Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2020
Source University of Castilla-La Mancha
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Spain Álvaro Toledo
Spain Diego Serrano-Muñoz Toledo
Spain Julio Toledo

Sponsors (2)

Lead Sponsor Collaborator
University of Castilla-La Mancha Hospital Nacional de Parapléjicos de Toledo

Country where clinical trial is conducted

Spain, 

Outcome

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.
See also
  Status Clinical Trial Phase
Completed NCT06315036 - Effects of Developmental Gymnastics on Preschoolers' Motor Skills N/A
Completed NCT02915913 - Effects of Exercise Training on Cognitive Function and Neurotrophic Factors in Overweight Adults N/A
Terminated NCT02936726 - Examining Exercise, Health Coaching and Meditation for University Employees N/A
Completed NCT03162484 - Physical Activity and Chronic Acquired Brain Injury N/A
Completed NCT02329262 - A Skills-based RCT for Physical Activity Using Peer Mentors N/A
Completed NCT02158130 - Effects of Aerobic Exercise Detraining N/A
Completed NCT01188044 - Validating Accelerometers to Study Physical Activity of Toddlers N/A
Terminated NCT01404039 - Investigating Motor Cortex Processing for Pain Modulation Phase 1
Completed NCT01697124 - The Children in Action Feasibility Study N/A
Not yet recruiting NCT04035863 - Effects of Photobiomodulation on Superficial Sensitivity and Muscle Activity of Individuals With Myelomeningocele N/A
Completed NCT03695523 - PLAY (PhysicaL ActivitY) Policy Study N/A
Active, not recruiting NCT05012241 - The Reliability of the Nine Hole Peg Test in Patients With Multiple Sclerosis
Recruiting NCT03826030 - Transcranial Direct Current Stimulation for Post-stroke Motor Recovery Phase 2
Completed NCT05033197 - Physical Activity, Cognition, Motor Skills, and Well-beings N/A
Completed NCT03146169 - Training Program for Community Health Campaign: Fitter Families Project N/A
Completed NCT03166020 - Evaluation of a Video-ludic Re-education of the Paretic Upper Limb in Chronic Hemipartic Patients Post Cerebral Vascular Accident N/A
Recruiting NCT02264275 - Influence of Aerobic Exercise Training (AET) on Inflammatory Bowel Disease (IBD) in Children and Adolescents N/A
Completed NCT02432924 - Using Combined Instantaneous and Multidimensional Feedback to Support a Change in Physical Activity Behaviour N/A
Completed NCT01697475 - Text-Messaging to Motivate Walking in Older African Americans N/A
Completed NCT04547569 - Somesthesic Role of the Ventro-lateral Prefrontal Cortex in Speech Motor Learning N/A