Company Research Policy
Electromedical Products International, Inc., the world headquarters for Alpha-Stim, makes every attempt to encourage research with its Alpha-Stim technology. While we do not fund research, we have developed several important ways in which we can support research in which our devices are used. They are as follows:
• We can assist researchers by making available to them a bibliography of past and ongoing studies, both published and unpublished. This can comprise the review of the literature prior to a study, and will provide researchers with knowledge of prior subjects studied and how they fared.
• We are in daily contact with clinicians around the world and can share research ideas that might answer the most frequently asked clinical questions that have not been researched, and the most interesting clinical observations that might be proven through research.
• We are knowledgeable regarding the needs and requirements of Alpha-Stim studies. We can assist in preparing your study design, especially the materials and methods section.
• We can arrange to have a statistician complete your study’s statistical analysis for you at our cost, if you wish.
• Upon receipt of an approved protocol we can lend you a reasonable number of Alpha-Stim devices set up as necessary including double-blinded (with the key provided in a sealed envelope) at no cost to you. We will also provide all the accessories, even batteries, you require to complete your study.
Alpha-Stim therapy is dosage-dependent, so the higher the current the quicker the treatment. For double-blinding, we set up the devices at only 100 µA which has proven subsensory in many studies completed to date. To compensate for the low current, the time must be increased to one full hour. Half the devices will be modified so as not to conduct any current at all. Since the active treatments are subsensory, this method allows for double-blinding as good as a pharma study using a placebo pill. Research has also shown that there is no reliable “washout” period. In some cases, continued improvement is seen as much as two years after a series of treatments. Accordingly, only one way crossovers are possible, from the sham treated group to an active treatment. This can be done maintaining the original subsensory criteria of 100 µA which would increase the N and allow for half the subjects to serve as their own controls. Alternatively, this optional second arm can use the original sham group in an open clinical trial where the current is raised to a comfortable level in the same way as it would be done in actual practice. This usually achieves better results while still allowing for the original sham subjects to serve as their own controls. We need a few weeks notice to build sham devices. Then we can either mark half with a dot and note which are which in the sealed study key, or we will simply mix them up and the only differentiation would be by serial number if the study allows for randomization by simply picking a device out of a box.
We are very pleased at your interest in possibly using Alpha-Stim technology in your research. Please do not hesitate to contact me at the telephone number or email address below at the first opportunity that we can be of assistance to you in this process.
Daniel L. Kirsch, PhD, DAAPM, FAIS
1-800-367-7246 x 110
email: dan@epii.com
