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The purpose of this study is to determine if low level magnetic fields may help to relieve symptoms of Parkinson's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inactive Resonator Therapy | Placebo Comparator | Inactive magnetic resonance therapy |
|
| Active Resonator Therapy | Active Comparator | active magnetic resonance therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Resonator | Device | active magnetic field therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Study End Point in the Combined Scores From the UPDRS Subscale II and III Recorded in the Subjects "on" State. | The UPDRS is used to measure different aspects of Parkinson's Disease (PD). The UPDRS subscale II assesses how PD affects a person's daily life, with scores ranging from 0-52, with 52 representing greatest severity. The UPDRS subscale III assesses how PD affects how a person moves about, with scores ranging from 0-108, with 108 representing greatest severity. The combination of these 2 scores is used in clinical trials and in clinical practice to get a good overall idea of how PD affects a person's life. Combined score ranges from 0-160, with 160 being greatest severity. | Baseline and 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| pico-tesla Magnetic Therapies | Littleton | Colorado | 80120 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | O. Klepitskaya, R. Kumar, Efficacy and Safety of Low Level Electromagnetic Fields Treatment in Parkinson's Disease. Movement Disorders; Vol. 23, No. 11, 2008, pp. 1628-1637 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Inactive Resonator Device | inactive magnetic fields with placebo fields |
| FG001 | Active Resonator Device | Active pico-tesla magnetic fields |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inactive Resonator Device | inactive magnetic fields with placebo fields |
| BG001 | Active Resonator Device | Active pico-tesla magnetic fields |
| Units | Counts |
|---|---|
| Participants |
|
| 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 From Baseline to Study End Point in the Combined Scores From the UPDRS Subscale II and III Recorded in the Subjects "on" State. | The UPDRS is used to measure different aspects of Parkinson's Disease (PD). The UPDRS subscale II assesses how PD affects a person's daily life, with scores ranging from 0-52, with 52 representing greatest severity. The UPDRS subscale III assesses how PD affects how a person moves about, with scores ranging from 0-108, with 108 representing greatest severity. The combination of these 2 scores is used in clinical trials and in clinical practice to get a good overall idea of how PD affects a person's life. Combined score ranges from 0-160, with 160 being greatest severity. | Analysis was by intention to treat and all enrolled subjects completed the entire protocol. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and 8 weeks |
|
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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 | Inactive Resonator Device | inactive magnetic fields with placebo fields |
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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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| The Resonator control |
| Device |
inactive magnetic field therapy with placebo fields |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
inactive magnetic fields with placebo fields
| OG001 | Active Resonator Device | Active pico-tesla magnetic fields |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Active Resonator Device | Active pico-tesla magnetic fields | 0 | 6 | 0 | 6 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |