Intracerebral haemorrhage Stroke, not specified as haemorrhage or infarction
Conditions
Interventions
This is a five-arm randomized controlled double-blind clinical trial involving 250 participants, including 125 healthy individuals and 125 patients with chronic Stroke. Participants will be distribute
Sponsors
Universidade de São Paulo
Universidade de São Paulo
Eligibility
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: Individuals of both sexes; aged between 30 and 75 years; diagnosis of left ischemic stroke confirmed by computed tomography or magnetic resonance imaging; between 3 weeks and 1 year post stroke; right upper limb motor preference assessed by the Edinburgh Handedness Inventory translated and validated into Portuguese with inclusion of only right handed participants with right hemiparesis and preserved right handgrip function; minimum score of 50% in the upper limb domain (27/54) of the Fugl-Meyer Assessment scale
Exclusion criteria
Exclusion criteria: Left motor preference assessed using the Edinburgh Handedness Inventory; orthopedic disorders; contraindications to repetitive transcranial magnetic stimulation, including a personal or first-degree family history of epilepsy or seizure disorders; presence of metallic implants or active electronic devices in the head or neck region; presence of a cardiac pacemaker or implanted defibrillator; inability to understand written and spoken Portuguese; pain during task performance; difficulty performing handgrip or index finger flexion movements; failure to achieve at least 70 percent of the Maximum Voluntary Isometric Contraction (MVIC)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to identify changes in corticospinal excitability, verified through transcranial magnetic stimulation by measuring peak-to-peak motor evoked potential amplitude in the first dorsal interosseous muscle before and after the intervention. Changes will be observed by analyzing absolute values and percentage variation between pre- and post-intervention assessments;It is expected to identify changes in motor overflow, verified through transcranial magnetic stimulation using the motor overflow index based on motor evoked potentials. The outcome will be determined by percentage variation between resting and motor task conditions before and after the intervention;It is expected to identify changes in force irradiation, verified through handgrip dynamometry during standardized isometric contractions. The outcome will be determined by changes in force irradiation indices obtained before and after the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to identify changes in handgrip strength, verified through dynamometry. The outcome will be determined by percentage values of maximum voluntary isometric contraction obtained before and after the intervention;It is expected to identify differences in neurophysiological and mechanical responses between healthy individuals and patients with stroke, verified through motor evoked potentials and handgrip dynamometry. Differences will be determined through intergroup comparisons of neurophysiological and mechanical parameters;It is expected to identify differences between stimulation areas, verified through transcranial magnetic stimulation. Differences will be determined through comparisons between the primary motor cortex, supplementary motor area, and anterior cingulate cortex regarding neurophysiological and mechanical parameters;It is expected to identify the influence of time on neurophysiological and mechanical outcomes, verified through pre- and post-intervention assessments. The effect will be determined by changes observed between evaluation moments;It is expected to identify the influence of laterality on neurophysiological and mechanical outcomes, verified through neurophysiological assessment and dynamometry. The effect will be determined by differences observed between body sides;It is expected to identify changes in motor evoked potential latency, verified through transcranial magnetic stimulation before and after the intervention. Changes will be observed through absolute values and percentage variation;It is expected to identify changes in motor evoked potential duration, verified through transcranial magnetic stimulation before and after the intervention. Changes will be observed through absolute values and percentage variation | — |
Countries
BR
Contacts
Public ContactJoão Araújo
Universidade de São Paulo
Outcome results
None listed