While I continue to review the Lancet report I am convinced the writers ought to have identified gastronomy tube usage among the patients included in the study. Very little data on this issue appears in the report . . . one of the major reasons patients use gastronomy tubes is to decrease the risk of aspiration pneumonia.

The Lancet report also indicates 'no stimulation' is a possible 'sham stimulation,' whereas, in my estimation, 'sham stimulation' means stimulation other than 'no stimulation' or 'intended stimulation.' Its possible the complete absence of stimulation might be harmful in the presence of the implants because the implants may, in effect, cause short-circuits and thus increase the energy neurons must produce to sufficiently activation the synapse. The change in stress neurons may undergo might increase their load and thereby possibly reduce the neuron's longevity. A stimulation offsetting this effect ought to be possible - if it is needed.

The limited amount of French comment on the studies might in fact only be in reference to the Lancet report and thus the remarks implying the French study encountered trouble too is possibly only a rumor.

Possibly the most worrisome issue in the report are the two pulmonary embolisms. Until this report, I was aware of only one case, ending badly. Was this one of those two or are there now three . . . what happened of these two?

My understanding is pulmonary embolisms are always a surgical risk and people who live a sedentary lifestyle have a greater risk. So far no clear connection between the pacer and these embolisms are evident in the documentation I can find on the web. The first occurred within the thirty day surgery period; I can only find they occurred in the report, but not when, as yet.

The DiPALS report may be a study incurred of a false negative sample; In ALS a treatment group may appear to fair less successfully than the control group when the patient count is small. I have seen cases where a patient lasts only six months from disease onset to cases where a patient remains alive after fifty years from disease onset. So the patients lived less long in the treatment group; did they live longer than they would have? Efficacy is about whether they lived longer with than without the treatment.

Given a group of 37 ALS patients, we might expect to see seven slow regressors and presumably seven fast regressors (yet I know of very little literature on fast regressors).

This note pertains to Figure 2 of the DiPALS report in Lancet Neurology. There are tic marks on both lines in the chart: the upper line has about twenty of them and the lower line about ten. The caption regards them as indicating censored patients. The term censored is sometimes used to indicate cases excluded from consideration because of missing criterion(s): the report suggests some datums were instead interpolated because they were not received. I have wondered whether the tic marks indicate a patient passed the point where their speech was no longer intelligible? Such an indication would be scientifically valuable. Surely they do not mean they told the patient to shut up.

Prognostic factors in ALS: A critical review
Chio, et alia (Torino-Italy, Harvard, Dublin-Ireland, Dundee-Scotland, Preston-UK, Milano-Italy, NIH-USA)
Published 2009, "Amyotrophic Lateral Sclerosis"
http://www.tandfonline.com/doi/abs/1...82960802566824

Respiratory effects of amyotrophic lateral sclerosis: problems and solutions.
Lechtzin, Noah (Johns Hopkins)
Published August 2006, "Respiratory Care" Vol 51 No 8
http://www.ncbi.nlm.nih.gov/pubmed/16867198

A new status is posted on the ClinicalTrials.gov database for the French study:

"This study has been terminated.

(in the absence of benefits and because of a statistically significant excess mortality in the group of patients receiving active stimulation.)"

MuonOne
I appreciate your taking the time to keep ALS patients and caregivers so very well informed. I do not have ALS, but have been diagnosedwith Parkinson's for 20+ years.

There are many similarities between ALS and PD. By studying all neurological illnesses, I believe we will come closer to finding therapies that work. I want to thank Thelma for her work in this area, also.
Peggy

Thank you, pegleg, . . . indeed Parkinson's and Amyotrophic Lateral Sclerosis have many similar symptoms; both affect the motor nervous 'system' . . . but the 'dopamine' rather than 'glutamate' neurons are affected in Parkinson's. Advances in medical or biological science may help heal both disorders.

Thelma is one of my favorites, I only wish they would post more!

One of neurology's biggest problem is insufficient precision, . . . is the data sufficiently precise the conclusion validly follows therefrom? Such is the problem I think in the case of the question of whether females are at greater risk if they develop the disorder, even though they are believed to have a significantly lower risk incurring Amyotrophic Lateral Sclerosis.

There appear to be at least fourteen cases who have used the pacer and exceeded 'ten years alive' post-symptom onset . . . so far, . . . many remain candidates thereto . . . the expected number is seventeen (10% of patients are expected to reach ten years).