Condition category
Nervous System Diseases
Date applied
17/10/2011
Date assigned
14/11/2011
Last edited
18/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richard Nicholas

ORCID ID

Contact details

MS Day Unit
4 North
Charing Cross Hospital
London
W6 8RF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11/LO/1139

Study information

Scientific title

Cerebral venous drainage in multiple sclerosis: protocol for a blinded, age-sex matched cross-sectional ultrasound study

Acronym

Study hypothesis

There will be statistically and clinically significant differences in cerebral venous outflow disturbance between multiple sclerosis patients and healthy controls.

Ethics approval

UK National Research Ethics Board approved on 15th August 2011, ref: 11/LO/1139

Study design

Sonographer blinded age-sex healthy control matched cross-sectional ultrasound study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/11/2011

Overall trial end date

01/11/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

01/11/2011

Recruitment end date

01/11/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Charing Cross Hospital
MS Day Unit 4 North
London
W6 8RF
United Kingdom

Sponsor information

Organisation

Imperial College London

Sponsor details

Joint Research Office
Exhibition Road
London
SW7 2AZ
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

The Royal College of Surgeons of England

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Venous Forum at the Royal Society of Medicine

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/03/2016: No publications found, verifying study status with principal investigator