Basketball PlayerNCT04939181
Non-invasive Neuromodulation NESA in Neuroefficiency in Basketball Players
A study testing Non-invasive Neuromodulation in people with Basketball Player, run by University of Las Palmas de Gran Canaria at 1 site in Spain.
Trial summary
Competitive team sports calendars are becoming increasingly compressed, generating changes in the effort-recovery cycle. Given this new situation, it seems necessary to analyze how it affects the physiological and performance level of semi-professional players, as well as how to observe if the non-invasive… Read more about this study
- Who is it for?
- Ages 18 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Basketball Player
- What is being tested?
- Non-invasive Neuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2021to 18 Nov 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 24 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Belonging to the team
- Participants do not present injury or pathology during the study
- In normal conditions and mentally competent to participate in the study.
- In condition to complete the study questionnaires.
Who cannot join
- Present some of the contraindications for a treatment with non-invasive neuromodulation: pacemakers, internal bleeding, do not apply electrodes on skin in poor condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and / or electricity phobia.
- Not having signed the informed consent.
- Present any injury or pathology during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Non-invasive Neuromodulation NESA in Neuroefficiency in Basketball Players on the Field
Competitive team sports calendars are becoming increasingly compressed, generating changes in the effort-recovery cycle. Given this new situation, it seems necessary to analyze how it affects the physiological and performance level of semi-professional players, as well as how to observe if the non-invasive neuromodulation technique NESA helps the neuroefficiency and concentration values of said players.
Read the detailed description
The design of this study is a randomised, triple blind clinical trial with placebo control.
The general configuration of the study consists of capturing the second basketball team of FC BARCELONA. For this, a double-blind capture system will be available (neither the specialist nor those responsible for recovery will know which patients are entering the complementary treatment) and two NESA XSIGNAL® devices operating in double-blind (due to the imperceptivity of the stimulation performed, there will be a placebo machine and another that applies the treatment).
At the end of the study, the results obtained between the different groups of patients will be able to be compared; those additionally treated with a device, those treated with a placebo device and those in the standard rehabilitation procedure without a device.
The variables of the study will be collected at three time points: before the intervention, during the intervention and at the end of the intervention.
The statistical analysis will be an intention-to-treat analysis. For the main outcomes variables a two factor ANOVA will-be performed (intervention-time) with a post-hoc analysis with kruskal wallis correction correction. Statistical significance will be defined as p <0.05
- Conditions
- Basketball Player
- Being tested
- Non-invasive Neuromodulation, Placebo Non-invasive Neuromodulation
- Keywords
- physical therapy modality, Electric Stimulation Therapy, basketball
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive NeuromodulationDevice
The electrodes will be placed with the help of gloves and adapted socks for 1 hour, twice a week, until 10 intervention sessions are completed. In addition, depending on the session, an adhesive electrode will be placed at the level of C7. Characteristics of microcurrents:
pulsed monophasic rectangular wave with a pulse of 1.3 s and pause of 300 ms, voltage 3 mV and intensity 0.5 μA.
Placebo Non-invasive NeuromodulationDevice
The same protocol described for the experimental group will be applied, but microcurrents device which will be previously manipulated and tested with an oscilloscope so that they do not emit electrical currents.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive Neuromodulation | Experimental | Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level. Receives: Device: Non-invasive Neuromodulation |
| Placebo Non-invasive Neuromodulation | Placebo comparator | Placebo microcurrents Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level. Receives: Device: Placebo Non-invasive Neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in creatinine kinase level
For the analysis of these biomarkers, a saliva sample, collected with Salivette containers will be necessary. Once the sample is obtained, it will be kept following the necessary security protocols and sent to a laboratory for further analysis.
Measured: 48 hours before the first match, immediately after the match and 48 hours after the match
Secondary outcomes (7)
Kinematic demand parameters (external load) I
Total distance traveled (meters minute)
Measured: Through study completion, an average of 6 weeks
Kinematic demand parameters (external load) II
Player Load (vector magnitude expressed as the square root of the sum of the squared instantaneous rates of change in acceleration in each of the 3 planes divided by 100) in arbitrary units (>0.02 AU; m·min-1)
Measured: During the match and all the intervention ( 6 weeks)
Kinematic demand parameters (external load) III
High-speed running absolute (HSR distance covered above 18 km·h -1; m·min-1
Measured: During all the intervention ( 6 weeks)
Kinematic demand parameters (external load) IV
Relative high-speed running (RHSR, distance covered above 85% of individual maximum speed recorded in training sessions or matches; m·min-1)
Measured: Through study completion, an average of 6 weeks
Cardiovascular parameters: heart rate variability (VHR)
It is proposed to observe the changes or adaptations presented by the player once the sporting activity has ceased, by quantifying the modulation between the sympathetic and parasympathetic systems
Measured: Up to 6 weeks
Perceptual parameters
A Wellness questionnaire consisting of four questions on the level of fatigue, stress, sleep and muscle pain before the game. Each question is scored individually with scores ranging from 1 ("Very, very low or good") to 7 ("Very, very high or bad"). The higher the score, the worse the results. The largest value would be 49, while the smallest would be 4
Measured: Up to 6 weeks
Perceptual parameters II
Perception of Effort questionnaire to value perceived by the athlete will be recorded during the days of the intervention.also known as the Borg scale of perceived exertion measures the entire range of exertion that the individual perceives when exercising. The instrument consists of a table with numbers between 20 and 6, placed vertically and accompanied by qualitative evaluations between very, very strong and very, very light.
