The main point of this study is to detect in a controlled fashion if there is a relationship between CCSVI and MS. We focus on 5 parameters indicative of CCSVI: 1-reflux in the internal jugular vein (IJV) or in the vertebral vein (VV), or both with…
ID
Source
Brief title
Condition
- Demyelinating disorders
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Can we find a significant difference between MS patients and healthy controles
focussed on the 5 ED parameters.
Secondary outcome
Not applicable.
Background summary
The relationship between Chronic cerebrospinal venous insufficiency (CCSVI) and
multiple sclerosis ( MS) is at the moment an important issue all over the
world. Zamboni et al (2009) proposed a causal relationship between raised
venous pressure and the inflammatory process of MS. He treated in an open-label
study 65 MS patients with percutaneous transluminal angioplasty (PTA). He
concluded PTA of the strictures and stenoses of the venous drainage of MS
patients influence positively the clinical course and outcome compared with the
preoperative assessment inclusive QOL parameters. We want to study 50 MS
patients, age and sex-matched with 50 healthy controls with extracranial Echo
Doppler (ED) and Transcranial Doppler (TCD). Only clinical definitive MS
patients (according to the revised MCDonald criteria) will be selected. Patient
demographics are age, sex, the Expanded Disability Status Score (EDSS),
Multiple Sclerosis Functional Composite score (MSFC), disease course, disease
duration and relapse rate Conform Zamboni et al (2009), we focus on 5
parameters indicative of CCSVI: 1-reflux in the internal jugular vein (IJV) or
in the vertebral vein (VV), or both with the head in any position, 2- reflux in
the deep cerebral veins, 3- high-resolution B-mode evidence of IJV stenoses, 4-
flow not detected by Doppler in the IJVs or VVs, or both, and 5- reverted
postural control of the main cerebral venous outflow pathways. The main point
of this study is to detect in a controlled fashion if there is a relationship
between CCSVI and MS.
Study objective
The main point of this study is to detect in a controlled fashion if there is a
relationship between CCSVI and MS. We focus on 5 parameters indicative of
CCSVI: 1-reflux in the internal jugular vein (IJV) or in the vertebral vein
(VV), or both with the head in any position, 2- reflux in the deep cerebral
veins, 3- high-resolution B-mode evidence of IJV stenoses, 4- flow not detected
by Doppler in the IJVs or VVs, or both, and 5- reverted postural control of the
main cerebral venous outflow pathways. Can we find a significant difference
between MS patients and healthy controles focussed on the 5 ED parameters.
Study design
The study is an observational study. We want to study 50 MS patients, age and
sex-matched with 50 healthy controls with extracranial Echo Doppler (ED) and
Transcranial Doppler (TCD). Only clinical definitive MS patients (according to
the revised MCDonald criteria) will be selected. Patient demographics are age,
sex, the Expanded Disability Status Score (EDSS), Multiple Sclerosis Functional
Composite score (MSFC), disease course, disease duration and relapse rate
Conform Zamboni et al (2009), we focus on 5 parameters indicative of CCSVI:
1-reflux in the internal jugular vein (IJV) or in the vertebral vein (VV), or
both with the head in any position, 2- reflux in the deep cerebral veins, 3-
high-resolution B-mode evidence of IJV stenoses, 4- flow not detected by
Doppler in the IJVs or VVs, or both, and 5- reverted postural control of the
main cerebral venous outflow pathways.
Study burden and risks
Minimal. We do Echo Doppler; duration 60 minutes.
Koekoekslaan 1
3435 CM NIeuwegein
NL
Koekoekslaan 1
3435 CM NIeuwegein
NL
Listed location countries
Age
Inclusion criteria
-Definite MS according the revised McDonald-criteria for MS.
Exclusion criteria
None
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL35381.100.11 |