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

NCT ID: NCT04241406

Last Updated: 2020-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-30
• Study Completion Date: 2020-03-31

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.

Conditions

Motor Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Transcutaneous spinal cord stimulation

Intervention Type: DEVICE

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

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).

Group Type: EXPERIMENTAL

Transcutaneous spinal cord stimulation

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

tSCS

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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Nacional de Parapléjicos de Toledo

OTHER

Sponsor Role: collaborator

University of Castilla-La Mancha

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julio Gómez-Soriano, PhD

Role: PRINCIPAL_INVESTIGATOR

Castilla-La Mancha University

Locations

Julio

Toledo, , Spain

Álvaro

Toledo, , Spain

Diego Serrano-Muñoz

Toledo, , Spain

Countries

Spain

Other Identifiers

aamg295

Identifier Type: -

Identifier Source: org_study_id