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Title:
Open Label Extension Study for Subjects Previously Treated in Either Pilot I or II Studies of the Application of Magnetic Fields Using the Resonator™ for the Treatment of Parkinson’ Disease.
Primary Purpose:
- Understand and quantify the capacity of a less intensive procedure regimen with the Resonator™ over a longer period (up to 11 months) to maintain the benefits for a subject attained following the initial intensive exposure phase.
- Gather more data specific to quality of life measures for Parkinson's patients
- Attain “Health Care Resource Utilization” data that will be important in establishing CMS/Third Party Payor reimbursement policies post-FDA market clearance of the Resonator™.
Design:
There will be one treatment group in this study with all subjects knowingly receiving active exposures to the Resonator™.
Subject Demographics:
There will be 3 potential subject groups in this study:
- Subjects who completed Pilot Study I and have not received any exposures to the Resonator™ for several months.
- Subjects who completed Pilot Study II and the 3-month wash-out phase of Pilot II and have therefore not received any exposures to the Resonator™ for at least 3 months
- Placebo subjects from Pilot II had accepted and are currently engaged in the post-study active exposure option and will not incur any break in exposures to the Resonator™.
Methodology:
Subjects will be treated with the Resonator™ for 12 months, the first two months they will receive 3 treatments/week @ 1.5 hrs per treatment, the last 10 months they will receive 1 treatment/week @ 1 hr per treatment.
Primary Study Outcome Measures:
Mean change across evaluation time points in:
- Scores on the UPDRS and its subscales in the routine “on” state
- The Hoehn & Yahr grade.
- Scores on the Schwab & England scale.
- 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 Pittsburgh Sleep Quality Inventory.
- Scores on the Epworth Sleepiness Scale
- Scores on the Fatigue Severity Scale.
- Scores on the Beck Depression Inventory II
- Timed tapping score
- Timed walking score
- Scores on the Modified Abnormal Involuntary Movement Scale
- Blood pressure measurements
Inclusion Criteria:
- Prior participation in pico-tesla pilot studies: IRC approval numbers 07102 & 07021.
- Willing/able to abstain from partaking in non-essential new treatments for PD symptoms during the course of participation. 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, hypnotherapy.
- Willing/able to abstain from all non-essential new medications that could affect PD and/or any of its associated symptoms for study duration.
- Willing to notify the investigator of any changes in medication use or therapies that is prescribed and deemed necessary by the subject’s physicians.
- Adequate contraceptive measures for females subjects.
- Capable of giving full written informed consent.
Exclusion Criteria:
- Not a participant in IRC 07102-01E or IRC 07021-02
- Subject currently does not present with strokes, active brain tumor(s), hydrocephalus, chronic Pain not associated with Parkinson’s Disease or any other condition which might prevent the subject from comfortably sitting/laying down for treatment period (1 ½ hours) including severe levodopa-induced dyskinesias.
- Consumption of medications that can produce drugs-induced parkinsonism including: Alpha-methyldopa, Metoclopramide, Neuroleptics (e.g., haloperidol, olanzapine, or risperidone), Reserpine and similar dopamine-depleting agents or Anti-emetics such as Compazine®)
- A 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.
- Epilepsy/history of seizures/taking medication for epilepsy; HIV and other autoimmune disorders; cancer within last 2 years; history of ECT; Diabetic Neuropathy; uncontrolled hypertension; or advanced Pulmonary Disease.
- Known heart conditions, such as a repetitive history of cardiac arrhythmias (including atrial fibrillation, ventricular fibrillation and irregular atrial-ventricular conduction time), congestive heart failure, and heart disease.
- Previous surgical interventions for Parkinson’s disease (i.e., deep brain stimulation, pallidotomy, stem cell implantation)
- Prosthetics comprised of ferrous metals, or those that otherwise interfere with the ability of subject to be ambulatory, or interfere with their function such that the investigator is not accurately able to assess subject’s function relative to study assessment tools.
- Stents only where there is also 1) a history of cardiac arrythmias (e.g. atrial fibrillation and repetitive autonomic dysfunction), and/or 2) a history of congestive heart failure with continuing breathing difficulties (i.e. pulmonary edema) and/or 3) advanced valvular stenosis with extensive regurgitation of blood and/or 4) unstable or uncontrolled vital signs and/or 5) extensive ischemic damage to the heart muscle as a result of one or more heart attacks.
- Pacemakers.
- Uncontrolled, unstable, or untreated medical illnesses which might potentially significantly affect the patient's health in the opinion of the investigator.
- Reported consumption of more than 21 alcoholic drinks per week.
- Pregnant, breast feeding, or planning pregnancy prior to the end of participation.
- Developmental disability or cognitive impairment that would make it difficult for the subject to partake in the clinical study, including adequate comprehension of the informed consent form and ability to record the necessary measurements.
- Inability to: maintain regular medication regimen throughout the study; abstain from partaking in new non-essential PD treatment during the study; or abstain from all new non-essential PD medications and those that may affect PD symptoms during the study unless deemed necessary by their physician.
- Not willing to report physician-mandated changes to medication/treatment regimen.
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