|
|||||||||||
|
Treatment Administration Phase (continued) This process of “titration” or customizing therapeutic protocol per patient is not unfamiliar in procedures involving neuromodulation technology (e.g. electrical or electromagnetic stimulation). The investigator considers factors such as severity of symptoms, age, and presence of other medical conditions, and patient response to treatment. No two patients respond identically to a particular drug or dosage level, so this process involves experimentation, persistence, and patience. For this study protocol, customization of the study procedure administration protocol will commence during the first week of study procedure administration and may continue through the end of the fourth week of administration. Customization will be based upon a subject group’s response to a combination of the cognitive tests previously indicated and study consultant’s experience. A description of this titration process and the parameters is provided on the following page. After the investigator has optimized the study procedure administration parameters for each test group as described above, the remaining study procedure administration parameters shall be identical for each subject in a particular test group. Each test group however will have different study procedure administration parameters. Throughout the Treatment Administration Phase Additionally, the cognitive tests previously indicated may be administered by the study consultant or his staff during the treatment administration phase as more immediate measures of effectiveness to treatment by the Resonator. Blood Pressure will also be measured at the end of each treatment session. |
4700 140th Ave. N., Suite 101 • Clearwater, FL 33762 • 727-474-3722 |
