Evaluation of Long-term Effect of Resonator Therapy on Parkinson's Disease (PD)
- Conditions
- Parkinson's Disease
- Interventions
- Device: Resonator Device
- Registration Number
- NCT00862537
- Lead Sponsor
- pico-tesla Magnetic Therapies, LLC
- Brief Summary
An extension study for subjects with prior participation in previous resonator studies using low level magnetic fields to treat some of the symptoms of idiopathic Parkinson's Disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- Prior participation in pico-tesla pilot studies: NCT00779155 & NCT00863226
- Willing and able to abstain from partaking in non-essential new treatments for Parkinson's disease symptoms during the course of participation of the study.
- Will and able to abstain from all non-essential new medications that could affect PD and/or any of its associated symptoms for the duration of the study.
- Willing to notify the investigator right away of any changes in medication use or therapies that is prescribed and deemed necessary by the subjects physicians.
- Adequate contraceptive measures for female subjects
- Capable of giving full written informed consent
- Not a participant in IRC#'s 07102 or 07021
- No active brain tumors, strokes, hydrocephalus
- Chronic pain not associated with PD
- Any other condition which might prevent subject from comfortably sitting for 1.5 hours
- Consumption of medications that can produce Parkinsonism type symptoms
- Major psychiatric disturbance
- Epilepsy
- HIv and other autoimmune disorders
- Cancer within last 2 years
- History of ECt
- Diabetic neuropathy
- Uncontrolled HTN
- Advanced Pulmonary disease
- Known heart conditions such as repetitive history of cardiac arrythmias
- Previous surgeries for PD
- Prosthetics comprised of ferrous materials
- Stents, only where there is also cardiac arrythmias, CHF, advanced valvular stenosis, unstable vital signs, extensive ischemic damage to 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
- Consumption of more than 21 alcoholic drinks per week
- Pregnant, breast feeding or planning pregnancy
- Developmental disability or cognitive impairment
- Inability to maintain regular medication regime
- Inability to abstain from partaking in new non-essential PD tx., or medications
- Not willing to report physician mandated changes in medication and/or treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Active Resonator magnetic field therapy Resonator Device Administration of active magnetic fields with the Resonator Device
- Primary Outcome Measures
Name Time Method Change in Parkinson's Disease Questionnaire-39 Single Index Score (PDQ-39SI)From Baseline to Study Endpoint of 11 Months baseline and 11 months The Parkinson's Disease Questionnaire (PDQ-39) is a 39-item quality of life questionnaire for patients with Parkinson's Disease (PD) that evaluates the 8 dimensions of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, and communication. The PDQ-39 Single Index (SI) score is the weighted addition of scores on all 8 dimension and ranges from 0 (no disease impact) to 100 (severe disease impact).
- Secondary Outcome Measures
Name Time Method