This Is MS Multiple Sclerosis Community: Knowledge & Support

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. 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.

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).

Surface EMG characteristics of people with multiple sclerosis during static contractions of the knee extensors

Summary
Objectives:  This study was designed to determine whether any alterations existed in surface electromyography (sEMG) in people with multiple sclerosis (MS) during isometric contractions of the knee extensors.

Methods:  Fifteen people with MS and 14 matched controls (mean ± SD age and body mass index 53·7 ± 10·5 versus 54·6 ± 9·6 years and 27·7 ± 6·1 versus 26·5 ± 4, respectively) completed 20%, 40%, 60% and 80% of their maximal voluntary contraction (MVC) of the knee extensors. sEMG was recorded from the vastus lateralis where muscle fibre conduction velocity (MFCV) and sEMG amplitude (RMS) were assessed. Body composition was determined using dual-energy X-ray absorptiometry and physical activity with the use of accelerometry.

Results:  People with MS showed significantly (P<0·05) faster MFCV during MVC (6·6 ± 2·7 versus 4·7 ± 1·4 m s−1) and all submaximal contractions, while RMS was significantly (P<0·05) less (0·11 ± 0·03 versus 0·24 ± 0·06 mV) in comparison with the controls. MVC along with specific thigh lean mass to torque, rate of force development and mean physical activity were significantly (P<0·01) less in PwMS.

Conclusion:  People with MS have elevated MFCV alongside reduced RMS during isometric contraction. This elevation in MFCV should be accounted for when interpreting sEMG from people with MS.

Not to worry before the barn door is closed, or something... But it does sound like promising technology.

I do not understand how this test is better at weeding out the placebo effect than an MRI?

So...what is wrong with a sham treatment arm? The PREMiSe trial by the University at Buffalo Neurosurgery & BNAC is testing 20 people, all get catheter venograms with IVUS, and 10 also get venoplasty. Among a battery of other tests, all of which are the most extensive I have ever received in 10 years after MS dx. I will be there today for my 1 year follow-up exam. I truly do not know which arm of the study I am in. I'd prefer to find out I was in the sham arm, as I have seen no positive change since my procedure. So hope is still alive!

I feel any risk I have undertaken in minimal, the neurosurgeons involved are world class, the follow up care is terrific.

The payoff in research is worth my risk. I would feel far more at risk in a drug trial where the side effects are unknown, and even less is known about long term effects.

The PREMiSe trial by the University at Buffalo Neurosurgery & BNAC is testing 20 people, all get catheter venograms with IVUS, and 10 also get venoplasty.

The work at Sterling is in conjunction with EHC. MarkW

And the practical logistics: neck soreness alone might give it away, although not every patient reports neck soreness afterwards.

I once talked to a research assistant that was recruiting for a trial that had an arm using the test medication, another on Rebif and the placebo arm on saline solution. I scoffed at how it could be blinded as to who had Rebif and who was on saline because of Rebifs' side effects. She said I would be surprised how many people on saline solution had Rebif like side effects.

The sore neck could also be attributable to the investigative side, if it was explained to them as such.

So...what is wrong with a sham treatment arm? The PREMiSe trial by the University at Buffalo Neurosurgery & BNAC is testing 20 people, all get catheter venograms with IVUS, and 10 also get venoplasty. Among a battery of other tests, all of which are the most extensive I have ever received in 10 years after MS dx. I will be there today for my 1 year follow-up exam. I truly do not know which arm of the study I am in. I'd prefer to find out I was in the sham arm, as I have seen no positive change since my procedure. So hope is still alive!

I feel any risk I have undertaken in minimal, the neurosurgeons involved are world class, the follow up care is terrific.

The payoff in research is worth my risk. I would feel far more at risk in a drug trial where the side effects are unknown, and even less is known about long term effects.

So...what is wrong with a sham treatment arm? The PREMiSe trial by the University at Buffalo Neurosurgery & BNAC is testing 20 people, all get catheter venograms with IVUS, and 10 also get venoplasty.