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Transcutaneous Spinal Cord Stimulation in Healthy Subjects to Activate Central Pattern Generator

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ClinicalTrials.gov Identifier: NCT04241406
Recruitment Status : Completed
First Posted : January 27, 2020
Last Update Posted : May 1, 2020
Sponsor:
Collaborator:
Hospital Nacional de Parapléjicos de Toledo
Information provided by (Responsible Party):
University of Castilla-La Mancha

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.

Condition or disease Intervention/treatment Phase
Motor Activity Device: Transcutaneous spinal cord stimulation Not Applicable

Detailed Description:
In the last years several experimental studies have evidenced that the transcutaneous spinal cord stimulation (tSCS) can evoque spinal reflex activity. The activation of propioceptive afferent would then activated motoneurons innervated at the same metameric and adjacent levels. The possibility of activating neural networks with non-invasive stimulation method opens a therapeutic window for the treatment of different neurological disorders. So the purpose of this study is quantify the modulation of the excitability of alpha motor neurone when the application of the current is in the central nervous system compared with a sham group.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcutaneous Spinal Cord Stimulation in Healthy Subjects to Activate Central Pattern Generator: Double-blind, Randomised, Controlled Clinical Trial.
Actual Study Start Date : January 30, 2019
Actual Primary Completion Date : February 3, 2020
Actual Study Completion Date : March 31, 2020

Arm Intervention/treatment
Experimental: transcutaneous spinal cord stimulation

Transcutaneous 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).

Device: Transcutaneous spinal cord stimulation
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
Other Name: tSCS

Experimental: sham stimulation

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 subsequently.

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

Device: Transcutaneous spinal cord stimulation
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
Other Name: tSCS




Primary Outcome Measures :
  1. Baseline Motor evoked potential (MEP) [ Time Frame: baseline at 0 min. ]
    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).

  2. During treatment Motor evoked potential (MEP) [ Time Frame: During treatment at 5 min. ]
    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).

  3. Post-treatment 1 Motor evoked potential (MEP) [ Time Frame: At 2 min after treatment. ]
    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).

  4. Post-treatment 2 Motor evoked potential (MEP) [ Time Frame: At 4 min after treatment. ]
    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).


Secondary Outcome Measures :
  1. Baseline Strength [ Time Frame: Baseline at 0 min. ]
    Hand dynamometer will be used to measure muscle strength. 3 trial of 3 second of isometric muscle contraction of quadriceps and tibialis anterior will be carried.

  2. Post-treatment Strength [ Time Frame: At 8 min after treatment. ]
    Hand dynamometer will be used to measure muscle strength. 3 trial of 3 second of isometric muscle contraction of quadriceps and tibialis anterior will be carried.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241406


Locations
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Spain
Julio
Toledo, Spain, 45001
Álvaro
Toledo, Spain, 45001
Diego Serrano-Muñoz
Toledo, Spain, 45004
Sponsors and Collaborators
University of Castilla-La Mancha
Hospital Nacional de Parapléjicos de Toledo
Investigators
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Principal Investigator: Julio Gómez-Soriano, PhD Castilla-La Mancha University
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Responsible Party: University of Castilla-La Mancha
ClinicalTrials.gov Identifier: NCT04241406    
Other Study ID Numbers: aamg295
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
transcutaneous spinal cor stimulation
neuromodulation
motor activity