Clinical trial NCT06262425: rTMS Over S1 Enhance Motor Learning in Healthy People
Official title: Comparison of Different Repetitive Transcranial Magnetic Stimulation Protocols for Motor Learning in Healthy People. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transcranial Magnetic Stimulation
Motor Learning
Keywords: Transcranial magnetic stimulation
Motor learning
Somatosensory cortex
Motor function
Lead sponsor: Neuron, Spain
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in accuracy
timeFrame: Change from Baseline to 5 days and 10 days in accuracy
Secondary outcomes:
measure: Change in reaction time speed
timeFrame: Change from Baseline to 5 days and 10 days in reaction time speed
measure: Change in pegs placed in 30 seconds
timeFrame: Change from Baseline to 5 days and 10 days in days placed in 30 seconds
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Neuron
Study officials:
affiliation: Neuron, Spain
name: Alfredo Lerín Calvo, PhD student
role: PRINCIPAL_INVESTIGATOR
References: