Motor Activity Clinical Trial
Official title:
Transcutaneous Spinal Cord Stimulation in Healthy Subjects to Activate Central Pattern Generator: Double-blind, Randomised, Controlled Clinical Trial.
NCT number | NCT04241406 |
Other study ID # | aamg295 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 30, 2019 |
Est. completion date | March 31, 2020 |
Verified date | April 2020 |
Source | University of Castilla-La Mancha |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | March 31, 2020 |
Est. primary completion date | February 3, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Álvaro | Toledo | |
Spain | Diego Serrano-Muñoz | Toledo | |
Spain | Julio | Toledo |
Lead Sponsor | Collaborator |
---|---|
University of Castilla-La Mancha | Hospital Nacional de Parapléjicos de Toledo |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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 | Baseline Strength | 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. | Baseline at 0 min. | |
Secondary | Post-treatment Strength | 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. | At 8 min after treatment. |
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