New hypothetical benefits spreadsheet shows diaphragm ranging data; the pacer may enable advancement in the scientific understanding of respiratory muscles, allowing more general deployment of the treatment in medical research - Barbara Brenner advocated unsuccessfully for. When clinical trial protocol is established, getting live change to be made thereto is very difficult, if not impossible because of potential legal repercussions due to non-perfected assessments of risks to patients and sponsoring organization(s). There may be some chance of permitting the involvement of some of these type of patients in every new clinical study but advocacy is likely needed. Essentially such was where Barbara Brenner's (BBZinger) efforts were going. "Per protocol" keeps risks in the 'channel,' violating protocol can disrupt the legitimacy of the clinical trial. Such risk can be very difficult to assess.

The orange highlight is added because I discovered, in 'my' downloaded version of the DiPALS trial report patient FVC needed to be 75% or less in order to be admitted to the trial. Thus twenty-five percent of the eligible patients per the FDA protocol were not allowed to enter the trial. The twenty-five percent excluded tended to be the strongest candidates. Of course this would have an considerable negative impact on the summary statistics for the trial.

Hypothetical Benefit

Resistance may continue to be experienced by pacing patients in participating in trials but there is likely no scientific legitimacy thereto because such patients would likely help the clinical trail obtain early indication of trial's sought after result, especially if the impact of ALS on the respiration muscles is studied to the point of perfecting such knowledge.

I have not received news from any patient regarding use of creatine and pulmonary pacing . . . creatine has not been helpful to ALS patients but might be helpful to pacing ALS patients.