Transcranial Magnetic StimulationNCT05467657
Transcranial Magnetic Stimulation on Somtosensory Cortex Enhances Motor Learning in People With Stroke
A study testing repetitive Transcranial Magnetic Stimulation in people with Transcranial Magnetic Stimulation and Stroke, run by Neuron, Spain at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Transcranial Magnetic Stimulation, Stroke, Motor Learning
- What is being tested?
- repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Nov 2023to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Neuron Chamberí
Madrid, Madrid, 28003
Neuron Madrid Rio
Madrid, Madrid, 28045
About this study
Official title: Efficacy of Repetitive Transcranial Magnetic Stimulation of the Somatosensory Cortex on Motor Learning
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.
Read the detailed description
Subjects will attend the Neuron rehabilitation clinic or La Beata Hospital on their own to begin a rehabilitation program. After being recruited for the study and signing informed consent an electroencephalography test (EEG) will be performed to determine the absence of ectopic foci and to reduce risks during the treatment process with repetitive transcranial magnetic stimulation (rTMS).
One assessor will be in charge of carrying out the rest of the neurophysiological tests, so the Resting Motor Treshold (RMT) will be collected. To finalise the assessment, a second evaluator will test sensory aspects with the two-point discrimination test, the Semmes-Wenstein monofilaments, the pinprick test and the sterognosia test, and motor aspects by means of the ARAT test.
Once the assessment is completed, the participant will be assigned to the control or experimental group through a randomisation process carried out by another person in the research group using GraphPad software. 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 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.
Participants in the experimental group will receive one hour of rehabilitation therapy daily with 30 minutes of TOT and 30 minutes of RAT, 5 days per week, and 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 stimulation 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).
Finally, once the treatment period is over, after 20 sessions, the assessment will be carried out again, recording the initial tests in the same order by the same assessors.
A descriptive analysis of the demographic characteristics and the main and secondary variables in the sample will be performed, presenting the continuous variables as Mean ± Standard Deviation (SD), 95% Confidence Interval (CI), while the categorical variables will be presented as Number (n) and Percentage (relative frequency, %). To measure normality, the Kolmogorov-Smirnov test will be used, and if the quantitative variables show a non-normal distribution, they will be described with the median and the interquartile range. Parametric tests (normal distribution) will be chosen for comparison between groups based on the central limit theorem, in case the sample exceeds 30 subjects per group. Therefore, the mixed-model ANCOVA test will be used to analyze the group factor in quantitative variables and the chi-square test for qualitative variables to observe the variability of the intra-group treatment response. A P-value < 0.05 will be accepted as statistically significant.
- Conditions
- Transcranial Magnetic Stimulation, Stroke, Motor Learning
- Being tested
- repetitive Transcranial Magnetic Stimulation
- Keywords
- Transcranial magnetic stimulation, Stroke, Motor learning, Somatosensory cortex, Motor function
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive Transcranial Magnetic StimulationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Device: repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in electroencephalographic activity
The electrical signal evoked by the motor cortex when realizing a movement. It will be measured with an electroencephalograph
Measured: Change from Baseline in electroencephalographic activity at 4 weeks
Secondary outcomes (4)
Changes in Resting Motor Treshold
Electrophysilogic response of the motor cortex after a sensory stimulation. By placing the stimulator coil over the subject's motor cortex, an electrical pulse is passed to activate the upper motor neurons, generating a motor response that is recorded by electromyography in the subject's interosseous musculature. In this way, the excitability of the corticospinal tract can be measured by observing the latency recorded by electromyography.
Measured: Change from Baseline in Resting Motor Treshold at 4 weeks
Changes in Motor learning
Ability to learn or demonstrate the ability to acquire, maintain, modify and control voluntary postures and movement patterns with a goal framed motor behaviour.One way to measure this in neurologically affected subjects is through motor dexterity, as it is a variable derived from motor learning that is more useful in the clinical setting. Because of this, Action Research Arm Test (ARAT) will be used. This test asses the motor dexterity of the patient by 4 subtest based on functional movements (grasping, holding, clamping and gross movement)
Measured: Change from Baseline in Motor learning at 4 weeks
Changes in Sensitivity
It refers to the integration of information received by sensory receptors. It will be measured by the 2 points discrimination test, the Semmes-Weinstein monofilaments and the pinprick test, all of them applyed on tenar eminence of the subject. using an esthesiometer
Measured: Change from Baseline in Sensitivity at 4 weeks
Changes in Esterognosia
It refers to the three-dimensional perception and recognition of an object through active touch. To assess sterognosia, the patient, with eyes closed, must recognise a set of objects presented randomly from the ulnar side of the hand and between the fingers and thumb. The objects used for the test are a pencil, a paper clip, a safety pin, a coin, a button, a pill, a rubber band, a string, a spoon, a bucket and a marble, andthe protocol by Van Heest, House and Putnam, 1993 will be used.
