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Primary Purpose of the Study
The purpose of this phase three clinical trial is to demonstrate the efficacy of the Resonator™ device, manufactured by pico-tesla Magnetic Therapies, LLC (the Sponsor), as an adjunctive therapy to improving aspects of health and quality of life that are relevant to patients with Parkinson's Disease. Accordingly Sponsor plans on submitting the data and analysis of this trial via a 510(k) de novo application to obtain FDA clearance to sell the device.
Design
Placebo-controlled, randomized, double-blind parallel group multiple center design.
Methodology
Subjects will be treated with the Resonator™ device three times per week for a total of 8 weeks at approximately 1.5 hrs per treatment.
Primary Study Outcome Measures
The mean change from baseline to end of the treatment period (study endpoint) in the single index score of the PDQ-39.
Secondary Outcome Measures
Mean change across evaluation time points in:
- Scores on the UPDRS and its subscales in the routine “on” state
- Scores on the PD non-motor symptom assessment scale
- Scores on the individual subscales of the PD Rating scale-39 (PDQ-39)
- Scores on the EQ-5D
- Scores on the Epworth Sleepiness Scale
- Scores on the Fatigue Severity Scale.
- Scores on the Beck Depression Inventory II
- Timed tapping score
Inclusion Criteria
Current diagnosis of Idiopathic Parkinson's disease made by the study PI according to the UK Parkinson’s Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria for PD, Steps 1 & 2. (Hughes AJ, Daniel SE, Kilford L, Lees AJ. Accuracy of clinical diagnosis of idiopathic Parkinson’s disease. A clinico-pathological study of 100 cases. JNNP 1992;55:181-184).
- All prior relevant medical records regarding each subject will be obtained prior to study enrollment.
- Subject treated with carbidopa/levodopa, dopamine agonists, COMT inhibitors or MAOB inhibitors and other anti-PD drugs must be on stable optimized doses for at least 4 weeks prior to initial screening test and remain stable throughout the study.
- At the time of enrollment all subjects must be receiving optimal medical therapy. Furthermore, at the time of enrollment, in the judgment of the PI the subject should be unlikely to require alteration of their standard medical treatment regimen over the duration of the study.
- PDQ-39 Summary Index score of 20 or greater.
- Subject is ambulatory.
- Willing and able to maintain his or her regular medication regimen, and not alter same throughout the course of the study. Note: subjects with early Parkinson’s disease may be on NO medication regimen IF this is considered appropriate by the Principal Investigator and subject displays little functional disability.
- Willing and able to abstain from partaking in new treatments to improve Parkinson's disease symptoms during the course of participation in the study. Such treatments include new medications (other than those already comprising their regular medication regimen), dietary/herbal supplements/minerals, physical therapy, rTMS, surgical procedures such as DBS, alternative therapies such as acupuncture, massage, or hypnotherapy.
- Willing and able to abstain from all new medications that could affect Parkinson's disease and/or any of its associated symptoms for the duration of the study. Specifically, these medications are:
- alpha-methyldopa
- metoclopramide
- neuroleptics: e.g. haloperidol, olanzapine, or risperidone
- reserpine and similar dopamine-depleting agents
- anti-emetics such as Compazine or reglan
- Non-demented, as evidenced by a score of 26 or greater on the MMSE.
- Adequate contraceptive measures for female subjects.
- Minimum of 30 years of age, but not older than 85.
- Capable of giving full written informed consent.
Exclusion Criteria
- Any factors that might prevent the subject from completing a full course of therapy with the Resonator™ device or might prevent the subject from attending any of the scheduled follow up visits during the planned 5 month study.
- Atypical parkinsonism caused by neurodegenerative disorders other than idiopathic Parkinson's disease such as progressive supranuclear palsy, multiple systems atrophy, cortico basal degeneration, etc..
- Subjects may not have any of the following other disorders:
- active brain tumor(s)
- strokes
- hydrocephalus
- any other neurologic or non-neurologic disorder which might affect the symptomatic expression of the patient's parkinsonism
- Subject suffers from chronic pain not associated with Parkinson’s Disease.
- Any other significant comorbidities that might impact the ability to rate the UPDRS or other rating scale scores.
- Consumption of medications that can produce drug-induced parkinsonism including the following:
- alpha-methyldopa
- metoclopramide
- neuroleptics e.g., haloperidol, olanzapine, or risperidone
- reserpine and similar dopamine-depleting agents
- anti-emetics such as Compazine
- Current or past history of major psychiatric disturbance (e.g., schizophrenia, bipolar disorder, substance abuse). However, subjects with a history of treated depression or anxiety disorders will not be excluded. Anti-depressant drug therapy must be stable for at least 4 weeks prior to study entry and must remain stable throughout the duration of the study.
- Subjects may not be taking typical or atypical anti-psychotics for treatment of drug-induced psychosis
- Chronic Fatigue Syndrome
- Epilepsy/history of seizures/taking medication for epilepsy
- HIV and other autoimmune disorders
- Active cancer or treatment for cancer within last 6 months
- History of ECT
- Uncontrolled Hypertension
- Advanced Pulmonary Disease
- Unstable cardiac disease, such as any history of cardiac arrhythmias (including atrial fibrillation, ventricular fibrillation, or irregular atrial-ventricular conduction time), or any incidences of congestive heart failure, or myocardial infarction, within the last six months.
- Previous surgical interventions for Parkinson’s disease (i.e., deep brain stimulation, pallidotomy, stem cell implantation)
Prosthetics or implants comprised of ferrous metals, Pacemakers, vagus nerve stimulators, or other functional electrical stimulators such as those commonly used for pain.
- Reported consumption of more than 21 alcoholic drinks per week
- Pregnant, breast feeding, or planning pregnancy prior to the end of participation
- Dementia due to Parkinson’s disease or any other cause
- Developmental disability, psychiatric disorder, or other cognitive impairment that would in the judgment of the PI impair adequate comprehension of the informed consent form or complete any of the study-related activities.
- Any significant medical condition that may require alteration of medical therapy during the study, or major medical condition which may interfere with the study activity, in the judgment of the Principal Investigator.
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