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

Sponsor
University of Castilla-La Mancha (Other)
Overall Status
Unknown status
CT.gov ID
NCT02718989
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
4
Anticipated Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Device: Transcutaneous Electrical Stimulation
  • Device: 10Kilohertz (KHz)
  • Device: Sham stimulation
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Modulation of H-reflex After Application of Electric Currents in Healthy People. Effects on Myotonometer Properties.A Pilot Study
Anticipated Study Start Date :
Jun 1, 2017
Anticipated Primary Completion Date :
Aug 1, 2017
Anticipated Study Completion Date :
Oct 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 10 Kilohertz (KHz)

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
TENS transcutaneous electrical stimulation over the back the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Other Names:
  • TENS

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

    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
    TENS transcutaneous electrical stimulation over the back the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
    Other Names:
  • TENS

    		•
    Sham Comparator: Sham 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
    Sham transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

    Outcome Measures

    Primary Outcome Measures

    1. Baseline H reflex [baseline at 0 min.]

      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.

    2. During treatment H reflex [During treatment at 33min.]

      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.

    3. Post treatment H reflex [Immediately after treatment at 40 min.]

      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.

    Secondary Outcome Measures

    1. Baseline muscle tone [Baseline at 0 min.]

      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.

    2. Muscle tone during treatment [During treatment at 35 min.]

      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.

    3. Muscle tone post-treatment [Post-treatment at 42min]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Diego Serrano-Muñoz Talavera de la reina Castilla-La Mancha Spain 45600

    Sponsors and Collaborators

    • University of Castilla-La Mancha

    Investigators

    • Principal Investigator: Diego Serrano-Muñoz, MsC, Hospital Nacional de Parapléjicos de Toledo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Castilla-La Mancha
    ClinicalTrials.gov Identifier:
    NCT02718989
    Other Study ID Numbers:
    • ddsm25
    First Posted:
    Mar 24, 2016
    Last Update Posted:
    May 30, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Castilla-La Mancha
    H-reflex
    TENS
    Tone
    Additional relevant MeSH terms:
    Muscle Spasticity

    Study Results

    No Results Posted as of May 30, 2017