Parkinson's Disease
Conditions
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.
Interventions
DEVICEResonator Device
active pico-tesla magnetic fields treatment for Parkinson's disease individuals
Sponsors
pico-tesla Magnetic Therapies, LLC
Eligibility
Sex/Gender
ALL
Age
30 Years to 82 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Resontaor Device Therapy active pico-tesla magnetic fields Resonator device therapy | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Active Resontaor Device Therapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Change in Parkinson's Disease Questionnaire-39 Single Index Score (PDQ-39SI)From Baseline to Study Endpoint of 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).
Time frame: baseline and 11 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Resontaor Device Therapy | Change in Parkinson's Disease Questionnaire-39 Single Index Score (PDQ-39SI)From Baseline to Study Endpoint of 11 Months | 4.96 scores on a scale | Standard Deviation 1.1 |