rTMS Over S1 Enhance Motor Learning in Healthy People

Transcranial Magnetic Stimulation Clinical Trial

Official title:

Comparison of Different Repetitive Transcranial Magnetic Stimulation Protocols for Motor Learning in Healthy People. A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06262425
• Other study ID #: ALC001NR004
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2024
• Est. completion date: September 15, 2025

Study information

• Verified date: February 2024
• Source: Neuron, Spain
• Contact: Alfredo Lerín Calvo, PhD student
• Phone: 620187457
• Email: alfre_lerin[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effectiveness of different repetitive Transcranial Magnetic Stimulation protocols for enhancing motor learning in healthy peolple.

Description:

This randomized clinical trial aims to compare the effectiveness of different repetitive Transcranial Magnetic Stimulation (rTMS) protocols in enhancing motor learning in healthy individuals. It focuses on two key brain areas: the primary motor cortex (M1) and the primary somatosensory cortex (S1), recognized for their roles in motor skill acquisition and execution.

Motor learning involves two distinct neural networks: the associative/premotor and sensorimotor networks. Studies suggest that the associative/premotor network predominates initially, followed by the sensorimotor network. M1 stores movement patterns, whereas S1 appears crucial for initial motor learning and movement adaptation.

rTMS, a non-invasive technique modulating neuronal excitability, has been used to improve motor function in patients with brain injuries. However, its effectiveness in healthy individuals has been variable, especially when stimulating M1 and S1. Prior research suggests that inhibitory rTMS in S1 may influence motor learning, but findings regarding its excitatory effect and comparison with M1 stimulation are mixed.

The primary hypothesis posits that excitatory rTMS in S1 will yield superior motor learning improvements compared to M1 stimulation in healthy individuals. The secondary hypothesis predicts improvements independent of the stimulated area.

The study will involve healthy participants, utilizing tests for accuracy and time. Methodology includes randomization, blind evaluation, and rTMS application based on assigned groups.

With a sample size of 35 subjects per group, data will be analyzed using parametric and non-parametric statistical tests to compare the effects of rTMS on M1 and S1 concerning motor learning in healthy subjects. Results will be considered significant with p < 0.05, and effect size will be evaluated.

This trial aims to provide clarity on the effectiveness of excitatory rTMS in specific brain areas to enhance motor learning in individuals without neurological pathologies, potentially impacting rehabilitation and motor performance.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: September 15, 2025
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Older than 18 years old and younger than 65

Exclusion Criteria:

• Presenting any neurological pathology

• Pain during the study

• Any contraindications to rTMS, such as metal implants, history of epileptic seizures or taking medication that lowers the seizure threshold

Related Conditions & MeSH terms

• Motor Learning
• Transcranial Magnetic Stimulation

Intervention

Device:
• repetitive Transcranial Magnetic Stimulation over primary somatosensory cortex
It will be applyed a magnetic field over the Somatosensory cortex of the patient that pretends to hiperexcite the membrans of the neurons inthis area to enhance motor learning
• repetitive Transcranial Magnetic Stimulation over primary motor cortex
It will be applyed a magnetic field over the primary motor cortex of the patient that pretends to hiperexcite the membrans of the neurons inthis area to enhance motor learning
• sham repetitive Transcranial Magnetic Stimulation
It will be applied a sham stimulation with the same protocol that pretends to create the illusion of being stimulated

Locations

Country	Name	City	State
Spain	Neuron	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Neuron, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in accuracy	Accuracy in associating one letter of the keyboard with a letter from the Phoenician alphabet presented in the screen. It will be measured by using the software PsychoPy, that has been used in other studies for measuring motor learning in an indirect way.	Change from Baseline to 5 days and 10 days in accuracy
Secondary	Change in reaction time speed	Reaction time for responding correctly the association between one letter of the keyboard and a letter from the Phoenician alphabet presented in the screen. It will be measured by using the software PsychoPy, that has been used in other studies for measuring motor learning in an indirect way.	Change from Baseline to 5 days and 10 days in reaction time speed
Secondary	Change in pegs placed in 30 seconds	Number of pegs placed in a pegboard in 30 seconds will be measured. Patients will use just right hand first, after they will use just their left hand and finally with both hand at same time. This procedure will be repeated and average pegs placed in each condition will be noted. Purdue Pegboard Test will be used for measuring.	Change from Baseline to 5 days and 10 days in days placed in 30 seconds