Measured: During all the intervention. Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start1 May 2021
- Primary completion30 Sep 2021
- Study completion18 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Basketball PlayerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Las Palmas de Gran Canaria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aníbal Báez Suárez, University of Las Palmas de Gran Canaria
- Investigators
- Aníbal Báez-Suárez, PhD, Principal investigator, University of Las Palmas de Gran Canaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939181
- Sponsor's protocol ID
- NESABarça
- Status last verified
- Dec 2021
- First submitted
- 8 Jun 2021
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Impellizzeri FM, Marcora SM, Coutts AJ. Internal and External Training Load: 15 Years On. Int J Sports Physiol Perform. 2019 Feb 1;14(2):270-273. doi: 10.1123/ijspp.2018-0935. Epub 2019 Jan 6.
PubMed 30614348Vanrenterghem J, Nedergaard NJ, Robinson MA, Drust B. Training Load Monitoring in Team Sports: A Novel Framework Separating Physiological and Biomechanical Load-Adaptation Pathways. Sports Med. 2017 Nov;47(11):2135-2142. doi: 10.1007/s40279-017-0714-2.
PubMed 28283992Kellmann M, Bertollo M, Bosquet L, Brink M, Coutts AJ, Duffield R, Erlacher D, Halson SL, Hecksteden A, Heidari J, Kallus KW, Meeusen R, Mujika I, Robazza C, Skorski S, Venter R, Beckmann J. Recovery and Performance in Sport: Consensus Statement. Int J Sports Physiol Perform. 2018 Feb 1;13(2):240-245. doi: 10.1123/ijspp.2017-0759. Epub 2018 Feb 19.
PubMed 29345524Bragazzi NL, Khoramipour K, Chaouachi A, Chamari K. Toward Sportomics: Shifting From Sport Genomics to Sport Postgenomics and Metabolomics Specialties. Promises, Challenges, and Future Perspectives. Int J Sports Physiol Perform. 2020 Sep 22;15(9):1201-1202. doi: 10.1123/ijspp.2020-0648. No abstract available.
PubMed 32963119Fernandez D, Varo F, Carmona G, Reche X. Quantification of external load of elite rink hockey players in official matches. J Sports Med Phys Fitness. 2020 Dec;60(12):1520-1525. doi: 10.23736/S0022-4707.20.11097-1. Epub 2020 Jun 30.
PubMed 32608935Torreno N, Munguia-Izquierdo D, Coutts A, de Villarreal ES, Asian-Clemente J, Suarez-Arrones L. Relationship Between External and Internal Loads of Professional Soccer Players During Full Matches in Official Games Using Global Positioning Systems and Heart-Rate Technology. Int J Sports Physiol Perform. 2016 Oct;11(7):940-946. doi: 10.1123/ijspp.2015-0252. Epub 2016 Aug 24.
PubMed 26816391Rabbani A, Clemente FM, Kargarfard M, Chamari K. Match Fatigue Time-Course Assessment Over Four Days: Usefulness of the Hooper Index and Heart Rate Variability in Professional Soccer Players. Front Physiol. 2019 Feb 19;10:109. doi: 10.3389/fphys.2019.00109. eCollection 2019.
PubMed 30837890Dong JG. The role of heart rate variability in sports physiology. Exp Ther Med. 2016 May;11(5):1531-1536. doi: 10.3892/etm.2016.3104. Epub 2016 Feb 23.
PubMed 27168768Rave G, Zouhal H, Boullosa D, Doyle-Baker PK, Saeidi A, Abderrahman AB, Fortrat JO. Heart Rate Variability is Correlated with Perceived Physical Fitness in Elite Soccer Players. J Hum Kinet. 2020 Mar 31;72:141-150. doi: 10.2478/hukin-2019-0103. eCollection 2020 Mar.
PubMed 32269655Castro-Sepulveda M, Cancino J, Fernandez-Verdejo R, Perez-Luco C, Jannas-Vela S, Ramirez-Campillo R, Del Coso J, Zbinden-Foncea H. Basal Serum Cortisol and Testosterone/Cortisol Ratio Are Related to Rate of Na+ Lost During Exercise in Elite Soccer Players. Int J Sport Nutr Exerc Metab. 2019 Nov 1;29(6):658-663. doi: 10.1123/ijsnem.2019-0129.
