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Functional Changes Following Percutaneous Venoplasty in Multiple Sclerosis Patients

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ClinicalTrials.gov Identifier: NCT01555684
Recruitment Status : Withdrawn
First Posted : March 15, 2012
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Dr Angus Hunter, University of Stirling

Study Description
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Brief Summary:

Multiple Sclerosis (MS) is a demyelinating disease of the central nervous system (CNS) that often results in reduced muscle function which produces fatigue, weakness and a decline in daily mobility. Although the underlying cause of the disease is unknown a possible contributory mechanism is chronic cerebrospinal venous insufficiency (CCSVI). Post-mortem studies and magnetic resonance venography have shown a strong relationship between the cerebral venous system and MS cortical plaques. From this a role for CCSVI in MS has been suggested: venous malformations that result in venous hypertension, pressure on the blood brain barrier and subsequent inflammation due to leakage of haemosiderin into the parenchyma. This provokes an immune response which results in neurodegeneration. A procedure known as percutaneous venoplasty whereupon a balloon is inserted and inflated into the jugular vein has been developed to improve this drainage of the CNS, reduce venous hypertension and improve symptoms associated with MS. Although this procedure is widely practiced throughout the world it has yet to be fully accepted as it needs to be supported by evidence based clinical trials. As such NHS National Institute for Health and Clinical Excellence (NICE) recently issued a consultation document to determine more about the procedure's clinical safety and efficacy. A common concern raised is the ability to prevent any possible placebo effect and like any other clinical trial should offer a sham procedure to a matched control group. The difficulty with this option are the ethical issues associated with an invasive sham treatment and also the practical issues of masking a potentially painful treatment such as venoplasty. One option is to have blinded neurological assessment of patients who have either been treated with venoplasty or had no active treatment. Another option is to use dependent measures that are unaffected by motivational or psychological influences which avoids any placebo effect issue. One such dependent measure is motor unit firing behaviour whilst contracting at a submaximal target force. Typically clinicians have used this to manage motor disorder patients but have used cumbersome invasive technology that can only measure a few motor units with limited accuracy. However, De Luca et al recently developed a high density surface electromyographic (HDsEMG) system that can measure 30-40 motor units with 92-97% accuracy. From this it has been proposed as a highly effective tool for evaluating efficacy of therapeutic interventions for upper motoneuron disorders such as MS.

Accordingly the investigators propose to use a repeated measures design on an experimental (receiving venoplasty) and control (not receiving venoplasty) MS groups (6 patients in each group) to determine the effect of the treatment on muscular function, mobility and fatigue. This would be combined with independent blinded neurological assessment of the two groups of patients.

This design enables us to achieve two aims:

  1. Acute neuromuscular response to the treatment
  2. Chronic response to the treatment (6 weeks) to determine the effect on muscular function, mobility and fatigue.*

Methods

  • Four (first two to establish baseline variability of measures) repeat visits to the laboratory at University of Stirling to establish neuromuscular measures:

    1. HDsEMG pre and post tetanic induced fatigue
    2. Muscle fibre conduction velocity as previously described (Hunter et al., 2011)
    3. Ultrasound for CCSVI determination on visits 1 and 3
    4. DEXA scans for alterations in body composition on visits 2 and 4
  • With the use of accelerometers monitor free living activity on days 0-7 and 9-42 (post venoplasty).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Chronic Cerebrospinal Venous Insufficiency Procedure: percutaneous venoplasty to alleviate chronic cerebrospinal venous insufficiency Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Percutaneous Venoplasty on Muscular Function, Mobility and Fatigue of Multiple Sclerosis (MS) Patients With Chronic Cerebrospinal Venous Insufficiency (CCSVI).
Study Start Date : April 2012
Actual Primary Completion Date : November 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: venoplasty proceedures
Half of the participants receive treatment and the other half do not
 Procedure: percutaneous venoplasty to alleviate chronic cerebrospinal venous insufficiency
percutaneous venoplasty is where a balloon is inserted and inflated into the jugular vein has been developed to improve this drainage of the CNS, reduce venous hypertension and improve symptoms associated with MS
Placebo Comparator: Control - no treatment Procedure: percutaneous venoplasty to alleviate chronic cerebrospinal venous insufficiency
percutaneous venoplasty is where a balloon is inserted and inflated into the jugular vein has been developed to improve this drainage of the CNS, reduce venous hypertension and improve symptoms associated with MS


Outcome Measures
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Primary Outcome Measures :
  1. Neuromuscular function [ Time Frame: 52 days ]
    The venoplasty procedure will be performed at 8 days


Secondary Outcome Measures :
  1. Free living activity [ Time Frame: 0-7 and 9-52 days ]
    Measured by accelerometery


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of CCSVI using transcranial and extracranial colour Doppler sonography in both supine and sitting positions. The diagnosis requires that 2 or more of the following 5 criteria are met:

    • reflux in the internal jugular or vertebral veins, or both, with the head in any position
    • reflux in the deep cerebral veins
    • high-resolution B-mode evidence of internal jugular vein stenosis
    • absence of Doppler-detectable flow in the internal jugular veins and/or vertebral veins
    • loss of postural control of the main cerebral venous outflow pathways.

Exclusion Criteria:

  • non ambulatory
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01555684


Locations
United Kingdom
University of Stirling
Stirling, United Kingdom, FK94LA
Sponsors and Collaborators
University of Stirling
More Information
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Publications:

Responsible Party: Dr Angus Hunter, Principal Investigator, University of Stirling
ClinicalTrials.gov Identifier: NCT01555684     History of Changes
Other Study ID Numbers: SPREC#501
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: December 2015

Keywords provided by Dr Angus Hunter, University of Stirling:
MS
CCSVI

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Venous Insufficiency
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases