An interventional study of Transcutaneous Electrical Stimulation and 10Kilohertz (KHz) in Spasticity, sponsored by University of Castilla-La Mancha. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-30.
Sponsored by University of Castilla-La Mancha · Not applicable, Interventional, and Treatment
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
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.
704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.
This study's planned enrollment of 30 is below the median of 36 across 525 interventional studies indexed under Muscle Spasticity.
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Exclusion Criteria:
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 · Device: 10Kilohertz (KHz)
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
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
TENS transcutaneous electrical stimulation over the back the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Also known as: TENS
10 KHz transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Sham transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
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.
Time frame: 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.
Time frame: 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.
Time frame: Immediately after treatment at 40 min.
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.
Time frame: 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.
Time frame: 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.
Time frame: Post-treatment at 42min
Plan to share: Yes
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University of Castilla-La Mancha