Ignite Creation Date:
2024-05-06 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05289817
Status:
COMPLETED
Last Update Posted:
2022-11-01
First Post:
2022-02-10
Brief Title:
Effects of Transcutaneous Electrical Stimulation on the Autonomous Nerve System in Healthy Young People
Sponsor:
Universidade da Coruña
Organization:
Universidade da Coruña
Study Overview
Official Title:
Effectiveness of Transcutaneous Electrical Stimulation on the Autonomous and Cardiovascular System on Healthy Young People a Prospective Randomized Single-blind Controlled Pilot Study
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESautonomous
Brief Summary:
Cardiovascular disease is one of the most important causes of death and disability in the world An autonomic imbalance is associated to cardiovascular risks and disorders Electrical stimulation ES applied by surface electrodes is a non-invasive therapeutic approach with low side-effects In the last years some studies had investigated the effects of ES on the autonomic nervous system and cardiovascular system However different intensities frequencies and electrode locations had been used which makes difficult to clarify the optimal parameters
The aim of this study is to analyze the effects of ES on autonomic nervous modulation in healthy subjects comparing three different locations of application for ES
Participants will be aleatory assigned to one of three groups for a single-session of 20-minute transcutaneous ES a an auricular intermittent ES in an area that is believed to be connected to the vagal nerve cymba conchae b an auricular sham intermittent ES meaning a real ES but applied on an ear location not connected to the vagal nerve scapha and c an upper back continuous ES C7-T4 a placement that is thought to be connected to the stellate sympathetic ganglion All the protocols will be stated at a non-painful intensity After that the hand grip exercise will be executed
The heart rate variability HRV and heart frequency HR will be measured in four main times the baseline in the final minutes of the ES after the ES and after finishing the hand grip exercise Blood pressure will be measured also at all the time points except during the ES due to the possibility of interferences Adverse effects will be assessed after ES and 48 h later The study will provide initial knowledge about how different electrical stimulation locations contribute to reduce sympathetic excitation and improve the sympathovagal balance
The aim of this study is to analyze the effects of ES on autonomic nervous modulation in healthy subjects comparing three different locations of application for ES
Participants will be aleatory assigned to one of three groups for a single-session of 20-minute transcutaneous ES a an auricular intermittent ES in an area that is believed to be connected to the vagal nerve cymba conchae b an auricular sham intermittent ES meaning a real ES but applied on an ear location not connected to the vagal nerve scapha and c an upper back continuous ES C7-T4 a placement that is thought to be connected to the stellate sympathetic ganglion All the protocols will be stated at a non-painful intensity After that the hand grip exercise will be executed
The heart rate variability HRV and heart frequency HR will be measured in four main times the baseline in the final minutes of the ES after the ES and after finishing the hand grip exercise Blood pressure will be measured also at all the time points except during the ES due to the possibility of interferences Adverse effects will be assessed after ES and 48 h later The study will provide initial knowledge about how different electrical stimulation locations contribute to reduce sympathetic excitation and improve the sympathovagal balance
Detailed Description:
Electrical stimulation ES of the nervous system also denominated as neuromodulation has been investigated for diverse conditions as cardiovascular diseases chronic pain and psychiatric conditions It is unknown which locations and parameters can be more effective and better tolerated The transcutaneous ES is a non-invasive technique which has fewer side-effects than subcutaneous vagus nerve stimulation
The aim of this study is to analyze the acute effects of transcutaneous ES on autonomic nervous modulation by heart rate variability HRV heart frequency HF and blood pressure BP in healthy subjects comparing three different locations for the ES before and after a hand-grip exercise In addition the tolerance to the current the side-effects and the perceived exertion will be compared
Once the participants have given their informed consent and had been checked for exclusion criteria are invited to an experimental session Subjects will be advised to refrain from caffeine or alcohol for 12 h and vigorous exercise for at least 24h prior to the intervention
The participants will remain sitting during the entire session and will be instructed to stay awake and avoid movement Grip strength will be evaluated by a hydraulic dynamometer Saehan model SH5001 Participants will remain seated on a chair with their feet and trunk supported shoulders adducted elbows flexed at 90º forearms in neutral position and wrists with 0º-30º extension Subjects will be instructed to perform a maximum isometric contraction for three to five seconds and the peak force will be recorded Three evaluations will be made with an interval of one minute between them If the examiner would recognize some compensatory movement by the participant a new measurement would be taken and registered
The volunteers will be randomized by sex to one of three groups cymba conchae at the right ear active group C7-T4 placement active group scapha at the right ear sham-group These three arms will be denominated as Transcutaneous Vagus Electrical Nerve Stimulation t-VNS Transcutaneous Sympathetic Ganglion Electrical Nerve Stimulation t-SNS and Sham Transcutaneous Vagus Electrical Nerve Stimulation sham t-VNS and Allocation concealment stratified by sex will be ensured by the use of sealed envelopes containing the treatment allocation The sequence will be generated using a computer program by a researcher not implicated in the experimental sessions The envelopes will be opened just before determining the amplitude for stimulation The stimulation location will be wiped down with alcohol and the minimum intensity at which the stimulus is perceived will be evaluated for the auricular locations whereas minimum amplitude for muscle contraction between the electrodes will be assessed in cervico-thoracic location
After 15 minutes of resting the first assessment baseline will be taken HRV HR and blood pressure for 5 minutes The respiratory frequency will be checked every 5 minutes
Then the randomized ES will be applied for 20 minutes using the same TENSMED S82 Enraf Nonius The Netherlands symmetrical and rectangular biphasic pulses at 350 microseconds of phase duration It will be applied at 10 Hz t-VNS and sham t-VNS or 5 Hz t-SNS Both the two protocols applied to the auricular region t-VNS and sham t-VNS will be delivered by trains whereas a continuous ES will be selected for the t-SNS The minimum amplitude for auricular stimulations t-VNS and sham t-VNS will be twice the perception threshold at a comfortable intensity under the discomfort threshold pain onset It will be increased during the stimulation only if the sensation is clearly decreased to a maximum of 9 mA The perception threshold will be set increasing amplitude by 05 mA each 3 seconds from 0 mA Amplitude in t-SNS will be set at a muscle contraction at a comfortable intensity under discomfort threshold or pain onset The motor threshold will be determined by increasing amplitude 05 mA each 3 seconds from the perception threshold until a motor contraction is observed The initial amplitude will be 2 mA over this threshold It will be increased during the stimulation only if the stimulus falls down to a maximum of 25 mA
Another 5-minute period after ES will be recorded and then the 3-minute hand grip exercise SH5001 Saehan Korea at 30 of maximum strength will be required
The final assessment of cardiovascular and autonomous variables will be obtained during the last 15 minutes The rating of perceived exertion will be asked Borg-CR10 whereas a VAS 0 denoting no sensation at all 10 indicating discomfort or pain onset will be used to rate the tolerance to ES The possible side-effects will be also checked
The participants will be asked upon completion of the session their presumed group assignment
Adverse effects will be checked again 48 h after finishing the experimental session
The ES and the acquisition of the data will be done by physical therapists but analysis of the main variables will be done by a cardiologist with the assistance of one of the physical therapists with specific knowledge in the area The data will be introduced by a third researcher and accuracy of the data will be checked selecting 50 of the data from each arm by random software If some mistakes will emerge then the complete check will be done The traditional statistical analysis will be reinforced by Bayesian inferences
This is a pilot study The objective is to check if there are statistically significant effects from the stimulation on the variables cardiac variability heart rate and blood pressure before or after an isometric exercise of pressure
For the comparison of the results obtained in the three groups of subjects the analysis of variance or rank test procedures will be used based on the normality or non-normality of the data obtained
The effect of time will be assessed through a longitudinal data analysis that takes into account the dependence For this purpose the repeated measures Anova or Friedmans test will be used in the parametric or non-parametric assumption as a global comparison procedure Possible interactions and dependence relationships between measured variables and time will be studied by means of linear regression analysis generalised linear andor generalised kernel-type non-parametric modelling
Comparisons between groups Anova or its non-parametric equivalent will be complemented by means of their equivalents in Bayesian analysis in order to reinforce the information provided by the p-values obtained in each procedure For this purpose the corresponding Bayes factors Kass and Raftery 1995 and the posteriori distributions of the estimated parameters will be calculated thus increasing the precision of the confidence intervals
The aim of this study is to analyze the acute effects of transcutaneous ES on autonomic nervous modulation by heart rate variability HRV heart frequency HF and blood pressure BP in healthy subjects comparing three different locations for the ES before and after a hand-grip exercise In addition the tolerance to the current the side-effects and the perceived exertion will be compared
Once the participants have given their informed consent and had been checked for exclusion criteria are invited to an experimental session Subjects will be advised to refrain from caffeine or alcohol for 12 h and vigorous exercise for at least 24h prior to the intervention
