Non-invasive Neuromodulation NESA in Neuroefficiency in Basketball Players

December 10, 2021 updated by: Aníbal Báez Suárez, University of Las Palmas de Gran Canaria

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
        • Aníbal Báez-Suárez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

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 Comparator: Placebo Non-invasive Neuromodulation
Placebo microcurrents Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level.
Device: Placebo Non-invasive Neuromodulation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: Through study completion, an average of 6 weeks
Total distance traveled (meters minute)
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)
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
Time Frame: During all the intervention ( 6 weeks)
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
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)
Through study completion, an average of 6 weeks
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
Up to 6 weeks
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
Up to 6 weeks
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.
During all the intervention. Up to 6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Las Palmas de Gran Canaria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

November 18, 2021

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

June 19, 2021

First Posted (Actual)

June 25, 2021

Study Record Updates

Last Update Posted (Actual)

December 14, 2021

Last Update Submitted That Met QC Criteria

December 10, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NESABarça

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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