rTMS Over S1 Enhance Motor Learning in Healthy People

NCT ID: NCT06262425

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-20
• Study Completion Date: 2025-07-15

Brief 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.

Detailed 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.

Conditions

Transcranial Magnetic Stimulation; Motor Learning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

repetitive Transcranial Magnetic Stimulation over primary somatosensory cortex

Participants in the experimental group will receive 5 weekly sessions of repetitive Transcranial Magnetic Stimulation (rTMS) for two weeks. An excitatory stimulation over the primary somatosensory area corresponding to the dominant hand will be applied. For this purpose, the motor area will be localized and a coil will be placed 2 cm posterior to it. An isolated pulse will be applied to the motor area to ensure that the coil is not placed over the motor area using 110% of the motor resting threshold. After this, 22 trains of 10 Hz at an intensity of 90% of the motor resting threshold will be applied for 4 seconds, with a rest between series of 10 seconds (a total of 880 pulses). After the stimulation, participants will train with the Forced Response training program for a total of 500 correct repetitions and the Purdue Pegboard Test with 4 repetitions for right hand, left hand and both hands.

Group Type: EXPERIMENTAL

repetitive Transcranial Magnetic Stimulation over primary somatosensory cortex

Intervention Type: DEVICE

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

Participants in the active comparator group will receive 5 weekly sessions of repetitive Transcranial Magnetic Stimulation (rTMS) for two weeks. An excitatory stimulation over the primary motor cortex corresponding to the dominant hand will be applied. For this purpose, the motor area will be localized, and an isolated pulse will be applied to the motor area to ensure that the coil is placed over the motor area using 100% of the motor resting threshold. After this, 22 trains of 10 Hz at an intensity of 90% of the motor resting threshold will be applied for 4 seconds, with a rest between series of 10 seconds (a total of 880 pulses). After the stimulation, participants will train with the Forced Response training program for a total of 500 correct repetitions and the Purdue Pegboard Test with 4 repetitions for right hand, left hand and both hands.

Group Type: ACTIVE_COMPARATOR

repetitive Transcranial Magnetic Stimulation over primary motor cortex

Intervention Type: DEVICE

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

Participants in the sham group will receive 5 weekly sessions of sham repetitive Transcranial Magnetic Stimulation (rTMS) for two weeks.To achieve the placebo, the localization of the area to be stimulated will be carried out but the coil will be placed in a vertical position so the current will not go through the skull and the patient will just feel the vibration, communicating to the participant that it is likely that during the stimulation process he/she will not feel anything. After the sham stimulation, participants will train with the Forced Response training program for a total of 500 correct repetitions and the Purdue Pegboard Test with 4 repetitions for right hand, left hand and both hands.

Group Type: SHAM_COMPARATOR

sham repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

It will be applied a sham stimulation with the same protocol that pretends to create the illusion of being stimulated

Interventions

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

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Neuron, Spain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alfredo Lerín Calvo, PhD student

Role: PRINCIPAL_INVESTIGATOR

Neuron, Spain

Locations

Neuron

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

ALC001NR004

Identifier Type: -

Identifier Source: org_study_id