Modulation of H-reflex After Application of Electric Currents in Healthy People
1 other identifier
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2016
CompletedFirst Posted
Study publicly available on registry
March 24, 2016
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedMay 30, 2017
May 1, 2017
2 months
March 3, 2016
May 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
Baseline muscle tone
Baseline at 0 min.
Muscle tone during treatment
During treatment at 35 min.
Muscle tone post-treatment
Post-treatment at 42min
Study Arms (3)
10 Kilohertz (KHz)
EXPERIMENTALTranscutaneous 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 Electrical Stimulation
EXPERIMENTALTranscutaneous 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
Sham stimulation
SHAM COMPARATORElectrodes 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.
Interventions
TENS transcutaneous electrical stimulation over the back the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
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)
Eligibility Criteria
You may qualify if:
- Participants will be volunteer healthy students of Physiotherapy, University of Castilla - La Mancha, older than 18 years.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diego Serrano-Muñoz
Talavera de la Reina, Castille-La Mancha, 45600, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diego Serrano-Muñoz, MsC
Hospital Nacional de Parapléjicos de Toledo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2016
First Posted
March 24, 2016
Study Start
June 1, 2017
Primary Completion
August 1, 2017
Study Completion
October 1, 2017
Last Updated
May 30, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will share