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

NCT05889429 | Unknown

• 1 other identifier: MOH_2020-06-24_009069
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (3)

• 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)

  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.).

  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)

• Clinical measures- Fugl-Meyer Upper Extremity (FM-UE)

  FM-UE- Administrator instructs patient to perform a series of physical tasks, also involves passive eliciting of reflexes for assessment.

  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)

Secondary Outcomes (2)

• 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 Arms (2)

brain ischemic stroke patients

Participants who meet the inclusion criteria. All participants will undergo four testing sessions spanning the acute and subacute post-stroke phases: Session 1 (t1) - 2-14 days from stroke onset Session 2 (t2) - 4 weeks (± 7 days) after the stroke Session 3 (t3) - 8 weeks (± 7 days) after the stroke Session 4 (t4) - 12 weeks (± 7 days) after the stroke

Diagnostic Test: MRI scans; Behavioral: clinical assessments

Control group

Participants with healthy age and gender-matched with no history of neurological impairments. Each participant will visit the testing sites 4 times within one month between different sessions.

Diagnostic Test: MRI scans

Interventions

MRI scans DIAGNOSTIC_TEST

The MRI protocol will include standard anatomical, functional, and diffusion imaging, and spectroscopy sequences.

Control group; brain ischemic stroke patients

clinical assessments BEHAVIORAL

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.

brain ischemic stroke patients

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Thirty stroke patients (experimental group) will be recruited from Sheba Medical Center, and 30 healthy age and gender-matched participants (control group) with no history of neurological impairments will be recruited from the community for participation in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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
• pregnancy
• severe visuospatial neglect, as seen by a score of \<44/54 on the Star Cancellation Test.

Sponsors & Collaborators

• Technion, Israel Institute of Technology: lead
• Sheba Medical Center: collaborator

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Firas Mawase, Prof.

CONTACT

+972-77-887-4127; mawasef@bm.technion.ac.il

Gabriel Zeilig, Prof

CONTACT

gabi.zeilig@sheba.health.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Firas Mawase

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: June 5, 2023
• Study Start: January 26, 2021
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: June 5, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)