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Post-Treatment (Washout) Analysis Efficacy analysis of post-treatment (follow-up phase) assessment will be via the ANCOVA model, with Bonferroni-Holm adjustment to correct for multiple comparisons. Safety analyses will be based on all subjects who were randomized to test or placebo procedure group, completed the baseline assessment, and received at least the first study procedure with the Resonator™ device. Safety will be assessed by evaluating and comparing frequency and incidence of observed and/or reported adverse events between test and placebo procedure groups. A chi-square test with a continuity correction will be performed to compare the percentage of subjects who had adverse events and/or reactions between the test and placebo group subjects. Anticipated potential adverse events resulting from use of the Resonator™ device are:
Formal evaluation of the occurrence of any of these and any other adverse events will take place at the end of each week of a subject’s participation in this clinical study. In addition, subjects will be instructed to contact the investigator at any other time that he or she believes an adverse event has occurred during the course of the subject’s participation in the clinical study. The investigator will record the observation or report of any adverse event and assign the relationship to the study intervention on the appropriate case report form in the subject’s file and will report the occurrence to the governing IRB, if and as appropriate, within 5 days of the reported occurrence, or within 24 hours in the occurrence of a serious adverse event including death. Adverse events will include any baseline symptoms which increase in duration, frequency, or intensity greater than that which could reasonably be expected given the variable nature of Parkinson's disease. |
4700 140th Ave. N., Suite 101 • Clearwater, FL 33762 • 727-474-3722 |
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