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Study Efficacy Evaluation Tools Mini Mental State Examination (MMSE): The MMSE is a brief 30-point questionnaire used to assess cognition, sampling various functions, including arithmetic, memory, orientation, repeating lists of words, language use and comprehension, and copying a drawing. Parkinson's Disease Questionnaire-39 (PDQ39): The PDQ-39 a self-administered, disease-specific questionnaire designed to measure aspects of health and quality of life that are relevant to patients with Parkinson's disease. In addition to a Summary Index score, there are 39 items addressing eight domains of health considered to be adversely affected by Parkinson's disease: (Please refer to the section titled: Parkinson's Disease Questionnaire-39 (PDQ-39) as the Primary Outcome Measure on pages 36 through 41 above for additional detailed information on PDQ-39 tool and its application as the primary outcome measure in this clinical study.) Unified Parkinson's Disease Rating Scale (UPDRS) in its entirety: The UPDRS was introduced in 1987 as an overall Parkinson's disease assessment scale to quantify all the motor and behavioral aspects of the disease as a single number. This allows the physician to assess easily the worsening or improvement of PD with treatment and time. This scale is, therefore, widely used in clinical research and drug trials. The rating scale compiles multiple categories within the following areas:
Parkinson’s Disease Non-Motor Symptom Assessment Scale (PDNMS): The PDNMS is a rating by the clinician to assess the severity and frequency of non-motor symptoms of Parkinson’s disease patients in 9 different domain categories and has been validated in an international study (Naidu et al., 2006). The clinician will rate the severity and frequency of each subject using a 4-point scale that ranges from 0 (none) to 3 (severe; major source of distress or disturbance to patient) for severity and from 1 (rarely) to 4 (very frequent [daily or all the time]) for frequency. Epworth Sleepiness Scale (ESS): The Epworth Sleepiness Scale was developed by Dr. Murray Johns of the Epworth Hospital in Melbourne, Australia. It is widely used by sleep professionals worldwide to measure the level of daytime sleepiness, a measure of sleep deprivation. There are 8 items that describe a routine daytime situation. The subject rates each item on a scale of the likelihood that he or she would doze off or fall asleep (in contrast to just feeling tired) during that activity. Scoring: Fatigue Scale: Fatigue Severity Scale: The Fatigue Severity Scale (FSS) is a method of evaluating fatigue in degenerative illnesses. The Fatigue Severity Scale (FSS) is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. The FSS consists of nine statements that explore severity of fatigue symptoms. The subject reads each statement and circles a number from 1 to 7 depending on how appropriate he or she feels the statement applied to them over the preceding week. A low value indicates that the statement is not very appropriate whereas a high value indicates agreement. Internal consistency for the Fatigue Severity Scale is high for specific illness groups and healthy controls. The scale clearly distinguished patients from controls and it was moderately correlated with a single-item visual analogue scale of fatigue intensity. In all patients, clinical improvement in fatigue was associated with reductions in scores on the Fatigue Severity Scale. Scoring is done by calculating the average response to all of the questions (adding up all the answers and dividing by nine). People with depression alone score about 4.5, but people with fatigue related to significant illness average about 6.5. Beck Depression Inventory®—II (BDI®–II): The Beck Depression Inventory®—II (BDI®–II) is in line with the depression criteria of the Diagnostic and Statistical Manual of Mental Health Disorders—Fourth Edition (DSM–IV). This new edition of the Beck Depression Inventory® is the most widely used instrument for detecting depression. It takes about five minutes to complete and is demonstrated to be highly clinically sensitive to measurement and change. The BDI–II consists of 21 items that assess the intensity of depression in clinical and normal patients. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression, evaluated over the period of the past two weeks. It has been validated for samples aged13-80 years. Reliability: Internal consistency (Cronbach’s alpha) is .92 for clinical patients and .93 for non-clinical individuals. Test-retest reliability is .93. Validity: Concurrent validity: two comparisons between BDI-II and its previous version resulted in correlations of .93 and .84, the latter using the take-home form. Other tests found BDI-II to be correlated with the Beck Hopelessness Scale (.68), Scale for Suicide Ideation (.37), Beck Anxiety Inventory (.60), Hamilton Psychiatric Rating Scale for Depression-Revised (.71), and Hamilton Rating Scale for Anxiety - Revised (.47). Scoring: Most items on the BDI-II are rated on a 4-point scale ranging from 0 to 3. Several items have seven response options to discern differences in behavior or motivation. The BDI-II is scored by adding the ratings for the 21 items. The maximum total score is 63. Clinical interpretation of total scores uses the following guidelines: 0 to 13 (minimal depression), 14 to 19 (mild depression), 20 to 28 (moderate depression), and 29 to 63 (severe depression). Timed Finger Tapping Motor Speed Test: Mechanical counters are placed 30 centimeters apart and the subject is asked to tap the counters back and forth with each hand individually as many times as possible in 60 seconds. The sum of the two counters provides an indication of motor function. The test, questionnaire, scale and index tools listed in the Study Test Battery above are contained in Appendix B. |
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Doctor’s looking to refer patients suffering from Parkinson’s disease can contact Pico-Tesla for information on their clinical trials, now being conducted in Colorado, Michigan and Florida. During the trial, patients will be exposed to a low strength magnetic field around their body to test how this new pulsed magnetic therapy treats symptoms of Parkinson’s disease. Patients must qualify for the clinical trial, and also complete the procedure, before they can be compensated. All Pico-Tesla office locations where these clinical trials are being held are in close proximity to major cities in each state. Any interested party can contact Pico-Tesla for more information. |
