Stroke Clinical Trial
Official title:
Project NEUROMOD: Non-invasive Neuromodulation Guided Through Biomarkers in Patients With Stroke Sequels
This study aims to investigate if the size effect of repetitive magnetic transcranial stimulation in the paretic upper limb in patients after stroke is influenced by the therapeutic decision.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 30, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - More than 3 months after stroke; - Ischemic or hemorrhagic stroke with upper limb motor impairment; Exclusion Criteria: - Any contraindication for application of transcranial magnetic stimulation; - 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Federal University of Pernambucano | Recife | Pernambuco |
Lead Sponsor | Collaborator |
---|---|
Universidade Federal de Pernambuco |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Brain symmetry (baseline) | Accessed with: Quantitative electroencephalogram (qEEG) through the power spectral density (PSD) for each channel considering each band frequency: delta (0,5 a = 4 Hz); theta (> 4 a = 8 Hz); alpha (> 8 a =13 Hz); beta (> 13 a = 30 Hz); gama (< 30 a = 45 Hz) and the relative power for each band. . The Brain Symmetry Index (BSI) will be used to assess the absolute value of the difference in mean hemispheric power in the frequency range of 1 to 45Hz. All of these measures derive from each qEEG band frequency. |
Before each session (10 sessions for 5 days a week for two weeks) | |
Primary | Brain symmetry (post-treatment) | Accessed with: Quantitative electroencephalogram (qEEG) through the power spectral density (PSD) for each channel considering each band frequency: delta (0,5 a = 4 Hz); theta (> 4 a = 8 Hz); alpha (> 8 a =13 Hz); beta (> 13 a = 30 Hz); gama (< 30 a = 45 Hz) and the relative power for each band. . The Brain Symmetry Index (BSI) will be used to assess the absolute value of the difference in mean hemispheric power in the frequency range of 1 to 45Hz. All of these measures derive from each qEEG band frequency. |
After each session (10 sessions for 5 days a week for two weeks) | |
Primary | Brain symmetry (baseline) | Accessed with: Low-Resolution Brain Electromagnetic Tomography (LORETA) software. All data from qEEG will also be computed to the LORETA software to generate a tridimensional image of the patient's brain. |
Before each session (10 sessions for 5 days a week for two weeks) | |
Primary | Brain symmetry (post-treatment) | Accessed with: Low-Resolution Brain Electromagnetic Tomography (LORETA) software. All data from qEEG will also be computed to the LORETA software to generate a tridimensional image of the patient's brain. |
After each session (10 sessions for 5 days a week for two weeks) | |
Secondary | Change in Fugl Meyer assesment of paretic upper limb motor function | Fugl Meyer assesment is used to measure motor control recovery. It is a 226 point scoring system that includes the following sessions: range of motion, pain, sensation,motor function of upper and lower limbs, balance, coordination and velocity. We will apply only two sessions: upper limb motor function and coordination/velocity, these sessions totalize 66 points. Higher scores indicates better outcomes | 10 sessions (5 days a week for two weeks) | |
Secondary | Modified Ashworth Scale | The modified Ashworth scale is a 6-point rating scale that is used to measure muscle tone and it will be used to determine the spasticity wrist flexor muscles in the affected hand by stroke. It evaluates the antagonist muscles that limits the force of agonist muscled during a intended motion. | 10 sessions (5 days a week for two weeks) | |
Secondary | The National Institutes of Health Stroke | This scale will determine the severity and disability level of the post-stroke patient; which consists of 15 items that assess the domains: level of consciousness, eye movements, visual field, facial movements, motor function and ataxia of upper and lower limbs, as well as sensitivity, language, presence of dysarthria and spatial neglect. Each domain punctuates a specific skill from 0 (zero) to 4 points that may vary until a maximum of 42 points. | 10 sessions (5 days a week for two weeks) |
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