Neuromodulation of the Autonomic Nervous System in Athletes

Efficacy, Self Clinical Trial

— NANSA  

Official title:

Neuromodulation of the Autonomic Nervous System in Athletes (NANSA Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06281795
• Other study ID #: 1.24.
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: January 31, 2026

Study information

• Verified date: February 2024
• Source: Bakulev Scientific Center of Cardiovascular Surgery
• Contact: Vladimir Shvartz
• Phone: +79032619292
• Email: vashvarts[@]bakulev.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There are few studies in the literature that have evaluated the effects of using percutaneous stimulation of the auricular branch of the vagus nerve for sports purposes (to accelerate recovery after physical exertion). It has been demonstrated that tVNS in athletes improved the rate of heart rate recovery, reduced lactic acid levels in blood plasma, reduced pain, reduced overtraining syndrome and fatigue levels.

Description:

Several studies have shown that transcutaneous vagus nerve stimulation (tVNS) potentially exhibits therapeutic effects similar to its invasive counterpart. tVNS is performed using surface electrodes and low-frequency electrical currents, targeting specific locations, most commonly the auricular branch of the vagus nerve or its cervical branch. Stimulation of the auricular branch of the vagus nerve activates vagal sensory fibers, simulating sensory input to the brainstem and forming what is known as the auriculo-vagal afferent pathway. Since these fibers project directly to the nucleus of the solitary tract (also known as the solitary tract nucleus), which in turn has direct or indirect projections to nuclei that provide noradrenergic, endorphinergic, and serotonergic fibers in various parts of the brain, regulating systemic parameters of cardiovascular, respiratory, and immune functions, it can be expected that the body's response to stimulation of the auricular branch of the vagus nerve will be systemic. With the onset of physical exercise, sympathetic activity in the body increases and reaches a plateau value after a certain period of maximum activity. After the end of physical exercise, suppressed parasympathetic activity begins to intensify, and the sympathetic system gradually returns to a resting state. After training, parasympathetic system activation continues for up to 48 hours. In certain types of training, when the frequency of anaerobic respiration increases during physical exertion, a decrease in parasympathetic reactivation may be observed. In the literature, there are individual studies that have evaluated the effects of transcutaneous stimulation of the auricular branch of the vagus nerve for sports purposes (to accelerate recovery processes after physical exertion). It has been demonstrated that tVNS in athletes improves heart rate recovery, reduces lactate levels in plasma, reduces pain sensations, decreases overtraining syndrome, and reduces fatigue levels. The aim of this study is to: evaluate the influence of low-frequency electrical stimulation of the auricular branch of the vagus nerve on the functional reserve of the cardiovascular and respiratory systems in athletes during the post-training period, after high-intensity workouts.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 35 Years

Eligibility

Inclusion Criteria:

• Professional athletes over the age of 15 and under the age of 35;
• Cyclic sports (swimming, modern pentathlon, athletics, triathlon);
• Difficult coordination sports (dance sports, rhythmic gymnastics);
• Sports category: no lower than candidate for master of sports;
• Voluntary informed consent.

Exclusion Criteria:

• Atypical and unrelated to physical exertion changes on the ECG (T wave inversion, st-segment depression, pathological Q waves, signs of left atrial enlargement, signs of right ventricular hypertrophy, ventricular pre-excitation, complete right or left bundle branch block, prolonged or shortened Q-T interval, Brugada-like early repolarization);
• Heart rhythm and conduction disorders (frequent ventricular and supraventricular extrasystoles, first-degree atrioventricular block (P-Q > 0.21 s, not shortened during hyperventilation or physical exertion), second or third degree);
• Expressed sinus bradycardia with resting heart rate < 40 bpm;
• Taking glucocorticosteroids in the last 1 month;
• Taking any antiarrhythmic drugs, including beta-blockers.

Related Conditions & MeSH terms

• Efficacy, Self
• Fatigue
• Fatigue, Mental
• Fatigue; Muscle, Heart
• Mental Fatigue

Intervention

Device:
• tVNS
tVNS will be performed daily after workouts for 60 minutes over a period of 8 weeks.

Locations

Country	Name	City	State
Russian Federation	Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION	Krasnodar

Sponsors (3)

Lead Sponsor	Collaborator
Bakulev Scientific Center of Cardiovascular Surgery	Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION, Foundation for the Support of Physical Culture and Sports BECOME A CHAMPION

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamics of maximum oxygen consumption (VO2max).	During a cardiorespiratory exercise test, the level of VO2max (ml/min/kg) is assessed.	The level of VO2max is estimated at the beginning of the study (initially) and at the end of the study (after 8 weeks) in the active and fictitious stimulation groups.
Primary	The dynamics of the treadmill speed at the level of the anaerobic threshold of metabolism.	During the cardiorespiratory exercise test, the treadmill speed (km/h) is estimated at the level of the anaerobic metabolic threshold.	Treadmill speed is estimated at the beginning of the study (initially) and at the end of the study (after 8 weeks) in the active and dummy stimulation groups.
Secondary	Dynamics of the treadmill speed at the level of the aerobic metabolism threshold of metabolism.	During the cardiorespiratory exercise test, the treadmill speed (km/h) is estimated at the level of the aerobic metabolic threshold.	Treadmill speed is estimated at the beginning of the study (initially) and at the end of the study (after 8 weeks) in the active and dummy stimulation groups.
Secondary	The dynamics of the heart rate (HR) at the level of the anaerobic threshold of metabolism.	During the cardiorespiratory exercise test, the HR is estimated at the level of the anaerobic metabolic threshold.	HR is estimated at the beginning of the study (initially) and at the end of the study (after 8 weeks) in the active and dummy stimulation groups.
Secondary	The dynamics of the heart rate (HR) at the level of the aerobic threshold of metabolism.	During the cardiorespiratory exercise test, the HR is estimated at the level of the aerobic metabolic threshold.	HR is estimated at the beginning of the study (initially) and at the end of the study (after 8 weeks) in the active and dummy stimulation groups.
Secondary	The dynamics of RMSSD.	During the time analysis of heart rate variability, the RMSSD parameter is estimated.	This parameter is evaluated at the beginning of the study (initially) and at the end of the study (after 8 weeks) in the groups of active and fictitious stimulation.
Secondary	HF dynamics	During the spectral analysis of heart rate variability, the HF (high frequency) parameter is estimated.	This parameter is evaluated at the beginning of the study (initially) and at the end of the study (after 8 weeks) in the groups of active and fictitious stimulation.
Secondary	Dynamics of the LF/HF ratio.	The LF/HF ratio is estimated during the spectral analysis of heart rate variability.	This LF/HF ratio is evaluated at the beginning of the study (initially) and at the end of the study (after 8 weeks) in the active and fictitious stimulation groups.

External Links

•   The effect of transcutaneous auricular vagus nerve stimulation on cycling ergometry and recovery in healthy young individuals