Transcranial Magnetic Stimulation on Somtosensory Cortex Enhances Motor Learning in People With Stroke

NCT05467657 | Completed

• 1 other identifier: ALC001NR001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to know the efficacy about the application of repetitive transcranial magnetic stimulation (rTMS) on the somatosensory cortex (S1) to enhance motor function in people with stroke.

Conditions

Transcranial Magnetic Stimulation; Stroke; Motor Learning

Keywords

Transcranial magnetic stimulation; Stroke; Motor learning; Somatosensory cortex; Motor function

Outcome Measures

Primary Outcomes (1)

• Change in electroencephalographic activity

  The electrical signal evoked by the motor cortex when realizing a movement. It will be measured with an electroencephalograph

  Change from Baseline in electroencephalographic activity at 4 weeks

Secondary Outcomes (4)

• Changes in Resting Motor Treshold

  Change from Baseline in Resting Motor Treshold at 4 weeks

• Changes in Motor learning

  Change from Baseline in Motor learning at 4 weeks

• Changes in Sensitivity

  Change from Baseline in Sensitivity at 4 weeks

• Changes in Esterognosia

  Change from Baseline in esterognosia at 4 weeks

Study Arms (2)

repetitive transcranial magnetic stimulation

EXPERIMENTAL

Participants in the experimental group will receive one hour of rehabilitation therapy daily with 30 minutes of Task Oriented Training (TOT) and 30 minutes of Robotic-Assisted Therapy (RAT), 5 days per week, and repetitive Transcranial Magnetic Stimulation (rTMS) will be applied. This process will comprise 5 weekly sessions of excitatory stimulation over the primary somatosensory area of the participant's affected side. For this purpose, the motor area will be localised 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, 24 trains of 5 Hz at an intensity of 90% of the motor resting threshold will be applied for 10 seconds, with a rest between series of 5 seconds (a total of 1200 pulses).

Device: repetitive Transcranial Magnetic Stimulation

Sham repetitive transcranial magnetic stimulation

SHAM COMPARATOR

The control group treatment will consist of a daily one-hour session of 30 minutes of task-oriented training (TOT) and 30 minutes of robotic-assisted therapy (RAT), for 5 days per week, to which the repetitive Transcranial Magnetic Stimulation (rTMS) placebo treatment will be added. To achieve the placebo, the localisation of the area to be stimulated will be carried out but the coil will be placed in a vertical position so the current wil 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.

Device: repetitive Transcranial Magnetic Stimulation

Interventions

repetitive Transcranial Magnetic Stimulation 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

Sham repetitive transcranial magnetic stimulation; repetitive transcranial magnetic stimulation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having suffered an ischaemic or haemorrhagic stroke with more than 3 months of evolution
• Presenting a score \>21 points on the Mini-mental State Examination scale.

You may not qualify if:

• Severe impairment of upper limb motor function (\<15 points on the Fugl-Meyer Assessment Upper Extremity scale)
• Any contraindications to rTMS, such as metal implants, history of epileptic seizures or taking medication that lowers the seizure threshold
• Previous history of neurological pathology.

Sponsors & Collaborators

• Neuron, Spain: lead
• Centro Superior de Estudios Universitarios La Salle: collaborator

Study Sites (2)

Neuron Chamberí

Madrid, Madrid, 28003, Spain

Location

Neuron Madrid Rio

Madrid, Madrid, 28045, Spain

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Alfredo Lerín Calvo, PhD student

  Neuron, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Model Details: The experimental group will recive conventional therapy and repetitive transcranial magnetic stimulation over somatosensory cortex, and control group will receive conventional therapy and sham repetitive transcranial stimulation

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: July 20, 2022
• Study Start: November 15, 2023
• Primary Completion: November 22, 2025
• Study Completion: January 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)