Cerebral venous drainage in multiple sclerosis
| ISRCTN | ISRCTN75786983 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75786983 |
| Secondary identifying numbers | 11/LO/1139 |
- Submission date
- 17/10/2011
- Registration date
- 14/11/2011
- Last edited
- 27/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Multiple sclerosis is a disease of unknown origin causing disability in young adults. Recently differences in the blood flow in the neck veins have been described in multiple sclerosis. These can be found using a simple ultrasound scan that is safe and acceptable to most patients. The aims of this study are: to establish how common these findings are in a sample of UK multiple sclerosis patients; to establish if these findings are more common in multiple sclerosis patients than people without multiple sclerosis (called controls); to establish how variable ultrasound is in identifying these findings.
Who can participate?
30 patients of any gender over 18 years of age with any pattern of multiple sclerosis with an estimated disease severity score (EDSS) of 6 or less. 30 healthy controls with the same age and gender will also be tested.
What does the study involve?
The study will involve an initial examination by a neurologist to ensure that individuals are suitable to participate. There will then be a one hour ultrasound examination of the neck veins sitting and lying flat. This will be repeated after thirty minutes by a second sonographer.
All participants will be invited back for a second scan by one of the same sonographers.
What are the possible benefits and risks of participating?
Participants will not gain any direct benefit from participating. There are no side-effects.
Where is the study run from?
Imperial College London (UK).
When is the study starting and how long is it expected to run for?
The study will commence in November 2011 and recruit for 1 year, with results expected in early 2013.
Who is funding the study?
Royal College of Surgeons of England, the Circulation Foundation and the Venous Forum at the Royal Society of Medicine (UK).
Who is the main contact?
Dr Richard Nicholas
nicholas@imperial.ac.uk
Contact information
Scientific
MS Day Unit
4 North
Charing Cross Hospital
London
W6 8RF
United Kingdom
Study information
| Study design | Sonographer blinded age-sex healthy control matched cross-sectional ultrasound study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Cerebral venous drainage in multiple sclerosis: protocol for a blinded, age-sex matched cross-sectional ultrasound study |
| Study objectives | There will be statistically and clinically significant differences in cerebral venous outflow disturbance between multiple sclerosis patients and healthy controls. |
| Ethics approval(s) | UK National Research Ethics Board, 15/08/2011, ref: 11/LO/1139 |
| Health condition(s) or problem(s) studied | Multiple sclerosis |
| Intervention | All participants will undergo a lying and standing blood pressure measurement and an electrocardiogram (heart tracing) on entry to the study. All participants will then undergo a one hour ultrasound examination of the neck, comprising thirty minutes lying flat and thirty minutes sitting upright. At the end of the examination the images will be stored for future analysis at a another time point, i.e. results will not be disclosed to the participant. Any willing participants will be invited back for a future rescan in 2 weeks by one of the same sonographers. No further follow up is required for this study. |
| Intervention type | Other |
| Primary outcome measure | 1. Reflux (>0.88s) in the internal jugular (IJV) and vertebral veins (VVs) using triplex mode 2. High resolution B-mode evidence of IJV stenosis in transverse orientation (>50% cross-sectional area diameter reduction) with and without Valsalva 3. Undetectable Doppler flow in the IJVs and VVs using colour and Spectral Doppler 4. Cross-sectional area change of the IJV from the supine to sitting position |
| Secondary outcome measures | Inter and intra sonographer reproducibility |
| Overall study start date | 01/11/2011 |
| Completion date | 01/11/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. 18 years of age or greater 2. Informed consent 3. Cases: multiple sclerosis by McDonald criteria with estimated disease severity score < 6, any disease pattern 4. Controls: no other relevant health condition 5. Ability to perform Valsalva manoeuvre 6. Stable disease for one month pre-recruitment |
| Key exclusion criteria | 1. Concurrent enrolment in multiple sclerosis drug trial 2. Concurrent masking neurological disease 3. Pregnancy 4. Inability to lie supine 5. Intercurrent infection 6. Superior vena cava obstruction 7. Tricuspid regurgitation 8. Right heart failure 9. Vasculitis 10. Treatment with venodilators (e.g. nitrates) 11. Head and neck surgery or radiotherapy 12. Previous central venous catheterisation 13. Previous central venous thrombosis 14. Thrombophilia 15. Arrhythmia on baseline electrocardiogram (ECG) 16. Postural systolic drop of >30mmHg on standing 17. Steroid treatment within one month 18. Pulmonary hypertension 19. Malignancy |
| Date of first enrolment | 01/11/2011 |
| Date of final enrolment | 01/11/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
4 North
London
W6 8RF
United Kingdom
Sponsor information
University/education
Joint Research Office
Exhibition Road
London
SW7 2AZ
England
United Kingdom
"ROR" |
https://ror.org/041kmwe10 |
|---|
Funders
Funder type
University/education
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
27/04/2018: No publications found, verifying study status with principal investigator.
18/03/2016: No publications found, verifying study status with principal investigator.
