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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Resonator magnetic field therapy | Administration of active magnetic fields with the Resonator Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resonator Device | Device | active pico-tesla magnetic fields treatment for Parkinson's disease individuals |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | baseline and 11 months |
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Inclusion Criteria:
Exclusion Criteria:
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Previous participants enrolled in one of two prior pico-tesla Magnetic Therapies Resonator device studies using magnetic fields for treating Parkinson's Disease (PD) symptoms.
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| Name | Affiliation | Role |
|---|---|---|
| Jerry I Jacobson, PhD., DMD. | pico-tesla Magnetic Therapies, LLC | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Resontaor Device Therapy | active pico-tesla magnetic fields Resonator device therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Resontaor Device Therapy | active pico-tesla magnetic fields Resonator device therapy |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | scores on a scale | baseline and 11 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Resontaor Device Therapy | active pico-tesla magnetic fields Resonator device therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allen S. Braswell CEO | Pico-Tesla Magnetic Therapies, LLC | 303 795-3222 | abraswell@pico-tesla.com |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
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| 0 |
| 18 |
| 0 |
| 18 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |