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

Spasticity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02718989
• Other study ID #: ddsm25
• Status: Not yet recruiting
• Phase: N/A
• First received: March 3, 2016
• Last updated: May 25, 2017
• Start date: June 2017
• Est. completion date: October 2017

Study information

• Verified date: May 2017
• Source: University of Castilla-La Mancha
• Contact: Diego Serrano-Muñoz, MsC
• Phone: 0034 925247700
• Email: dserrarno[@]sescam.jccm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Spasticity

Intervention

Device:
• Transcutaneous Electrical Stimulation
TENS transcutaneous electrical stimulation over the back the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
• 10Kilohertz (KHz)
10 KHz transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
• Sham stimulation
Sham transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

Locations

Country	Name	City	State
Spain	Diego Serrano-Muñoz	Talavera de la reina	Castilla-La Mancha

Sponsors (1)

Lead Sponsor	Collaborator
University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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