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Sample Approaches Group A – Sample Approach The second signal may be: 0.075 uG @ 5.0 Hz. The duration may be from 5 minutes to 20 minutes. Once again, based upon the experience of the study consultant, a duration of exposure may be established. It will be noted that the study consultant may discount the use of any signal during the course of this titration method, i.e. the investigator may decide during the course of titration that neither signal A nor signal B should be used for subsequent treatment sessions. The next signal that may be tested: 0.075 uG @ 5.3 Hz. Once again, the signal may be used from 5 to 20 minutes. The next signal may consist of any of the following combinations possible: 0.077 uG or 0.075 uG or 0.078 uG @ 6 Hz, 6.5 Hz, 7.0 Hz or 7.5 Hz. The exposure time may be 5 to 20 minutes for any signal, but if a signal is used for longer than 5 to 8 minutes, consideration will automatically be given to the total exposure time required. Other signals that may be utilized could include, but not be limited to the following: It will then be determined which signal or set of signals is appropriate for usage. The study consultant will always keep in mind that total treatment time must be established rapidly as signals are tested. Since the study consultant has clinical experience to draw from, assessment as to standardization of the protocol for the entire Group 1 will be accomplished within a reasonable time frame, eg 2-3 weeks. Note: The aforementioned possible sequences of signals will not all be used. They are stated as options for the study consultant’s use. He may deem it preferable to move in the following sequence, as an example:
OR, as another example, it might be advantageous to use just one signal:
The purpose of this study is to rapidly establish a protocol that can be utilized in a standardized manner, i.e. the same for all subjects in a treatment group. Group 2 – Sample Approach In this group the approach may begin at the following signal: 0.075 uG @ 7.5 Hz. From the response to this signal, it would then be determined whether to increase the frequency sequentially up to about 130 Hz, or higher – up to 280 Hz (which is highly unlikely); OR, to decrease the frequency at some point to 5 Hz. It is likely that when beginning the first session at 7.5 Hz the highest frequency generally considered is about 14 Hz, usually not greater than 25 Hz. Latitude in Group 2 would be taken to consider greater amplitudes than 0.075 uG, even up to 0.5 uG (although it is highly unlikely that this would be indicated), in addition to higher frequencies as indicated. |
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