Study of the Application of Magnetic Fields for the Treatment of Parkinson's Disease
Primary Purpose
Parkinson's Disease, Quality of Life
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Resonator Device
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Quality of Life issues in Parkinson's disease
Eligibility Criteria
Inclusion Criteria:
- Idiopathic Parkinson's Disease
- Stable optimized anti-PD drugs for at least 4 weeks
- PDQ-39 Summary Index between 15 and 45
- Ambulatory
- Willing to maintain regular medication regime throughout study
- Able to abstain from starting in new treatments to improve PD symptoms during course of study.
- No prior surgical interventions for Parkinson's Disease
- Non-demented
- Minimum of 30 years of age, but not older than 85
- Capable of giving full written consent
Exclusion Criteria:
- Atypical Parkinsonism such as progressive supranuclear palsy, multiple system atrophy, CBDG etc.
- Subjects may not have any of the following: active brain tumor, strokes, hydrocephalus, any other neurologic or non-neuro problem which may affect symptomatic expression of patients parkinsonism.
- Consumption of medications that can produce drug induced parkinsonism
- Chronic pain not associated with PD
- Current or past history of major psychiatric disturbance
- No typical or non-typical anti-psychotics for treatment of drug induced psychosis.
- Chronic fatigue
- Epilepsy or history of epilepsy
- Seizures or taking medication for epilepsy
- HIV or other autoimmune disorders
- History of ECT
- Uncontrolled hypertension
- Advanced pulmonary disease
- Unstable cardiac disease
- Prior surgical interventions for Parkinson's disease
- Prosthetics or implants comprised of ferrous metals
- Pacemaker, vagus nerve stimulators, or other functional electrical stimulators such as those commonly used for pain
- Pregnant, breast feeding or planning pregnancy prior to study end
- Dementia, developmental disability, psychiatric disorder or other cognitive impairment
- Any significant medical condition that may require alteration of medical therapy during the study, or major medical condition which may interfere with the study activity.
Sites / Locations
- University of Colorado Health Sciences Center
- Mile High Research Center
- CNI Movement Disorders Center
- Suncoast Neuroscience Associates
- University of South Florida
- Detroit Clinical Research Center
Outcomes
Primary Outcome Measures
Change in PDQ-39 single index score
Secondary Outcome Measures
Full Information
NCT ID
NCT00863226
First Posted
March 13, 2009
Last Updated
December 13, 2011
Sponsor
pico-tesla Magnetic Therapies, LLC
1. Study Identification
Unique Protocol Identification Number
NCT00863226
Brief Title
Study of the Application of Magnetic Fields for the Treatment of Parkinson's Disease
Official Title
A Randomized, Double-Blind, Sham-Stimulation Controlled Study of the Application of Magnetic Fields Using the Resonator Device for the Treatment of Parkinson's Disease: Phase Three Clinical Trial Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
January 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
pico-tesla Magnetic Therapies, LLC
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to see if a device called the Resonator can help to improve aspects of health and quality of life that are relevant to patients with Parkinson's disease.
Detailed Description
This clinical trial will evaluate a new non-invasive, non-significant risk, device therapy as an adjuvant symptomatic treatment for some of the signs and or symptoms of Parkinson's Disease (PD). The device utilizes patented technology involving extremely low level electromagnetic fields.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Quality of Life
Keywords
Quality of Life issues in Parkinson's disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Resonator Device
Intervention Description
Application of Magnetic Fields Using the Resonator Device
Primary Outcome Measure Information:
Title
Change in PDQ-39 single index score
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Idiopathic Parkinson's Disease
Stable optimized anti-PD drugs for at least 4 weeks
PDQ-39 Summary Index between 15 and 45
Ambulatory
Willing to maintain regular medication regime throughout study
Able to abstain from starting in new treatments to improve PD symptoms during course of study.
No prior surgical interventions for Parkinson's Disease
Non-demented
Minimum of 30 years of age, but not older than 85
Capable of giving full written consent
Exclusion Criteria:
Atypical Parkinsonism such as progressive supranuclear palsy, multiple system atrophy, CBDG etc.
Subjects may not have any of the following: active brain tumor, strokes, hydrocephalus, any other neurologic or non-neuro problem which may affect symptomatic expression of patients parkinsonism.
Consumption of medications that can produce drug induced parkinsonism
Chronic pain not associated with PD
Current or past history of major psychiatric disturbance
No typical or non-typical anti-psychotics for treatment of drug induced psychosis.
Chronic fatigue
Epilepsy or history of epilepsy
Seizures or taking medication for epilepsy
HIV or other autoimmune disorders
History of ECT
Uncontrolled hypertension
Advanced pulmonary disease
Unstable cardiac disease
Prior surgical interventions for Parkinson's disease
Prosthetics or implants comprised of ferrous metals
Pacemaker, vagus nerve stimulators, or other functional electrical stimulators such as those commonly used for pain
Pregnant, breast feeding or planning pregnancy prior to study end
Dementia, developmental disability, psychiatric disorder or other cognitive impairment
Any significant medical condition that may require alteration of medical therapy during the study, or major medical condition which may interfere with the study activity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajeev Kumar, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jack Klapper, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen H Schechter, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olga Klepitskaya, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven Cohen, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert A Hauser, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Health Sciences Center
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Mile High Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
CNI Movement Disorders Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Suncoast Neuroscience Associates
City
St. Petersbury
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Detroit Clinical Research Center
City
Novi
State/Province
Michigan
ZIP/Postal Code
48337
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of the Application of Magnetic Fields for the Treatment of Parkinson's Disease
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