Healthy SubjectsNCT06936579
Cortical Effects of Peripheral Proprioceptive Stimulation on the Motor Evoked Potentials of the Limbs
A study testing proprioceptive stimulation in people with Healthy Subjects, run by Facultat de ciencies de la Salut Universitat Ramon Llull at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- proprioceptive stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSpain
- Study dates
- 20 May 2025to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Pedro Victor López Plaza
Barcelona
Pedro V López, 932 53 32 56, pedrovictorlp@blanuqerna.url.edu
Pedro Victor López Plaza
About this study
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.
Read the 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.
- Conditions
- Healthy Subjects
- Being tested
- proprioceptive stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proprioceptive stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Condition without proprioceptive stimulation: | No intervention | Participants will not receive the stimulus, and MEP activity will be recorded under the same motor cortex stimulation conditions. |
| Condition with proprioceptive stimulation 1 | Experimental | 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. Receives: Device: proprioceptive stimulation |
| Condition with proprioceptive stimulation 2 | Active comparator | Participants will receive proprioceptive stimulation continuously during the application of TMS pulses while MEP activity is recorded. Receives: Device: proprioceptive stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor evoked potentials (MEPs)
transcranial magnetic stimulation (TMS)
Measured: 45 minuts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start20 May 2025 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will serve as their own control and will be assessed under both stimulation (experimental) and no-stimulation (control) conditions
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Facultat de ciencies de la Salut Universitat Ramon Llull
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Victor López Plaza, Facultat de ciencies de la Salut Universitat Ramon Llull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936579
- Sponsor's protocol ID
- 2025-04-07
- Status last verified
- Apr 2025
- First submitted
- 12 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Effects of Peripheral Proprioceptive Stimulation on the Motor Evoked Potentials of the Limbs
- ClinicalTrials.gov ID
- NCT06936579
- Acronym / sponsor ID
- 2025-04-07
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Facultat de ciencies de la Salut Universitat Ramon LlullUniversity, hospital or other
- Study start
- 20 May 2025 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Each participant will serve as their own control and will be assessed under both stimulation (experimental) and no-stimulation (control) conditions
| Arm | Type | Receives |
|---|---|---|
| Condition without proprioceptive stimulation: | No intervention | –Participants will not receive the stimulus, and MEP activity will be recorded under the same motor cortex stimulation conditions. |
| Condition with proprioceptive stimulation 1 | Experimental | Device: proprioceptive stimulationParticipants 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 | Active comparator | Device: proprioceptive stimulationParticipants will receive proprioceptive stimulation continuously during the application of TMS pulses while MEP activity is recorded. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| proprioceptive stimulationCondition 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. | Device | Condition with proprioceptive stimulation 1, Condition with proprioceptive stimulation 2 |
Primary outcome
Motor evoked potentials (MEPs)
Time frame: 45 minuts
transcranial magnetic stimulation (TMS)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Healthy Subjects
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing proprioceptive stimulation in people with Healthy Subjects, run by Facultat de ciencies de la Salut Universitat Ramon Llull at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pedro V López Plaza (932 53 32 56, pedrovictorlp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor evoked potentials (MEPs) (time frame: 45 minuts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.