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

Primary Purpose

Transcranial Magnetic Stimulation, Stroke, Motor Learning

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
repetitive Transcranial Magnetic Stimulation
Sponsored by
Neuron, Spain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transcranial Magnetic Stimulation focused on measuring Transcranial magnetic stimulation, Stroke, Motor learning, Somatosensory cortex, Motor function

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Having suffered an ischaemic or haemorrhagic stroke with less than 6 months of evolution
  • Presenting a score >21 points on the Mini-mental State Examination scale.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Neuron Chamberí

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

repetitive transcranial magnetic stimulation

Sham repetitive transcranial magnetic stimulation

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Changes in Electromyographic activity in flexor and extensor muscles
Using a high-density electromyograph placed on the dorsal and palmar aspect of the forearm, the patient is asked to perform a maximal contraction of the flexor and extensor muscles of the wrist and fingers. In this way, the motor recruitment capacity present in the patient is recorded by the number of motor units that are recruited during a maximal activation.
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)
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
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.

Full Information

First Posted
October 4, 2021
Last Updated
March 27, 2023
Sponsor
Neuron, Spain
Collaborators
Universidad Autonoma de Madrid, Hospital Beata María Ana
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1. Study Identification

Unique Protocol Identification Number
NCT05467657
Brief Title
Transcranial Magnetic Stimulation on Somtosensory Cortex Enhances Motor Learning in People With Stroke
Official Title
Efficacy of Repetitive Transcranial Magnetic Stimulation of the Somatosensory Cortex on Motor Learning
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 15, 2023 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Neuron, Spain
Collaborators
Universidad Autonoma de Madrid, Hospital Beata María Ana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 motor and sensory evoked potential will be collected, and a high-density electromyography (EMG) will be performed on the flexor and extensor muscles of the forearm. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transcranial Magnetic Stimulation, Stroke, Motor Learning
Keywords
Transcranial magnetic stimulation, Stroke, Motor learning, Somatosensory cortex, Motor function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
repetitive transcranial magnetic stimulation
Arm Type
Experimental
Arm Description
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).
Arm Title
Sham repetitive transcranial magnetic stimulation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
repetitive Transcranial Magnetic Stimulation
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in electroencephalographic activity
Description
The electrical signal evoked by the motor cortex when realizing a movement. It will be measured with an electroencephalograph
Time Frame
Change from Baseline in electroencephalographic activity at 4 weeks
Secondary Outcome Measure Information:
Title
Changes in Resting Motor Treshold
Description
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.
Time Frame
Change from Baseline in Resting Motor Treshold at 4 weeks
Title
Changes in Electromyographic activity in flexor and extensor muscles
Description
Using a high-density electromyograph placed on the dorsal and palmar aspect of the forearm, the patient is asked to perform a maximal contraction of the flexor and extensor muscles of the wrist and fingers. In this way, the motor recruitment capacity present in the patient is recorded by the number of motor units that are recruited during a maximal activation.
Time Frame
Change from Baseline in Electromyographic activity in flexor and extensor muscles at 4 weeks
Title
Changes in Motor learning
Description
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)
Time Frame
Change from Baseline in Motor learning at 4 weeks
Title
Changes in Sensitivity
Description
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
Time Frame
Change from Baseline in Sensitivity at 4 weeks
Title
Changes in Esterognosia
Description
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.
Time Frame
Change from Baseline in esterognosia at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having suffered an ischaemic or haemorrhagic stroke with less than 6 months of evolution Presenting a score >21 points on the Mini-mental State Examination scale. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alfredo Lerín Calvo, PhD student
Phone
620187457
Email
alfre_lerin@hotmail.com
Facility Information:
Facility Name
Neuron Chamberí
City
Madrid
ZIP/Postal Code
28003
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfredo Lerín, PhD student
Phone
620187457
Email
alfre_lerin@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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