The participants will remain sitting during the entire session and will be instructed to stay awake and avoid movement Grip strength will be evaluated by a hydraulic dynamometer Saehan model SH5001 Participants will remain seated on a chair with their feet and trunk supported shoulders adducted elbows flexed at 90º forearms in neutral position and wrists with 0º-30º extension Subjects will be instructed to perform a maximum isometric contraction for three to five seconds and the peak force will be recorded Three evaluations will be made with an interval of one minute between them If the examiner would recognize some compensatory movement by the participant a new measurement would be taken and registered
The volunteers will be randomized by sex to one of three groups cymba conchae at the right ear active group C7-T4 placement active group scapha at the right ear sham-group These three arms will be denominated as Transcutaneous Vagus Electrical Nerve Stimulation t-VNS Transcutaneous Sympathetic Ganglion Electrical Nerve Stimulation t-SNS and Sham Transcutaneous Vagus Electrical Nerve Stimulation sham t-VNS and Allocation concealment stratified by sex will be ensured by the use of sealed envelopes containing the treatment allocation The sequence will be generated using a computer program by a researcher not implicated in the experimental sessions The envelopes will be opened just before determining the amplitude for stimulation The stimulation location will be wiped down with alcohol and the minimum intensity at which the stimulus is perceived will be evaluated for the auricular locations whereas minimum amplitude for muscle contraction between the electrodes will be assessed in cervico-thoracic location
After 15 minutes of resting the first assessment baseline will be taken HRV HR and blood pressure for 5 minutes The respiratory frequency will be checked every 5 minutes
Then the randomized ES will be applied for 20 minutes using the same TENSMED S82 Enraf Nonius The Netherlands symmetrical and rectangular biphasic pulses at 350 microseconds of phase duration It will be applied at 10 Hz t-VNS and sham t-VNS or 5 Hz t-SNS Both the two protocols applied to the auricular region t-VNS and sham t-VNS will be delivered by trains whereas a continuous ES will be selected for the t-SNS The minimum amplitude for auricular stimulations t-VNS and sham t-VNS will be twice the perception threshold at a comfortable intensity under the discomfort threshold pain onset It will be increased during the stimulation only if the sensation is clearly decreased to a maximum of 9 mA The perception threshold will be set increasing amplitude by 05 mA each 3 seconds from 0 mA Amplitude in t-SNS will be set at a muscle contraction at a comfortable intensity under discomfort threshold or pain onset The motor threshold will be determined by increasing amplitude 05 mA each 3 seconds from the perception threshold until a motor contraction is observed The initial amplitude will be 2 mA over this threshold It will be increased during the stimulation only if the stimulus falls down to a maximum of 25 mA
Another 5-minute period after ES will be recorded and then the 3-minute hand grip exercise SH5001 Saehan Korea at 30 of maximum strength will be required
The final assessment of cardiovascular and autonomous variables will be obtained during the last 15 minutes The rating of perceived exertion will be asked Borg-CR10 whereas a VAS 0 denoting no sensation at all 10 indicating discomfort or pain onset will be used to rate the tolerance to ES The possible side-effects will be also checked
The participants will be asked upon completion of the session their presumed group assignment
Adverse effects will be checked again 48 h after finishing the experimental session
The ES and the acquisition of the data will be done by physical therapists but analysis of the main variables will be done by a cardiologist with the assistance of one of the physical therapists with specific knowledge in the area The data will be introduced by a third researcher and accuracy of the data will be checked selecting 50 of the data from each arm by random software If some mistakes will emerge then the complete check will be done The traditional statistical analysis will be reinforced by Bayesian inferences
This is a pilot study The objective is to check if there are statistically significant effects from the stimulation on the variables cardiac variability heart rate and blood pressure before or after an isometric exercise of pressure
For the comparison of the results obtained in the three groups of subjects the analysis of variance or rank test procedures will be used based on the normality or non-normality of the data obtained
The effect of time will be assessed through a longitudinal data analysis that takes into account the dependence For this purpose the repeated measures Anova or Friedmans test will be used in the parametric or non-parametric assumption as a global comparison procedure Possible interactions and dependence relationships between measured variables and time will be studied by means of linear regression analysis generalised linear andor generalised kernel-type non-parametric modelling
Comparisons between groups Anova or its non-parametric equivalent will be complemented by means of their equivalents in Bayesian analysis in order to reinforce the information provided by the p-values obtained in each procedure For this purpose the corresponding Bayes factors Kass and Raftery 1995 and the posteriori distributions of the estimated parameters will be calculated thus increasing the precision of the confidence intervals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None