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Clinical Trials/NCT04241406
NCT04241406
Completed
Not Applicable

Transcutaneous Spinal Cord Stimulation in Healthy Subjects to Activate Central Pattern Generator: Double-blind, Randomised, Controlled Clinical Trial.

University of Castilla-La Mancha3 sites in 1 country15 target enrollmentJanuary 30, 2019
ConditionsMotor Activity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Motor Activity
Sponsor
University of Castilla-La Mancha
Enrollment
15
Locations
3
Primary Endpoint
Baseline Motor evoked potential (MEP)
Status
Completed
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 30, 2019
End Date
March 31, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
University of Castilla-La Mancha
Responsible Party
Sponsor

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 lumbar área.
  • Osteosynthesis material in the upper limb.
  • Diabetes.
  • 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.

Outcomes

Primary Outcomes

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).

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).

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).

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 Outcomes

  • Baseline Strength(Baseline at 0 min.)
  • Post-treatment Strength(At 8 min after treatment.)

Study Sites (3)

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