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Description of Measurements and Procedures
The following list comprises and describes the measurements, tests and assessments to be used in this pilot study.
- Measurement of subject height and weight: The subject’s height in meters, weight in kilograms will be measured.
- Blood pressure: Systolic and diastolic blood pressure will be measured in millimeters of mercury (mm Hg) using a sphygmomanometer. The subject’s blood pressure reading will be classified as follows:
| Category |
Systolic (mm Hg) |
|
Diastolic (mm Hg) |
| Normal |
less than 120 |
and |
less than 80 |
| Prehypertension |
120 - 139 |
or |
80 - 89 |
| Hypertension |
|
|
|
| Stage 1 |
140 - 159 |
or |
90 - 99 |
Source: The Seventh Report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure, American Heart Association.
N.B.: When a person's systolic and diastolic pressures fall into Different categories, the higher category is used to classify the blood pressure status.
- Alzheimer’s Disease Assessment Scale-Cog (ADAS-cog): Patients will be tested prior to initiation of the study, at completion of exposure (end of Week 12) to the fields and will be rescreened at 2 months following the last exposure.
- Neuropsychiatric Inventory Questionnaire (NPI-Q): Will be administered to study partner prior to initiation of the study, at completion of exposure to the fields and will be rescreened monthly during the procedure treatment (end of Weeks 4, 8, and 12) and also at 1 and 2 months following the last exposure.
- Clinical Dementia Rating Scale (CDR): Will be administered to subject and study partner prior to initiation of the study, at completion of exposure to the fields (end of Week 12) and will be rescreened at 1 and 2 months following the last exposure.
- Mini-Mental state examination (MMSE): Patient will be tested prior to initiation of the study, and completion of exposure to the fields (end of Week 12) and will be rescreened at 2 months following the last exposure.
- Modified ADCS Activities of Daily Living (ADL) Inventory (Galasko et al, 1997): Will be administered to study partner prior to initiation of the study, at completion of exposure (at the end of Week 12) to the fields and will be rescreened at 1 and 2 months following the last exposure.
- Clock Drawing: Will be tested during the treatment phase (Week 1-12) as a measure of effectiveness of the treatment.
- Category and Letter Fluency: Will be tested during the treatment phase (Week 1-12) as a measure of effectiveness of the treatment.
- Figure Copying: Will be tested during the treatment phase (Week 1-12) as a measure of effectiveness of the treatment.
- Number Cancellation: Will be tested during the treatment phase (Week 1-12) as a measure of effectiveness of the treatment.
- ADCS ADAS-cog Maze: Will be tested during the treatment phase (Week 1-12) as a measure of effectiveness of the treatment.
The last five tests listed above can be used by the treatment staff and study consultant, Dr. Jacobson, as measures to show effectiveness of the Resonator during the treatment phase, especially during the titration process. As shown in the case studies included in the Appendices, previous subjects have shown improvements in these types of measures after treatment with the Resonator. A separate battery of assessments is being used during the treatment phase than those used during the screening and re-evaluations to avoid subject’s familiarity of the tests. The results of the tests done during the treatment phase will not be shared with the Principal Investigator or the testing site research staff until the end of that subject’s participation.
Test Results
Subjects and/or their caregivers/guardians will be given the option of obtaining their test results or having them sent to their physician at the end of the study. Subjects will indicate their preferences at their last study visit.
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