Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-29 @ 12:54 PM
Study NCT ID:
NCT05467657
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2021-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Magnetic Stimulation on Somtosensory Cortex Enhances Motor Learning in People With Stroke
Sponsor:
Neuron, Spain
Organization:
Study Overview
Official Title:
Efficacy of Repetitive Transcranial Magnetic Stimulation of the Somatosensory Cortex on Motor Learning
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 ANOVA 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. In case ANOVA reveals statistical significance, a post-hoc analysis with Bonferroni correction will be performed. A P-value \< 0.05 will be accepted as statistically significant.
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 ANOVA 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. In case ANOVA reveals statistical significance, a post-hoc analysis with Bonferroni correction will be performed. A P-value \< 0.05 will be accepted as statistically significant.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: