Ischemic StrokeNCT05889429
Correlation Between Brain Structure and Activity and Spontaneous Recovery of Motor Function Following Brain Ischemic Stroke
An observational study of Ischemic Stroke, run by Technion, Israel Institute of Technology at 1 site in Israel.
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). Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- MRI scans and clinical assessments
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 26 Jan 2021to Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Gabriel Zeilig, Prof contact
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Gabirel Zeilig, Prof, gabi.zeilig@sheba.health.gov.il
About this study
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).
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- MRI scans, clinical assessments
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scansDiagnostic test
The MRI protocol will include standard anatomical, functional, and diffusion imaging, and spectroscopy sequences.
clinical assessmentsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Diagnostic Test: MRI scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurochemical concentration levels as revealed by MRS scans. Including GABA, Glu and GSH.
Measured: 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.).
Measured: 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.
Measured: 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)
Relevant limbs are passively manipulated through various degrees of range of motion while making observations of muscle tone.
Measured: 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)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start26 Jan 2021
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technion, Israel Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Sheba Medical Center
- Responsible party
- Principal investigator, Firas Mawase, Technion, Israel Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889429
- Sponsor's protocol ID
- MOH_2020-06-24_009069
- Status last verified
- May 2023
- First submitted
- 9 May 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Brain Structure and Activity and Spontaneous Recovery of Motor Function Following Brain Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05889429
- Acronym / sponsor ID
- MOH_2020-06-24_009069
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Technion, Israel Institute of TechnologyUniversity, hospital or other
- Collaborators
- Sheba Medical Center
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| brain ischemic stroke patients | – | Diagnostic Test: MRI scans, Behavioral: clinical assessmentsParticipants 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 |
| Control group | – | Diagnostic Test: MRI scansParticipants 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scansThe MRI protocol will include standard anatomical, functional, and diffusion imaging, and spectroscopy sequences. | Diagnostic test | Control group, brain ischemic stroke patients |
| clinical assessmentsSeveral 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. | Behavioural | brain ischemic stroke patients |
Primary outcome
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.
2 secondary outcomes
Modified Ashworth Scale (MAS)
Time frame: 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)
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel Zeilig, Prof contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Technion, Israel Institute of Technology at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Firas Mawase, Prof. (+972-77-887-4127, mawasef@bm.technion.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023; AzTrials last refreshed its copy on 1 Nov 2026.