Clinical trials of CCSVI venoplasty procedures:
Healthy volunteers would be needed to test prevalence. What is needed here is a reliable diagnosis of CCSVI. If the IR or Vascular surgeon has been trained in Ferrara, or has a pedigree that is traceable to Ferrara, that should be no problem. Failing that, diagnosis could happen once the procedure is underway, assuming a high (8 or 9/10) rate, and informed consent has been obtained from definite MS sufferers.
Diagnosis of MS will have to be accepted, even though there is a high rate of misdiagnosis.
2. Sham Procedure Controls:
Testing for efficacy requires a sham procedure. Since the wound is slight, it should be possible to do a sham procedure without even entering a blood vessel if the subject is sufficiently sedated. The service of a good anesthesiologist should make it possible to make a small cut and bandage it, keeping subjects under sedation for a time which is randomly chosen between 45 minutes and 1.25 hours. The difference to a patient who was not conscious during the procedure will be limited to the effect on symptoms.
3. Placebo/sham termination:
Consensus should be reached in advance on a length of time Tr for results to appear. Whether and how to treat re-occurrence of symptoms should be left to the patient-doctor conversation. However, after the time Tr, having been consensually agreed upon between neurologists, vascular surgeons and interventional radiologists, the sham patients should be offered real venoplasty. Longer terms of efficacy should be tested without benefit of a sham cohort, since time is of the essence in treating progressive disease, MS has progression even before it is symptomatic, and it is never progression-free even during remission.
4. Substitute controls in longer trials:
If necessary, age, time-since-diagnosis, and/or disability matched controls can be substituted for sham patients who have been treated, to control for longer-term efficacy, as long as information has been collected over the time since the beginning of the trial, about relapse and/or progression of those matched controls.
That means a rigorous collection of this control information should have been done, starting now for any patients who intend to make themselves available as trial subjects. It should continue at appropriate intervals, until these patients either withdraw from candidacy, or are treated outside of a CCSVI trial, regardless of whether or when they enter one. It might be appropriate for the pertinent professions to come to some consensus on the nature, and schedule for collection of this data, as soon as possible. It should include as much as possible of the data collected in trials. Standards would be useful, such as EDSS and MSFC scores.
5. Placebo limits:
There is a limited time beyond which placebo is either ineffective or should be considered to have no more possibility of confounding the result. This time limit should be agreed in advance as well.
"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'MS' is over - if you want it
Patients sans/without patience