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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05889429
• Other study ID #: MOH_2020-06-24_009069
• Status: Recruiting
• Start date: January 26, 2021
• Est. completion date: January 2025

Study information

• Verified date: May 2023
• Source: Technion, Israel Institute of Technology
• Contact: Firas Mawase, Prof.
• Phone: +972-77-887-4127
• Email: mawasef[@]bm.technion.ac.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Diagnostic Test:
• MRI scans
The MRI protocol will include standard anatomical, functional, and diffusion imaging, and spectroscopy sequences.

Behavioral:
• clinical 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.

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (2)

Lead Sponsor	Collaborator
Technion, Israel Institute of Technology	Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Modified Ashworth Scale (MAS)	Relevant limbs are passively manipulated through various degrees of range of motion while making observations of muscle tone.	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)
Secondary	Semmes-Weinstein Monofilament Examination (SWME)	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.	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)