Non-invasive Neuromodulation Guided Through Biomarkers in Patients With Stroke Sequels
NCT ID: NCT04816305
Last Updated: 2023-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2021-03-29
2024-06-30
Brief Summary
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Detailed Description
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All patients and volunteers will be assigned to groups (arms) after being tried:
(i) rTMS-DIR: in which the patients will be submitted to a customized treatment with repetitive transcranial magnetic stimulation (rTMS) based in neurophysiological assessments; (ii) rTMS: patients will be submitted to standard treatment in the lesioned or non-lesioned hemisphere based in neurophysiological assessments; (iii) rTMS sham: each patient will receive a sham intervention that emits the same sound as the real stimulation;
In each group, the patients will be submitted to 10 sessions for two weeks, five days a week in which will receive the rTMS followed by 45 minutes of neurofunctional physiotherapy. All outcomes will be assessed before and after the 10 sessions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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rTMSc + physiotherapy
A conventional high-frequency rTMS (rTMSc) will be applied over the lesioned hemisphere over the motor cortex. After rTMSc, patients will be submitted to 45 minutes of neurofunctional physiotherapy. Experimental sessions will be repeated five times per week for two weeks.
rTMSc
In all rTMS protocols the patient will remain seated in a comfortable chair with adjustable arms and head rests. Before the start of the conventional rTMS (rTMSc), the resting motor threshold (RMT) of the first dorsal interosseous muscle contralateral to the lesioned hemisphere will be determined. The RMT will be defined as the lowest RMT intensity necessary to produce a motor evoked potential amplitude greater than or equal to 50 µV in at least 5 out of 10 attempts.
Neurofunctional physiotherapy
All patients will be submitted to a protocol of exercise with different levels according to motor learning, neuroplasticity principles and motor impairment. All physiotherapists will be trained prior to the study.
rTMSp + physiotherapy
A personalized high or low-frequency rTMS (rTMSp) will be applied to the lesioned or non-lesioned hemisphere depending on cortical biomarkers assessment guide a personalized stimulation for each patient in this group. After rTMSp, patients will be submitted to 45 minutes of neurofunctional physiotherapy. Experimental sessions will be repeated five times per week for two weeks.
rTMSc
In all rTMS protocols the patient will remain seated in a comfortable chair with adjustable arms and head rests. Before the start of the conventional rTMS (rTMSc), the resting motor threshold (RMT) of the first dorsal interosseous muscle contralateral to the lesioned hemisphere will be determined. The RMT will be defined as the lowest RMT intensity necessary to produce a motor evoked potential amplitude greater than or equal to 50 µV in at least 5 out of 10 attempts.
Neurofunctional physiotherapy
All patients will be submitted to a protocol of exercise with different levels according to motor learning, neuroplasticity principles and motor impairment. All physiotherapists will be trained prior to the study.
tDCS sham + physiotherapy
The sham protocol will be delivered to each patient of this arm imitating the exat sound of the equipment and structure of the experimental arms. After rTMS sham, patients will be submitted to 45 minutes of neurofunctional physiotherapy. Experimental sessions will be repeated five times per week for two weeks.
Neurofunctional physiotherapy
All patients will be submitted to a protocol of exercise with different levels according to motor learning, neuroplasticity principles and motor impairment. All physiotherapists will be trained prior to the study.
rTMS sham
During the rTMS sham sessions the same procedures will be used as the rTMSc protocols, however, the magnetic stimulator and its coil will be turned off.
Interventions
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rTMSc
In all rTMS protocols the patient will remain seated in a comfortable chair with adjustable arms and head rests. Before the start of the conventional rTMS (rTMSc), the resting motor threshold (RMT) of the first dorsal interosseous muscle contralateral to the lesioned hemisphere will be determined. The RMT will be defined as the lowest RMT intensity necessary to produce a motor evoked potential amplitude greater than or equal to 50 µV in at least 5 out of 10 attempts.
Neurofunctional physiotherapy
All patients will be submitted to a protocol of exercise with different levels according to motor learning, neuroplasticity principles and motor impairment. All physiotherapists will be trained prior to the study.
rTMS sham
During the rTMS sham sessions the same procedures will be used as the rTMSc protocols, however, the magnetic stimulator and its coil will be turned off.
Eligibility Criteria
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Inclusion Criteria
* Ischemic or hemorrhagic stroke with upper limb motor impairment;
Exclusion Criteria
* Peripheral lesions in the assessed upper limb;
* Score ≤ 18 at Folstein Mini Mental State Examination;
* Alteration of drugs that alter the excitability of the cortex (in less than 3 months);
* Application of botulinum toxin in less than 6 months.
18 Years
75 Years
ALL
No
Sponsors
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Universidade Federal de Pernambuco
OTHER
Responsible Party
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Kátia Monte-Silva
Clinical professor
Locations
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Federal University of Pernambucano
Recife, Pernambuco, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TMS_biomarkers_stroke
Identifier Type: -
Identifier Source: org_study_id
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