Study of brain and leg muscle characteristics identified using magnetic resonance imaging (MRI) to predict the likelihood of leg function recovery following stroke
| ISRCTN | ISRCTN14822732 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14822732 |
| IRAS number | 249942 |
| Secondary identifying numbers | 8656, IRAS 249942 |
- Submission date
- 12/03/2020
- Registration date
- 22/04/2020
- Last edited
- 10/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
A common consequence of ischaemic stroke is the loss of lower limb function. This can lead to a stoke survivor being unable to continue to live an independent life. It would be beneficial to stroke survivors if clinicians could accurately predict recovery of lower limb function. An accurate prognosis would also enable treatment plans such as the content and duration of rehabilitation to be optimised. However, at present there is a lack of reliable methods for predicting recovery of movement after stroke. Advanced magnetic resonance imaging (MRI) imaging can demonstrate the effect of stroke on the nerve pathways in the brain and the changes in the affected muscles in great detail. Advanced MRI has shown early promise in making recovery predictions in small-scale studies. Our research aims to build on this evidence and answer the question of whether advanced MRI can be used to predict how well stroke survivors will recover lower limb function.
We aim to study 30 participants who have had a first ever ischaemic stroke within the previous four weeks causing different degrees of stroke severity affecting the lower limb. They will undergo MRI brain and lower limb muscle scans lasting 50-60 minutes in a dedicated MRI facility in Newcastle University’s Campus for Ageing and Vitality. A test of physical strength and functional ability of the affected leg lasting about 30mins will be done around the time of the MRI scan and repeated 3 months after stroke. Analysis of our findings will determine whether advanced MRI scan findings are linked to the stroke survivors’ recovery of limb function.
Background and study aims
A common consequence of ischaemic stroke is the loss of lower limb function. This can lead to a stoke survivor being unable to continue to live an independent life. It would be beneficial to stroke survivors if clinicians could accurately predict recovery of lower limb function. An accurate prognosis would also enable treatment plans such as the content and duration of rehabilitation to be optimised. However, at present there is a lack of reliable methods for predicting recovery of movement after stroke. Advanced magnetic resonance imaging (MRI) imaging can demonstrate the effect of stroke on the nerve pathways in the brain and the changes in the affected muscles in great detail. Advanced MRI has shown early promise in making recovery predictions in small-scale studies. This research aims to build on this evidence and answer the question of whether advanced MRI can be used to predict how well stroke survivors will recover. The aim is to study 30 participants who have had a first-ever ischaemic stroke within the previous 4 weeks causing different degrees of stroke severity affecting the lower limb. Analysis of our findings will determine whether advanced MRI scan findings are linked to the stroke survivors’ recovery of limb function.
Who can participate?
Patients aged 18 or over from study centres with first-ever acute ischaemic stroke who meet the eligibility criteria
What does the study involve?
Patients will undergo MRI brain and lower limb muscle scans lasting 50-60 minutes in a dedicated MRI facility in Newcastle University’s Campus for Ageing and Vitality. A test of physical strength and functional ability of the affected leg lasting about 30 minutes will be done around the time of the MRI scan and repeated 3 months after stroke.
What are the possible benefits and risks of participating?
There are no possible benefits or risks associated with participation in the study.
Where is the study run from?
The study is run from Newcastle University and involves hospital sites from Northumbria Healthcare and Newcastle upon Tyne Hospitals NHS Foundation Trusts (UK)
When is the study starting and how long is it expected to run for?
January 2017 to August 2022
Who is funding the study?
NIHR Newcastle Biomedical Research Centre (UK)
Who is the main contact?
