Subjects
Subjects will be those who voluntarily sign the subject informed consent form, pass the study qualification evaluation and are subsequently enrolled in the study.
Subject Recruitment
- Newsletter Ad (version 4.10, 07/01/10): The following newsletter ad is intended for:
(i) publication in various and appropriate Parkinson’s disease related newsletters designed for lay people such as those published by support groups; and
(ii) on web sites: including PicoTesla Magnetic Therapies (www.pico-tesla.com). The intended advertising material is as follows:
Research Study
This study is to see if a device called the Resonator is safe and can help to lessen the symptoms of Parkinson's Disease by putting out low strength magnetic fields around the body, as two smaller studies completed over the last two years suggest.
How Long Will the Study Last?
There are about 2 visits totaling about 2½ hours to decide if you are able to take part in the study and to evaluate your PD symptoms. If you qualify to take part, you will get 24 procedures with the device, three times a week for 8 weeks, about 1½ hours each time. Afterwards, there are 2 visits over one month to evaluate your PD symptoms. Each of these visits will take about one hour. You may receive $100-$750 for up to 27 visits.
Where Do I Need to Go?
The study takes place at: ______________
How Can I Take Part?
You may be eligible for the study if you have Parkinson’s Disease, can move around, and are between 30-85 years old. Men and women are both eligible. Some individuals with illnesses that cause Parkinson’s-type symptoms or whose diagnosis of PD is not clear may not be eligible.
Where Can I Get More Information?
Contact: ________________
- Newspaper Ad (version 1.5, 07/01/10): The following newspaper ad is intended for publication in local newspapers:
PARKINSON'S DISEASE
Research Study |
This study is to see if using a non-invasive, investigational device called the ResonatorTM using low-level magnetic fields can help to lessen the symptoms of Parkinson’s Disease.
Please call ____________ for details and to see if you may qualify for participation in this study. You may receive $100-$750 for up to 27 visits. |
Compensation of Subjects
A subject may receive up to $750 for his or her participation in the study, as follows:
- A subject who successfully qualifies for study participation, is enrolled in the study and successfully completes his or her first Resonator procedure administration visit will receive $100.
- At successful completion of the 8-week 24 Resonator procedure administration visits and the study endpoint assessment visit at the end of this 8-week procedure administration period, the subject will receive an additional $500.
- At successful completion of the follow up assessment visit one month after the last Resonator procedure administration, the subject will receive an additional $150.
Please note that ‘successful’ is used in this instance to indicate attendance and completion of all tasks for a specified visit, independent of the nature of the results.
In addition, the subject will also not be charged for the cost of the study procedure(s) with the Resonator™ device, or for the cost of any other directly-related evaluations or measurements that occur as part of his or her participation in the study.
Subject Sample Size
There will be 72 subjects enrolled in this clinical study:
- 36 subjects in the test group
- 36 subjects in the control group
Subject enrollment will occur approximately equally across study test sites.
Rationale for Sample Size
This study is powered to compare one active arm with placebo. Sample size calculation is based on the primary efficacy measure of the mean change from study baseline to endpoint (end of the 8-week treatment period) in Summary Index score on the PDQ-39 (PDQ-39SI) adjusted for the baseline PDQ-39SI score.
Based on detecting a mean difference of 4 points between test and placebo groups in the change in PDQ-39SI adjusted for the baseline PDQ-39SI score being considered clinically relevant with a SD of 5.55, a two-sided test with 80% power and a 5% level of significance, the number of subjects needed per treatment group is 31.
Therefore, a total of 62 subjects (31 test and 31 placebo) completing study participation is needed for any significant differences found between test and placebo groups to be considered statistically valid and representative of the general population being sampled.
From here, it is anticipated that about one-twelfth of subjects overall may withdraw from the study prior to completion for various reasons, including the number of study procedures involved. Therefore, the following formula is used to determine the final needed starting sample size for each group:
Final sample size = sample size X 1/(1-d); where d = # expected dropouts/# subjects enrolled.
Final sample size = 31 X 1/(1-0.097); where d = 3/31
Final sample size = 31 X 1/0.903 = 31 X 1.1074 = 34 subjects per treatment group.
Therefore, assuming an attrition rate of about 8-9%, a total of 34 subjects is needed to be randomized to test group and 34 to placebo group in order for a sufficient number of subjects (31 per treatment group) to remain at the end of the execution of the protocol for an analysis of outcomes between the three study test sites to be considered statistically valid. To facilitate execution of the randomization methodology, the enrollment size is increased slightly to 36 subjects per procedure group, for a total of 72 enrolled subjects.
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