Modulation of H-reflex After Application of Electric Currents in Healthy People

Study Overview
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Brief Summary
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The purpose of this study is to determinate whether the application of electric currents produce changes in the excitability of alpha moto neurone. Moreover evidence whether the effect of the electric currents can change the tone of the muscle under stimulation in healthy volunteers

Detailed Description
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In the last years several experimental studies have evidenced that the transcutaneous electric nerve stimulation (TENS) in peripheric application can cause a decrease of spasticity and modulation of H-reflexes. But if the application is in the central nervous system the results are different. So the purpose of this study is quantify the modulation of the excitability of alpha moto neurone when the application of the current is in the central nervous system compared with a sham group.

Official Title
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Modulation of H-reflex After Application of Electric Currents in Healthy People. Effects on Myotonometer Properties.A Pilot Study

Conditions
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Spasticity

Intervention / Treatment
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* Device: Transcutaneous Electrical Stimulation
* Device: 10Kilohertz (KHz)
* Device: Sham stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants will be volunteer healthy students of Physiotherapy, University of Castilla - La Mancha, older than 18 years. Exclusion Criteria: Neuromuscular disease Epilepsy Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area Osteosynthesis material in the upper limb Diabetes Cancer Cardiovascular disease Pacemaker or other implanted electrical device Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days. Presence of tattoos or other external agent introduced into the treatment or assessment area. Pregnancy Sensitivity disturbance in lower limb

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10 Kilohertz (KHz)<br>Transcutaneous application of 10 Kilohertz (KHz) current over the back for a 40 minutes session. The intensity of the current will increase until participants report a strong but comfortable sensation, just below motor threshold. | Device: Transcutaneous Electrical Stimulation<br>* TENS transcutaneous electrical stimulation over the back the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)<br>* Other names: TENS;Device: 10Kilohertz (KHz)<br>* 10 KHz transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)<br>|
| Experimental: Transcutaneous Electrical Stimulation<br>Transcutaneous application of TENS current over the back for a 40 minutes session. The intensity of the current will increase until participants report a strong but comfortable sensation, just below motor threshold. Currents parameters are frequency 100 Hz and pulse width 100 microseconds | Device: Transcutaneous Electrical Stimulation<br>* TENS transcutaneous electrical stimulation over the back the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)<br>* Other names: TENS;|
| Sham Comparator: Sham stimulation<br>Electrodes are placed over the back for a 40 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel. | Device: Sham stimulation<br>* Sham transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline H reflex | H-reflex data are obtained by EMG signal. The EMG electrode (SignalConditioningElectrodes v2.3, Delsys Inc., USA) is fixed on triceps surae by the SENIAM protocol (www.seniam.org). The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa. | baseline at 0 min. | 
| During treatment H reflex | H-reflex data are obtained by EMG signal. The EMG electrode (SignalConditioningElectrodes v2.3, Delsys Inc., USA) is fixed on triceps surae by the SENIAM protocol (www.seniam.org). The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa. | During treatment at 33min. | 
| Post treatment H reflex | H-reflex data are obtained by EMG signal. The EMG electrode (SignalConditioningElectrodes v2.3, Delsys Inc., USA) is fixed on triceps surae by the SENIAM protocol (www.seniam.org). The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa. | Immediately after treatment at 40 min. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline muscle tone | This outcome measure is obtained by a device named MyotonPro. It is a commercial device made to calculate myotonometrics properties of the muscle. It is a non-invasive method to calculate the muscle tone. The investigators obtained many parameters like muscle stiffness, frequency and decrement. | Baseline at 0 min. | 
| Muscle tone during treatment | This outcome measure is obtained by a device named MyotonPro. It is a commercial device made to calculate myotonometrics properties of the muscle. It is a non-invasive method to calculate the muscle tone. The investigators obtained many parameters like muscle stiffness, frequency and decrement. | During treatment at 35 min. | 
| Muscle tone post-treatment | This outcome measure is obtained by a device named MyotonPro. It is a commercial device made to calculate myotonometrics properties of the muscle. It is a non-invasive method to calculate the muscle tone. The investigators obtained many parameters like muscle stiffness, frequency and decrement. | Post-treatment at 42min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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H-reflex, TENS, Tone