PubMed 31629352Garcia F, Fernandez D, Vazquez-Guerrero J, Font R, Moreno-Planas B, Alamo-Arce D, Medina-Ramirez R, Mallol-Soler M. Recovery of the physiological status in professional basketball players using NESA neuromodulation treatment during different types of microcycles in season: A preliminary randomized clinical trial. Front Physiol. 2022 Nov 22;13:1032020. doi: 10.3389/fphys.2022.1032020. eCollection 2022.
PubMed 36483295
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Non-invasive Neuromodulation NESA in Neuroefficiency in Basketball Players on the Field
- ClinicalTrials.gov ID
- NCT04939181
- Acronym / sponsor ID
- NESABarça
- Conditions
- Basketball Player
- Keywords
- physical therapy modality, Electric Stimulation Therapy, basketball
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Las Palmas de Gran CanariaUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 18 Nov 2021 (actual)
- First posted
- 25 Jun 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.
Competitive team sports calendars are becoming increasingly compressed, generating changes in the effort-recovery cycle. Given this new situation, it seems necessary to analyze how it affects the physiological and performance level of semi-professional players, as well as how to observe if the non-invasive neuromodulation technique NESA helps the neuroefficiency and concentration values of said players.
Detailed description
The design of this study is a randomised, triple blind clinical trial with placebo control.
The general configuration of the study consists of capturing the second basketball team of FC BARCELONA. For this, a double-blind capture system will be available (neither the specialist nor those responsible for recovery will know which patients are entering the complementary treatment) and two NESA XSIGNAL® devices operating in double-blind (due to the imperceptivity of the stimulation performed, there will be a placebo machine and another that applies the treatment).
At the end of the study, the results obtained between the different groups of patients will be able to be compared; those additionally treated with a device, those treated with a placebo device and those in the standard rehabilitation procedure without a device.
The variables of the study will be collected at three time points: before the intervention, during the intervention and at the end of the intervention.
The statistical analysis will be an intention-to-treat analysis. For the main outcomes variables a two factor ANOVA will-be performed (intervention-time) with a post-hoc analysis with kruskal wallis correction correction. Statistical significance will be defined as p <0.05
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-invasive Neuromodulation | Experimental | Device: Non-invasive NeuromodulationIntervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level. |
| Placebo Non-invasive Neuromodulation | Placebo comparator | Device: Placebo Non-invasive NeuromodulationPlacebo microcurrents Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Belonging to the team
- Participants do not present injury or pathology during the study
- In normal conditions and mentally competent to participate in the study.
- In condition to complete the study questionnaires.
Key exclusion criteria (3 listed)
- Present some of the contraindications for a treatment with non-invasive neuromodulation: pacemakers, internal bleeding, do not apply electrodes on skin in poor condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and / or electricity phobia.
- Not having signed the informed consent.
- Present any injury or pathology during the study
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 |
|---|---|---|
| Non-invasive NeuromodulationThe electrodes will be placed with the help of gloves and adapted socks for 1 hour, twice a week, until 10 intervention sessions are completed. In addition, depending on the session, an adhesive electrode will be placed at the level of C7. Characteristics of microcurrents: pulsed monophasic rectangular wave with a pulse of 1.3 s and pause of 300 ms, voltage 3 mV and intensity 0.5 μA. | Device | Non-invasive Neuromodulation |
| Placebo Non-invasive NeuromodulationThe same protocol described for the experimental group will be applied, but microcurrents device which will be previously manipulated and tested with an oscilloscope so that they do not emit electrical currents. | Device | Placebo Non-invasive Neuromodulation |
Primary outcome
Changes in creatinine kinase level
Time frame: 48 hours before the first match, immediately after the match and 48 hours after the match
For the analysis of these biomarkers, a saliva sample, collected with Salivette containers will be necessary. Once the sample is obtained, it will be kept following the necessary security protocols and sent to a laboratory for further analysis.
7 secondary outcomes
Kinematic demand parameters (external load) I
Time frame: Through study completion, an average of 6 weeks
Kinematic demand parameters (external load) II
Time frame: During the match and all the intervention ( 6 weeks)
Kinematic demand parameters (external load) III
Time frame: During all the intervention ( 6 weeks)
Kinematic demand parameters (external load) IV
Time frame: Through study completion, an average of 6 weeks
Cardiovascular parameters: heart rate variability (VHR)
Time frame: Up to 6 weeks
Perceptual parameters
Time frame: Up to 6 weeks
Perceptual parameters II
Time frame: During all the intervention. Up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Results publication: PubMed 30614348Impellizzeri FM, Marcora SM, Coutts AJ. Internal and External Training Load: 15 Years On. Int J Sports Physiol Perform. 2019 Feb 1;14(2):270-273. doi: 10.1123/ijspp.2018-0935. Epub 2019 Jan 6.
