Non-invasive Neuromodulation NESA in Neuroefficiency in Basketball Players

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Basketball Player

Intervention / Treatment
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* Device: Non-invasive Neuromodulation
* Device: Placebo Non-invasive Neuromodulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-invasive Neuromodulation<br>Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level. | Device: Non-invasive Neuromodulation<br>* 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.<br>|
| Placebo Comparator: Placebo Non-invasive Neuromodulation<br>Placebo microcurrents Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level. | Device: Placebo Non-invasive Neuromodulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 48 hours before the first match, immediately after the match and 48 hours after the match | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinematic demand parameters (external load) I | Total distance traveled (meters minute) | 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) | 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 | 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) | 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 | 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 | 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. | During all the intervention. Up to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical therapy modality, Electric Stimulation Therapy, basketball