Study of Magnetic Fields for Treatment of Parkinson's Disease
A Double-blind, Sham-stimulation Controlled Study of the Application of Magnetic Fields Using the Jacobson Resonator for the Treatment of Parkinson's Disease.
1 other identifier
interventional
12
1 country
1
Brief Summary
The purpose of this study is to determine if low level magnetic fields may help to relieve symptoms of Parkinson's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 22, 2008
CompletedFirst Posted
Study publicly available on registry
October 24, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
July 8, 2011
CompletedJuly 12, 2011
July 1, 2011
1.8 years
October 22, 2008
May 13, 2011
July 7, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Inactive Resonator Therapy
PLACEBO COMPARATORInactive magnetic resonance therapy
Active Resonator Therapy
ACTIVE COMPARATORactive magnetic resonance therapy
Interventions
inactive magnetic field therapy with placebo fields
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
pico-tesla Magnetic Therapies
Littleton, Colorado, 80120, United States
Related Publications (1)
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
RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Allen S. Braswell CEO
- Organization
- Pico-Tesla Magnetic Therapies, LLC
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 22, 2008
First Posted
October 24, 2008
Study Start
August 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
July 12, 2011
Results First Posted
July 8, 2011
Record last verified: 2011-07