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Completed

NCT Number: NCT04939181

Non-invasive Neuromodulation NESA in Neuroefficiency in Basketball Players

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.

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Key information

Conditions

Basketball Player

Age range

18 year–24 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Aníbal Báez-Suárez

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive Neuromodulation

Device

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 Neuromodulation

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Kinematic demand parameters (external load) I

    Time frame: Through study completion, an average of 6 weeks

    Total distance traveled (meters minute)

  2. Kinematic demand parameters (external load) II

    Time frame: During 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)

  3. Kinematic demand parameters (external load) III

    Time frame: During all the intervention ( 6 weeks)

    High-speed running absolute (HSR distance covered above 18 km·h -1; m·min-1

  4. Kinematic demand parameters (external load) IV

    Time frame: Through study completion, an average of 6 weeks

    Relative high-speed running (RHSR, distance covered above 85% of individual maximum speed recorded in training sessions or matches; m·min-1)

  5. Cardiovascular parameters: heart rate variability (VHR)

    Time frame: Up to 6 weeks

    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

  6. Perceptual parameters

    Time frame: Up to 6 weeks

    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

  7. Perceptual parameters II

    Time frame: During all the intervention. Up to 6 weeks

    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.

Other outcomes

  1. Basketball free throw efficiency

    Time frame: Up to 6 weeks

    Variable 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.

Sponsors and collaborators

Lead sponsor

University of Las Palmas de Gran Canaria

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 25, 2021
Registry last updated
Dec 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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