Miss Hannah Lumley
Hannah.lumley@newcastle.ac.uk
Contact information
Public
Stroke Research Group
Level 1, Henry Wellcome Building
Faculty of Medical Sciences
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom
 ORCID ID |
0000-0003-1480-0001 |
|---|---|
| Phone | +44 (0)191 208 5847 |
| hannah.lumley@newcastle.ac.uk |
Scientific
Stroke Research Group
Level 1, Henry Wellcome Building
Faculty of Medical Sciences
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom
| ORCID ID |
0000-0003-1480-0001 |
|---|---|
| Phone | +44 (0)191 208 5847 |
| hannah.lumley@newcastle.ac.uk |
Study information
| Study design | Observational longitudinal cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Study In NOvel Neuro-muscular Imaging biomarkers for Motor outcome in Stroke (SINONIMS) |
| Study acronym | SINONIMS |
| Study hypothesis | Hypothesis A: Sarcopenia and loss of motor impairment will be most pronounced in those patients whose ischaemic stroke causes greatest damage to the cortico-spinal (CS) tract and motor pathways as determined by advanced neuroimaging. Hypothesis B: A combination of imaging biomarkers of loss of connectivity in brain and sarcopenia will increase the ability to predict motor outcome in stroke when compared to individual biomarkers alone. |
| Ethics approval(s) |
Approved 05/03/2019, North of Scotland Research Ethics Committee (Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE, United Kingdom; +44 (0)1224558458; nosres@nhs.net), ref: 19/NS/0036 |
| Condition | Acute ischaemic stroke |
| Intervention | 30 acute ischaemic stroke patients with varying degrees of lower limb weakness will undergo advanced magnetic resonance imaging of the brain and thigh muscles, followed by assessments of baseline lower limb motor function (within 4 weeks of onset). A follow-up clinical assessment at 3 months post ictus will then be conducted. The researchers will then examine the relationships between imaging biomarkers and motor outcome in view of developing a predictive model for more accurate prognosis of lower limb motor recovery. This is a small pilot study which is unlikely to result in a robust predictive model; however, it will inform future multicentre studies by exploring feasibility and providing means by which to perform a sample size calculation. In future, this could improve the efficiency of rehabilitation - tailored to the needs of the individual based on their prognosis. |
| Intervention type | Other |
| Primary outcome measure | Lower limb functional impairment measured using the Fugl Meyer Lower Limb Assessment at baseline and 3 months post stroke |
| Secondary outcome measures | Measured at baseline and 3 months post stroke: 1. Leg muscle strength measured using lower limb dynamometry 2. Severity of functional impairment measured using the Lower Limb component of the National Institute of Health Stroke Scale 3. Walking ability measured using the Functional Ambulation Category scale |
| Overall study start date | 01/01/2017 |
| Overall study end date | 31/07/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 47 |
| Participant inclusion criteria | 1. Adults aged 18 or over with first-ever unilateral supra-tentorial ischaemic stroke 2. Unilateral lower limb motor deficit +/- upper limb motor deficit 3. Less than 4 weeks after stroke onset |
| Participant exclusion criteria | 1. Absolute contra-indication to MRI (e.g. pacemaker) 2. Posterior circulation or haemorrhagic stroke (haemorrhagic transformation of ischaemic stroke is not considered as an exclusion criterion) 3. Previous history of anterior circulation stroke (clinically or radiologically) or posterior circulation stroke with residual clinical deficit 4. Lack of capacity to provide informed consent 5. Unable to transfer independently or with assistance of one person if scanned in Newcastle University or with assistance of two people if scanned in Royal Victoria Infirmary 6. Unable to answer MRI safety questionnaire 7. Moderate to high level of dependency prior to stroke (modified Rankin score of >2) 8. Any other pre-existing co-morbidity causing a significant lower limb deficit |
| Recruitment start date | 15/07/2019 |
| Recruitment end date | 01/04/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Cramlington
NE23 6NZ
United Kingdom
Ashington
NE63 9JJ
United Kingdom
Tyne and Wear
North Shields
NE29 8NH
United Kingdom
Newcastle upon Tyne
NE1 4LP
United Kingdom
Sponsor information
Hospital/treatment centre
Newcastle Joint Research Office
Level 1, Regent Point
Regent Farm Road
Gosforth
Newcastle upon Tyne
NE3 3HD
England
United Kingdom
| Phone | +44 (0)191 2824461 |
|---|---|
| nuth.nuthsponsorship@nhs.net | |
| Website | http://www.newcastle-hospitals.org.uk/ |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Government
Private sector organisation / Research institutes and centers
- Alternative name(s)
- Newcastle Biomedical Research Centre, Newcastle NIHR Biomedical Research Centre
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Protocol available on request. The researchers are intending to publish the final results. |
| IPD sharing plan | The researchers are planning to store raw imaging data (T1; T2; DWI and DTI of brain, T1; STIR; MR Spectroscopy and 3-point Dixon of thigh muscles) alongside the clinical assessment data in the ENIGMA consortium (http://enigma.ini.usc.edu/about-2/). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.4 | 18/05/2021 | 25/07/2023 | No | No |
| HRA research summary | 26/07/2023 | No | No | ||
| Results article | 24/10/2023 | 10/11/2023 | Yes | No |
Additional files
Editorial Notes
10/11/2023: Publication reference added.
25/07/2023: The following changes were made:
1. Uploaded protocol (not peer reviewed).
2. The overall study end date has been changed from 31/08/2022 to 31/08/2022 and the plain English summary has been updated accordingly.
3. The total final enrolment was added.
4. The recruitment end date was changed from 31/05/2021 to 01/04/2022.
5. The intention to publish date was changed from 31/08/2022 to 31/07/2023.
12/10/2021: The intention to publish date was changed from 31/10/2021 to 31/08/2022.
12/08/2021: The overall trial end date has been changed from 31/10/2021 to 31/08/2022 and the plain English summary has been updated accordingly.
23/02/2021: Internal review.
16/03/2020: Trial's existence confirmed by North of Scotland Research Ethics Committee.
