Condition category
Nervous System Diseases
Date applied
31/03/2011
Date assigned
10/06/2011
Last edited
10/06/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Raj Attariwala

ORCID ID

Contact details

1371 West Broadway
Vancouver
V6H 1G9
Canada
+1 604 733 4007
rattariwala@aimmedicalimaging.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Pulsed short magnetic resonance imaging (MRI) to quantify neck vascular flow changes after jugular venous dilation (venoplasty) in patients with multiple sclerosis

Acronym

Study hypothesis

Venous narrowing and thus reduction in jugular vein flow has recently been implicated as a potential contributing factor in Multiple Sclerosis. Jugular venoplasty has been hypothesised to improve jugular venous drainage, and thus improve the symptoms of patients suffering with multiple sclerosis. Many patients have had magnetic resonance imaging (MRI) examinations assessing neck vein and arterial blood flow prior to venoplasty. The aim of this observational study is to use MRI scans to compare the the change in the blood flow in the neck vessels of patients after jugular veinoplasty with their pre-procedural flow measurements

Ethics approval

Not provided at time of registration - IRB Services approval pending as of 31/03/2011

Study design

Single centre observational longitudinal case control study

Primary study design

Observational

Secondary study design

Non randomised controlled trial

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

Multple sclerosis/ diagnostic imaging

Intervention

Observations:
1. MRI flow quantification will be used to measure blood flow rate averaged over 2 minutes within the right and left internal jugular veins
2. At the same level within the upper neck, left and right arterial blood flow will be measured
3. A ratio of total jugular vein to arterial blood flow will be calculated, and compared to the same measurements and site obtained on pre-procedural MRI scans
4. The change in percentage blood flow will be statistically analysed using the paired t-test

Patients will be provided with a questionnaire form to assess for quality of life changes at the time of the study. This questionnaire includes the following questions:
1. Date and location of CCSVI treatment (venoplasty)
2. Age of diagnosed MS
3. Age of suspected onset, type of MS, current medication, iron chelation or naturopathic treatments, vitamin D supplements
4. Effects pre and post therapy:
4.1. Cold extremities (pre/post)
4.2. Brain fog (pre/post)
4.3. Head fullness (pre/post)
4.4. Fatiguability (hrs of productivity) (pre/post)
4.5. Exercise tolerance (pre/post)
4.6. Colorperception/vision change (post)
4.7. Taste/smell change (post)
4.8. Hearing change (post)
4.9. Temperature tolerance (pre/post)
4.10. Bowel/bladder incontinence change (pre/post)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Paired t-test statistical analysis will be used to assess for significance

Secondary outcome measures

Questionnaire answers will be tabulated to assess for change

Overall trial start date

01/04/2011

Overall trial end date

30/06/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Above 19 years of age
2. Has been diagnosed with multiple sclerosis
3. Has an MRI of the neck veins with flow quantification prior to having jugular venoplasty (CCSVI treatment) within the past 1 year

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Pilot study of 25-50 participants

Participant exclusion criteria

1. Patients who have a contraindication to MRI scan
2. Patients with metal implants such as:
2.1. In the eye
2.2. Non-MRI compatible stents
2.3. Staples

Recruitment start date

01/04/2011

Recruitment end date

30/06/2011

Locations

Countries of recruitment

Canada

Trial participating centre

1371 West Broadway
Vancouver
V6H 1G9
Canada

Sponsor information

Organisation

AIM Medical Imaging (Canada)

Sponsor details

1371 West Broadway
Vancouver
V6H 1G9
Canada
+1 604 733 4007
appointments@aimmedicalimaging.com

Sponsor type

Hospital/treatment centre

Website

http://www.aimmedicalimaging.com

Funders

Funder type

Hospital/treatment centre

Funder name

AIM Medical Imaging (Canada)

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