Ischemic Stroke
Conditions
Brief summary
The investigator aims to find a correlation between brain structure and activity and spontaneous recovery of motor function following brain ischemic stroke by Analysis of MRI scans. The research includes stroke patients and healthy patients (control group).
Detailed description
The recovery process, especially the recovery of motor functions after an ischemic stroke, differs from one person to another. In recent years, there is more evidence of spontaneous biological recovery (SBR), which is independent of training or rehabilitation-induced recovery, throughout the post-stroke subacute phase. However, the neural basis associated with motor function in this recovery phase remains unknown. We believe that the research results may help to explain the neural mechanism which promotes or inhibits recovery.
Interventions
DIAGNOSTIC_TESTMRI scans
The MRI protocol will include standard anatomical, functional, and diffusion imaging, and spectroscopy sequences.
BEHAVIORALclinical assessments
Several clinical assessments will be performed to evaluate the recovery of motor functions. Initially and for screening, the cognitive ability will be assessed using the Montreal Cognitive Assessment (MoCA), and visuospatial neglect will be assessed using the Star Cancellation Test (SCT). eligible participants that meet all inclusion criteria will undergo a series of clinical function tests during each test session (t1-t4) to assess clinical outcomes.
Sponsors
Sheba Medical Center
Technion, Israel Institute of Technology
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. age between 21 years old and 80 years old 2. admission to the hospital 2-14 days after a first ischemic stroke, confirmed by CT, MRI or neurological report 3. residual unilateral upper extremity weakness 4. ability to give informed consent and understand the tasks involved.
Exclusion criteria
1. younger than 21 years old or older than 80 years old 2. cognitive impairment, as seen by a score of \<20/30 on the Montreal Cognitive Assessment (MoCA) 3. history of a physical or neurological condition that interferes with study procedures or assessment of motor function (e.g. severe arthritis, severe neuropathy, Parkinson's disease) 4. contraindication to transcranial magnetic stimulation (TMS), such as deep brain stimulators or skull defect, presence of other metal devices or objects in the head, or a pacemaker 5. inability to sit in a chair and perform upper limb exercises for one hour at a time 6. inability to lie down in the MRI scanner for an hour 7. participation in another upper extremity rehabilitative therapy study during the study period 8. terminal illness 9. social and/or personal circumstances that interfere with the ability to return for therapy sessions and follow-up assessments 10. pregnancy 11. severe visuospatial neglect, as seen by a score of \<44/54 on the Star Cancellation Test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurochemical concentration levels as revealed by MRS scans. Including GABA, Glu and GSH. | Baseline GABA/ GLU/ GSH at <=2 weeks from stroke event (t1), change from Baseline GABA/ GLU/ GSH at 4 weeks (t2), change from Baseline GABA/ GLU/ GSH at 8 weeks (t3), change from Baseline GABA/ GLU/ GSH at 12 weeks (t4) | — |
| Clinical measures- Arm Research Action Test (ARAT) | Baseline ARAT at <=2 weeks from stroke event (t1), change from Baseline ARAT at 4 weeks (t2), change from Baseline ARAT at 8 weeks (t3), change from Baseline ARAT at 12 weeks (t4) | The patient is seated at a table and is asked to perform tasks involving handling physical objects, on the table, with different properties (size, weight, shape, etc.). |
| Clinical measures- Fugl-Meyer Upper Extremity (FM-UE) | Baseline FM_UE at <=2 weeks from stroke event (t1), change from Baseline FM_UE at 4 weeks (t2), change from Baseline FM_UE at 8 weeks (t3), change from Baseline FM_UE at 12 weeks (t4) | FM-UE- Administrator instructs patient to perform a series of physical tasks, also involves passive eliciting of reflexes for assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Ashworth Scale (MAS) | Baseline MAS at <=2 weeks from stroke event (t1), change from Baseline MAS at 4 weeks (t2), change from Baseline MAS at 8 weeks (t3), change from Baseline MAS at 12 weeks (t4) | Relevant limbs are passively manipulated through various degrees of range of motion while making observations of muscle tone. |
| Semmes-Weinstein Monofilament Examination (SWME) | Baseline SWME at <=2 weeks from stroke event (t1), change from Baseline SWME at 4 weeks (t2), change from Baseline SWME at 8 weeks (t3), change from Baseline SWME at 12 weeks (t4) | Nylon filaments of different diameters are applied perpendicularly to the palmar surface of the index finger until the filament bends. The threshold is determined by the smallest diameter that is perceived. |
Countries
Israel
Contacts
Primary ContactFiras Mawase, Prof.
Backup ContactGabriel Zeilig, Prof
Outcome results
None listed