- Results publication: PubMed 28283992Vanrenterghem J, Nedergaard NJ, Robinson MA, Drust B. Training Load Monitoring in Team Sports: A Novel Framework Separating Physiological and Biomechanical Load-Adaptation Pathways. Sports Med. 2017 Nov;47(11):2135-2142. doi: 10.1007/s40279-017-0714-2.
- Results publication: PubMed 29345524Kellmann M, Bertollo M, Bosquet L, Brink M, Coutts AJ, Duffield R, Erlacher D, Halson SL, Hecksteden A, Heidari J, Kallus KW, Meeusen R, Mujika I, Robazza C, Skorski S, Venter R, Beckmann J. Recovery and Performance in Sport: Consensus Statement. Int J Sports Physiol Perform. 2018 Feb 1;13(2):240-245. doi: 10.1123/ijspp.2017-0759. Epub 2018 Feb 19.
- Results publication: PubMed 32963119Bragazzi NL, Khoramipour K, Chaouachi A, Chamari K. Toward Sportomics: Shifting From Sport Genomics to Sport Postgenomics and Metabolomics Specialties. Promises, Challenges, and Future Perspectives. Int J Sports Physiol Perform. 2020 Sep 22;15(9):1201-1202. doi: 10.1123/ijspp.2020-0648. No abstract available.
- Results publication: PubMed 32608935Fernandez D, Varo F, Carmona G, Reche X. Quantification of external load of elite rink hockey players in official matches. J Sports Med Phys Fitness. 2020 Dec;60(12):1520-1525. doi: 10.23736/S0022-4707.20.11097-1. Epub 2020 Jun 30.
- Results publication: PubMed 26816391Torreno N, Munguia-Izquierdo D, Coutts A, de Villarreal ES, Asian-Clemente J, Suarez-Arrones L. Relationship Between External and Internal Loads of Professional Soccer Players During Full Matches in Official Games Using Global Positioning Systems and Heart-Rate Technology. Int J Sports Physiol Perform. 2016 Oct;11(7):940-946. doi: 10.1123/ijspp.2015-0252. Epub 2016 Aug 24.
- Results publication: PubMed 30837890Rabbani A, Clemente FM, Kargarfard M, Chamari K. Match Fatigue Time-Course Assessment Over Four Days: Usefulness of the Hooper Index and Heart Rate Variability in Professional Soccer Players. Front Physiol. 2019 Feb 19;10:109. doi: 10.3389/fphys.2019.00109. eCollection 2019.
- Results publication: PubMed 27168768Dong JG. The role of heart rate variability in sports physiology. Exp Ther Med. 2016 May;11(5):1531-1536. doi: 10.3892/etm.2016.3104. Epub 2016 Feb 23.
- Results publication: PubMed 32269655Rave G, Zouhal H, Boullosa D, Doyle-Baker PK, Saeidi A, Abderrahman AB, Fortrat JO. Heart Rate Variability is Correlated with Perceived Physical Fitness in Elite Soccer Players. J Hum Kinet. 2020 Mar 31;72:141-150. doi: 10.2478/hukin-2019-0103. eCollection 2020 Mar.
- Results publication: PubMed 31629352Castro-Sepulveda M, Cancino J, Fernandez-Verdejo R, Perez-Luco C, Jannas-Vela S, Ramirez-Campillo R, Del Coso J, Zbinden-Foncea H. Basal Serum Cortisol and Testosterone/Cortisol Ratio Are Related to Rate of Na+ Lost During Exercise in Elite Soccer Players. Int J Sport Nutr Exerc Metab. 2019 Nov 1;29(6):658-663. doi: 10.1123/ijsnem.2019-0129.
- Derived from this study: PubMed 36483295Garcia F, Fernandez D, Vazquez-Guerrero J, Font R, Moreno-Planas B, Alamo-Arce D, Medina-Ramirez R, Mallol-Soler M. Recovery of the physiological status in professional basketball players using NESA neuromodulation treatment during different types of microcycles in season: A preliminary randomized clinical trial. Front Physiol. 2022 Nov 22;13:1032020. doi: 10.3389/fphys.2022.1032020. eCollection 2022.
- Individual participant dataSharing planned: No
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.
Aníbal Báez-Suárez, PhD principal investigator
University of Las Palmas de Gran Canaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive Neuromodulation in people with Basketball Player, run by University of Las Palmas de Gran Canaria 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 4 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: finished, as of the sponsor's last update on 14 Dec 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in creatinine kinase level (time frame: 48 hours before the first match, immediately after the match and 48 hours after the match). 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 NCT04939181, which also lists 11 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 14 Dec 2021.