Transcutaneous Spinal Cord Stimulation in Healthy Subjects to Activate Central Pattern Generator
1 other identifier
interventional
15
1 country
3
Brief Summary
The purpose of this study is to determinate whether the application of transcutaneous spinal cord stimulation produce changes in the excitability of alpha moto neurone in healthy volunteers. Moreover evidence whether the effect of the electric currents can increase muscle strength.
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 Jan 2019
3 active sites
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
Study Start
First participant enrolled
January 30, 2019
CompletedFirst Submitted
Initial submission to the registry
January 22, 2020
CompletedFirst Posted
Study publicly available on registry
January 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedMay 1, 2020
April 1, 2020
1 year
January 22, 2020
April 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Baseline Motor evoked potential (MEP)
The action potential elicited by transcranial magnetic stimulation of the motor cortex through the scalp. EMG response will be recorded by surface electrodes (Signa lConditioning Electrodes v2.3, Delsys Inc., USA) fixed in quadriceps and tibialis anterior muscles. by the SENIAM protocol (www.seniam.org).
baseline at 0 min.
During treatment Motor evoked potential (MEP)
The action potential elicited by transcranial magnetic stimulation of the motor cortex through the scalp. EMG response will be recorded by surface electrodes (Signa lConditioning Electrodes v2.3, Delsys Inc., USA) fixed in quadriceps and tibialis anterior muscles. by the SENIAM protocol (www.seniam.org).
During treatment at 5 min.
Post-treatment 1 Motor evoked potential (MEP)
The action potential elicited by transcranial magnetic stimulation of the motor cortex through the scalp. EMG response will be recorded by surface electrodes (Signa lConditioning Electrodes v2.3, Delsys Inc., USA) fixed in quadriceps and tibialis anterior muscles. by the SENIAM protocol (www.seniam.org).
At 2 min after treatment.
Post-treatment 2 Motor evoked potential (MEP)
The action potential elicited by transcranial magnetic stimulation of the motor cortex through the scalp. EMG response will be recorded by surface electrodes (Signa lConditioning Electrodes v2.3, Delsys Inc., USA) fixed in quadriceps and tibialis anterior muscles. by the SENIAM protocol (www.seniam.org).
At 4 min after treatment.
Secondary Outcomes (2)
Baseline Strength
Baseline at 0 min.
Post-treatment Strength
At 8 min after treatment.
Study Arms (2)
transcutaneous spinal cord stimulation
EXPERIMENTALTranscutaneous application of electrical (biphasic current, 1ms, 30Hz) stimulation over the back for a 10 minutes session.The intensity of the current will increase until motor reflex threshold. If it will not possible, intensity will be increase until participants report a "strong but comfortable" sensation. Transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands).
sham stimulation
EXPERIMENTALElectrodes are placed over the back for a 10 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing current intensity during 30 second and decrease intensity subsequently. Sham transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands).
Interventions
Electrodes are placed over the back for a 10 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing current intensity during 30 second and decrease intensity subsequentl
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 lumbar área.
- 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 (3)
Julio
Toledo, 45001, Spain
Álvaro
Toledo, 45001, Spain
Diego Serrano-Muñoz
Toledo, 45004, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julio Gómez-Soriano, PhD
Castilla-La Mancha University
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
January 22, 2020
First Posted
January 27, 2020
Study Start
January 30, 2019
Primary Completion
February 3, 2020
Study Completion
March 31, 2020
Last Updated
May 1, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share