Condition category
Circulatory System
Date applied
12/03/2020
Date assigned
22/04/2020
Last edited
22/04/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 October 2021

Who is funding the study?
NIHR Newcastle Biomedical Research Centre (UK)

Who is the main contact?
Miss Hannah Lumley
Hannah.lumley@newcastle.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Miss Hannah Lumley

ORCID ID

https://orcid.org/0000-0003-1480-0001

Contact details

Stroke Research Group
Level 1
Henry Wellcome Building
Faculty of Medical Sciences
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom
+44 (0)191 208 5847
hannah.lumley@newcastle.ac.uk

Type

Scientific

Additional contact

Miss Hannah Lumley

ORCID ID

https://orcid.org/0000-0003-1480-0001

Contact details

Stroke Research Group
Level 1
Henry Wellcome Building
Faculty of Medical Sciences
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom
+44 (0)191 208 5847
hannah.lumley@newcastle.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

8656, IRAS 249942

Study information

Scientific title

Study In NOvel Neuro-muscular Imaging biomarkers for Motor outcome in Stroke (SINONIMS)

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

Approved 05/03/2019, North of Scotland Research Ethics Committee (Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE, UK; Telephone: +44 (0)1224558458; Email: nosres@nhs.net), REC ref: 19/NS/0036

Study design

Observational longitudinal cohort study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

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

Phase

Drug names

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 trial start date

01/01/2017

Overall trial end date

31/10/2021

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

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

31/05/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Northumbria Specialist Emergency Care Hospital
Northumbria Way
Cramlington
NE23 6NZ
United Kingdom

Trial participating centre

Wansbeck General Hospital
Woodhorn Lane
Ashington
NE63 9JJ
United Kingdom

Trial participating centre

North Tyneside General Hospital
Rake Lane Tyne and Wear
North Shields
NE29 8NH
United Kingdom

Trial participating centre

Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust

Sponsor details

Newcastle Joint Research Office
Level 1
Regent Point
Regent Farm Road
Gosforth
Newcastle upon Tyne
NE3 3HD
United Kingdom
+44 (0)191 2824461
nuth.nuthsponsorship@nhs.net

Sponsor type

Hospital/treatment centre

Website

http://www.newcastle-hospitals.org.uk/

Funders

Funder type

Government

Funder name

NIHR Newcastle Biomedical Research Centre

Alternative name(s)

Newcastle NIHR Biomedical Research Centre, Newcastle Biomedical Research Centre

Funding Body Type

private sector organisation

Funding Body Subtype

Research institutes and centers

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Protocol available on request. The researchers are intending to publish the final results.

IPD sharing statement
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/).

Intention to publish date

31/10/2021

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

16/03/2020: Trial's existence confirmed by North of Scotland Research Ethics Committee.