Measured: Change from Baseline in esterognosia at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start15 Nov 2023
- Primary completion22 Nov 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Magnetic StimulationStudies 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
- Parallel groups
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuron, Spain
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Superior de Estudios Universitarios La Salle
- Responsible party
- Principal investigator, Alfredo Lerín Calvo, Neuron, Spain
- Investigators
- Alfredo Lerín Calvo, PhD student, Principal investigator, Neuron, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467657
- Sponsor's protocol ID
- ALC001NR001
- Status last verified
- Dec 2025
- First submitted
- 4 Oct 2021
- Last updated
- 20 Mar 2026
- 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 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Repetitive Transcranial Magnetic Stimulation of the Somatosensory Cortex on Motor Learning
- ClinicalTrials.gov ID
- NCT05467657
- Acronym / sponsor ID
- ALC001NR001
- Conditions
- Transcranial Magnetic Stimulation, Stroke, Motor Learning
- Keywords
- Transcranial magnetic stimulation, Stroke, Motor learning, Somatosensory cortex, Motor function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Neuron, SpainUniversity, hospital or other
- Collaborators
- Centro Superior de Estudios Universitarios La Salle
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 22 Nov 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 20 Jul 2022 (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.
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.
Detailed description
Subjects will attend the Neuron rehabilitation clinic or La Beata Hospital on their own to begin a rehabilitation program. After being recruited for the study and signing informed consent an electroencephalography test (EEG) will be performed to determine the absence of ectopic foci and to reduce risks during the treatment process with repetitive transcranial magnetic stimulation (rTMS).
One assessor will be in charge of carrying out the rest of the neurophysiological tests, so the Resting Motor Treshold (RMT) will be collected. To finalise the assessment, a second evaluator will test sensory aspects with the two-point discrimination test, the Semmes-Wenstein monofilaments, the pinprick test and the sterognosia test, and motor aspects by means of the ARAT test.
Once the assessment is completed, the participant will be assigned to the control or experimental group through a randomisation process carried out by another person in the research group using GraphPad software. 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 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.
Participants in the experimental group will receive one hour of rehabilitation therapy daily with 30 minutes of TOT and 30 minutes of RAT, 5 days per week, and 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 stimulation 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).
Finally, once the treatment period is over, after 20 sessions, the assessment will be carried out again, recording the initial tests in the same order by the same assessors.
A descriptive analysis of the demographic characteristics and the main and secondary variables in the sample will be performed, presenting the continuous variables as Mean ± Standard Deviation (SD), 95% Confidence Interval (CI), while the categorical variables will be presented as Number (n) and Percentage (relative frequency, %). To measure normality, the Kolmogorov-Smirnov test will be used, and if the quantitative variables show a non-normal distribution, they will be described with the median and the interquartile range. Parametric tests (normal distribution) will be chosen for comparison between groups based on the central limit theorem, in case the sample exceeds 30 subjects per group. Therefore, the mixed-model ANCOVA test will be used to analyze the group factor in quantitative variables and the chi-square test for qualitative variables to observe the variability of the intra-group treatment response. A P-value < 0.05 will be accepted as statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| repetitive transcranial magnetic stimulation | Experimental | Device: repetitive Transcranial Magnetic StimulationParticipants 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). |
| Sham repetitive transcranial magnetic stimulation | Sham comparator | Device: repetitive Transcranial Magnetic StimulationThe 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| repetitive Transcranial Magnetic StimulationIt 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 | Device | Sham repetitive transcranial magnetic stimulation, repetitive transcranial magnetic stimulation |
Primary outcome
Change in electroencephalographic activity
Time frame: Change from Baseline in electroencephalographic activity at 4 weeks
The electrical signal evoked by the motor cortex when realizing a movement. It will be measured with an electroencephalograph
4 secondary outcomes
Changes in Resting Motor Treshold
Time frame: Change from Baseline in Resting Motor Treshold at 4 weeks
Changes in Motor learning
Time frame: Change from Baseline in Motor learning at 4 weeks
Changes in Sensitivity
Time frame: Change from Baseline in Sensitivity at 4 weeks
Changes in Esterognosia
Time frame: Change from Baseline in esterognosia at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Alfredo Lerín Calvo, PhD student principal investigator
Neuron, Spain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive Transcranial Magnetic Stimulation in people with Transcranial Magnetic Stimulation and Stroke, run by Neuron, Spain at 2 sites 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in electroencephalographic activity (time frame: Change from Baseline in electroencephalographic activity at 4 weeks). 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 20 Mar 2026.