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Clinical Trials/NCT05889429
NCT05889429
Recruiting
Not Applicable

Correlation Between Brain Structure and Activity and Spontaneous Recovery of Motor Function Following Brain Ischemic Stroke

Technion, Israel Institute of Technology1 site in 1 country60 target enrollmentJanuary 26, 2021
ConditionsIschemic Stroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ischemic Stroke
Sponsor
Technion, Israel Institute of Technology
Enrollment
60
Locations
1
Primary Endpoint
Neurochemical concentration levels as revealed by MRS scans. Including GABA, Glu and GSH.
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 26, 2021
End Date
January 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Firas Mawase

Prof. Firas Mawase

Technion, Israel Institute of Technology

Eligibility Criteria

Inclusion Criteria

  • age between 21 years old and 80 years old
  • admission to the hospital 2-14 days after a first ischemic stroke, confirmed by CT, MRI or neurological report
  • residual unilateral upper extremity weakness
  • ability to give informed consent and understand the tasks involved.

Exclusion Criteria

  • younger than 21 years old or older than 80 years old
  • cognitive impairment, as seen by a score of \<20/30 on the Montreal Cognitive Assessment (MoCA)
  • 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)
  • 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
  • inability to sit in a chair and perform upper limb exercises for one hour at a time
  • inability to lie down in the MRI scanner for an hour
  • participation in another upper extremity rehabilitative therapy study during the study period
  • terminal illness
  • social and/or personal circumstances that interfere with the ability to return for therapy sessions and follow-up assessments
  • severe visuospatial neglect, as seen by a score of \<44/54 on the Star Cancellation Test.

Outcomes

Primary Outcomes

Neurochemical concentration levels as revealed by MRS scans. Including GABA, Glu and GSH.

Time Frame: 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)

Time Frame: 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)

Time Frame: 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 Outcomes

  • 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))
  • 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))

Study Sites (1)

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