Clinical trial NCT04241406: Transcutaneous Spinal Cord Stimulation in Healthy Subjects to Activate Central Pattern Generator
Official title: Transcutaneous Spinal Cord Stimulation in Healthy Subjects to Activate Central Pattern Generator: Double-blind, Randomised, Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Activity
Keywords: transcutaneous spinal cor stimulation
neuromodulation
motor activity
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
Collaborators: name: Hospital Nacional de Parapléjicos de Toledo
First posted: 2020-01-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Baseline Motor evoked potential (MEP)
timeFrame: baseline at 0 min.
measure: During treatment Motor evoked potential (MEP)
timeFrame: During treatment at 5 min.
measure: Post-treatment 1 Motor evoked potential (MEP)
timeFrame: At 2 min after treatment.
measure: Post-treatment 2 Motor evoked potential (MEP)
timeFrame: At 4 min after treatment.
Secondary outcomes:
measure: Baseline Strength
timeFrame: Baseline at 0 min.
measure: Post-treatment Strength
timeFrame: At 8 min after treatment.
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Julio
city: Toledo
country: Spain
facility: Álvaro
city: Toledo
country: Spain
facility: Diego Serrano-Muñoz
Study officials:
affiliation: Castilla-La Mancha University
name: Julio Gómez-Soriano, PhD
role: PRINCIPAL_INVESTIGATOR
References: