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

Primary Purpose

Spasticity

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Transcutaneous Electrical Stimulation
10Kilohertz (KHz)
Sham stimulation
Sponsored by
University of Castilla-La Mancha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spasticity focused on measuring H-reflex, TENS, Tone

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Diego Serrano-Muñoz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

10 Kilohertz (KHz)

Transcutaneous Electrical Stimulation

Sham stimulation

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 3, 2016
Last Updated
May 25, 2017
Sponsor
University of Castilla-La Mancha
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1. Study Identification

Unique Protocol Identification Number
NCT02718989
Brief Title
Modulation of H-reflex After Application of Electric Currents in Healthy People
Official Title
Modulation of H-reflex After Application of Electric Currents in Healthy People. Effects on Myotonometer Properties.A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2017 (Anticipated)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Castilla-La Mancha

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasticity
Keywords
H-reflex, TENS, Tone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
10 Kilohertz (KHz)
Arm Type
Experimental
Arm Description
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.
Arm Title
Transcutaneous Electrical Stimulation
Arm Type
Experimental
Arm Description
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
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electrical Stimulation
Other Intervention Name(s)
TENS
Intervention Description
TENS transcutaneous electrical stimulation over the back the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Intervention Type
Device
Intervention Name(s)
10Kilohertz (KHz)
Intervention Description
10 KHz transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Intervention Type
Device
Intervention Name(s)
Sham stimulation
Intervention Description
Sham transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Primary Outcome Measure Information:
Title
Baseline H reflex
Description
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.
Title
During treatment H reflex
Description
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.
Title
Post treatment H reflex
Description
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.
Secondary Outcome Measure Information:
Title
Baseline muscle tone
Description
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.
Title
Muscle tone during treatment
Description
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.
Title
Muscle tone post-treatment
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diego Serrano-Muñoz, MsC
Phone
0034 925247700
Ext
783
Email
dserrarno@sescam.jccm.es
First Name & Middle Initial & Last Name or Official Title & Degree
Julio Gómez-Soriano, PhD
Phone
0034 925268800
Ext
5845
Email
julio.soriano@uclm.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diego Serrano-Muñoz, MsC
Organizational Affiliation
Hospital Nacional de Parapléjicos de Toledo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diego Serrano-Muñoz
City
Talavera de la reina
State/Province
Castilla-La Mancha
ZIP/Postal Code
45600
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Muñoz, Msc
Phone
0034 600237620
Email
Dserrarno@sescam.jccm.es

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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