity and perceived exertion during cycling exercise: an fMRI study. Br J Sports Med. 2015 Apr;49(8):556-60. doi: 10.1136/bjsports-2012-091924. Epub 2013 Jun 1.
- Background: PubMed 26538604Enders H, Cortese F, Maurer C, Baltich J, Protzner AB, Nigg BM. Changes in cortical activity measured with EEG during a high-intensity cycling exercise. J Neurophysiol. 2016 Jan 1;115(1):379-88. doi: 10.1152/jn.00497.2015. Epub 2015 Nov 4.
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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 Electroencephalography and Electromyography in people with Healthy, run by Science and Research Centre Koper at 1 site in Slovenia.
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 3 inclusion and 3 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 21 Apr 2021. 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 Slovenia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teja Ličen, MsC (+38656637700, teja.licen@um.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beta band suppression (time frame: During the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04734808, which also lists 4 linked publications.
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 21 Apr 2021.