Clinical trial NCT04939181: Non-invasive Neuromodulation NESA in Neuroefficiency in Basketball Players
Official title: Efficacy of Non-invasive Neuromodulation NESA in Neuroefficiency in Basketball Players on the Field
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Basketball Player
Keywords: physical therapy modality
Electric Stimulation Therapy
basketball
Lead sponsor: University of Las Palmas de Gran Canaria
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Changes in creatinine kinase level
timeFrame: 48 hours before the first match, immediately after the match and 48 hours after the match
Secondary outcomes:
measure: Kinematic demand parameters (external load) I
timeFrame: Through study completion, an average of 6 weeks
measure: Kinematic demand parameters (external load) II
timeFrame: During the match and all the intervention ( 6 weeks)
measure: Kinematic demand parameters (external load) III
timeFrame: During all the intervention ( 6 weeks)
measure: Kinematic demand parameters (external load) IV
timeFrame: Through study completion, an average of 6 weeks
measure: Cardiovascular parameters: heart rate variability (VHR)
timeFrame: Up to 6 weeks
measure: Perceptual parameters
timeFrame: Up to 6 weeks
measure: Perceptual parameters II
timeFrame: During all the intervention. Up to 6 weeks
Other outcomes:
measure: Basketball free throw efficiency
timeFrame: Up to 6 weeks
Locations:
city: Las Palmas de Gran Canaria
country: Spain
facility: Aníbal Báez-Suárez
state: Las Palmas
Study officials:
affiliation: University of Las Palmas de Gran Canaria
name: Aníbal Báez-Suárez, PhD
role: PRINCIPAL_INVESTIGATOR
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