Study of Magnetic Fields for Treatment of Parkinson's Disease
This study has been completed.
Sponsor:
pico-tesla Magnetic Therapies, LLC
Information provided by:
pico-tesla Magnetic Therapies, LLC
ClinicalTrials.gov Identifier:
NCT00779155
First received: October 22, 2008
Last updated: July 7, 2011
Last verified: July 2011
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Purpose
The purpose of this study is to determine if low level magnetic fields may help to relieve symptoms of Parkinson's disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Device: The Resonator Device: The Resonator control |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-blind, Sham-stimulation Controlled Study of the Application of Magnetic Fields Using the Jacobson Resonator for the Treatment of Parkinson's Disease. |
Resource links provided by NLM:
Further study details as provided by pico-tesla Magnetic Therapies, LLC:
Primary Outcome Measures:
- Change From Baseline to Study End Point in the Combined Scores From the UPDRS Subscale II and III Recorded in the Subjects "on" State. [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]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.
| Enrollment: | 12 |
| Study Start Date: | August 2007 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Inactive Resonator Therapy
Inactive magnetic resonance therapy
|
Device: The Resonator control
inactive magnetic field therapy with placebo fields
|
|
Active Comparator: Active Resonator Therapy
active magnetic resonance therapy
|
Device: The Resonator
active magnetic field therapy
|
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- idiopathic PD with motor fluctuations of at least 3-4 hours daily., Subject on levodopa, subject is ambulatory, maintain regular med schedule, willing and able to abstain from new PD treatments, Able to demonstrate correct completion of PD diaries, non-demented, adequate contraceptive measures, capable of giving full written consent.
Exclusion Criteria:
- any factors that will prevent subject from completing full course of therapy with the resonator, any factors preventing subject from attending clinic in the "off" state, atypical parkinsonism, no active brain tumors, strokes, hydrocephalus, any other neurologic or non-neurologic disorder which might affect the symptomatic expression of pts. parkinsonism, suffers from chronic pain, no meds that may produce parkinsonism, no psychiatric disturbance, Epilepsy, HIV, Cancer, History of ECT, Diabetic Neuropathy, Uncontrolled HTN, Advanced Pulmonary Disease, Known heart conditions such as cardiac arrythmias, previous PD surgical interventions, prosthetics comprised of ferrous metals, pacemakers, DBS, Uncontrolled, unstable or untreated medical illnesses, Consumption of more than 21 alcoholic drinks per week, Pregnant, breast feeding, developmental disability
Contacts and Locations More Information
Publications:
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
| Responsible Party: | pico-tesla Magnetic Therapies, LLC |
| ClinicalTrials.gov Identifier: | NCT00779155 History of Changes |
| Other Study ID Numbers: | PD pilot 2 |
| Study First Received: | October 22, 2008 |
| Results First Received: | May 13, 2011 |
| Last Updated: | July 7, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on May 21, 2013