- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06936579
Cortical Effects of Peripheral Proprioceptive Stimulation on the Motor Evoked Potentials of the Limbs
Through motor muscle potentials, we will observe how a peripheral somatosensory mechanical stimulus on key limb musculature communicates signals via afferent sensory fibers that encode proprioceptive signals from muscle spindles (particularly type Ia fibers) to the somatosensory cortex at rest, confirming the integrative hypothesis of movement.
These results would support interventions aimed at addressing sensory deafferentation present in multiple health conditions related to movement disorders, where disuse or immobilization lead to changes in movement patterns and a decrease in neuronal activation in somatosensory cortex areas involved in constructing voluntary movement.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objective: To evaluate whether a proprioceptive stimulus applied to the limb of healthy subjects activates the corticospinal pathway, compared to a condition without stimulation, through the analysis of motor evoked potentials (MEPs).
Methods: Experimental and crossover. Each participant will serve as their own control and will be assessed under both stimulation (experimental) and no-stimulation (control) conditions.The stimulus will consist of intermittent mechanical pressure on the skin located at the neuromuscular motor points (NMPs) of the upper limb (biceps muscle (B) and wrist extensors (WE)) and the lower limb (rectus femoris of the quadriceps (RFQ) and tibialis anterior (TA).Motor evoked potentials (MEPs) will be recorded from the B, WE, RFQ, and TA muscles using transcranial magnetic stimulation (TMS).The optimal stimulation point (hotspot-the area where TMS generates the highest MEP) will be identified individually for the B, WE, RFQ, and TA muscles.Participants will be recruited at the facilities of the Faculty of Physiotherapy and Nursing of Castilla-La Mancha University (UCLM), in collaboration with the Toledo Physiotherapy Research Group (GIFTO) and the Faculty of Health Sciences, Blanquerna - Ramon Llull University.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pedro V López Plaza
- Phone Number: 932 53 32 56
- Email: pedrovictorlp@gmail.com
Study Locations
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-
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Barcelona, Spain
- Pedro Victor López Plaza
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Contact:
- Pedro V López
- Phone Number: 932 53 32 56
- Email: pedrovictorlp@blanuqerna.url.edu
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Principal Investigator:
- Pedro Victor López Plaza
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Sub-Investigator:
- Julio Gómez Soriano
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Sub-Investigator:
- Lorenzo Escutia
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Sub-Investigator:
- Ismael Ordoñez
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Good health status with no history of neuromuscular injuries, surgical interventions, or trauma affecting the central or peripheral nervous system.
Not currently taking drugs or medications known to affect the central nervous system, and not pregnant at the time of testing.
No metallic or electronic implants and no history of epilepsy.
(Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Condition without proprioceptive stimulation:
Participants will not receive the stimulus, and MEP activity will be recorded under the same motor cortex stimulation conditions.
|
|
|
Experimental: Condition with proprioceptive stimulation 1
Participants will receive proprioceptive stimulation through the output plunger, applied continuously for 15 seconds, with 20-second rest intervals, over a total duration of 5 minutes.
MEP activity will then be recorded via motor cortex stimulation.
|
Condition without proprioceptive stimulation: Participants will not receive the stimulus, and MEP activity will be recorded under the same motor cortex stimulation conditions. Condition with proprioceptive stimulation 1: Participants will receive proprioceptive stimulation through the output plunger, applied continuously for 15 seconds, with 20-second rest intervals, over a total duration of 5 minutes. MEP activity will then be recorded via motor cortex stimulation. Condition with proprioceptive stimulation 2: Participants will receive proprioceptive stimulation continuously during the application of TMS pulses while MEP activity is recorded. |
|
Active Comparator: Condition with proprioceptive stimulation 2
Participants will receive proprioceptive stimulation continuously during the application of TMS pulses while MEP activity is recorded.
|
Condition without proprioceptive stimulation: Participants will not receive the stimulus, and MEP activity will be recorded under the same motor cortex stimulation conditions. Condition with proprioceptive stimulation 1: Participants will receive proprioceptive stimulation through the output plunger, applied continuously for 15 seconds, with 20-second rest intervals, over a total duration of 5 minutes. MEP activity will then be recorded via motor cortex stimulation. Condition with proprioceptive stimulation 2: Participants will receive proprioceptive stimulation continuously during the application of TMS pulses while MEP activity is recorded. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motor evoked potentials (MEPs)
Time Frame: 45 minuts
|
transcranial magnetic stimulation (TMS)
|
45 minuts
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025-04-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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