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Non-invasive Neuromodulation NESA in Neuroefficiency in Basketball Players

Efficacy of Non-invasive Neuromodulation NESA in Neuroefficiency in Basketball Players on the Field

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04939181
Enrollment
12
Registered
2021-06-25
Start date
2021-05-01
Completion date
2021-11-18
Last updated
2021-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basketball Player

Keywords

physical therapy modality, Electric Stimulation Therapy, basketball

Brief 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 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

Interventions

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.

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.

Sponsors

University of Las Palmas de Gran Canaria
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 24 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Changes in creatinine kinase level48 hours before the first match, immediately after the match and 48 hours after the matchFor 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.

Secondary

MeasureTime frameDescription
Kinematic demand parameters (external load) IThrough study completion, an average of 6 weeksTotal distance traveled (meters minute)
Kinematic demand parameters (external load) IIDuring the match and all the intervention ( 6 weeks)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)
Kinematic demand parameters (external load) IIIDuring all the intervention ( 6 weeks)High-speed running absolute (HSR distance covered above 18 km·h -1; m·min-1
Cardiovascular parameters: heart rate variability (VHR)Up to 6 weeksIt 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
Perceptual parametersUp to 6 weeksA 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
Perceptual parameters IIDuring all the intervention. Up to 6 weeksPerception 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.
Kinematic demand parameters (external load) IVThrough study completion, an average of 6 weeksRelative high-speed running (RHSR, distance covered above 85% of individual maximum speed recorded in training sessions or matches; m·min-1)

Other

MeasureTime frameDescription
Basketball free throw efficiencyUp to 6 weeksVariable analyzed by counting the number of free throws taken and the number of shots that enter the ring. To measure this type of throw during training, a protocolized Task will be carried out where each player shoots between 4 and 6 free throws (in series of 2) each training in a pressure context.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026